Posttraumatic Stress Disorder
Conditions
Keywords
posttraumatic stress disorder, Veterans, Psychotherapy, Randomized Controlled Trial, Treatment
Brief summary
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
Detailed description
The strong relationship between posttraumatic stress disorder (PTSD) and interpersonal problems is well documented. PTSD is highly associated with relationship discord, increased intimate partner violence, and difficulties in connecting with others, leading to social isolation. These types of conflicts, as well as the social withdrawal that is common among Veterans with PTSD, diminish the Veteran's opportunities for interaction with supportive others, and serve as a barrier to successful posttraumatic adjustment. Treatments that have been rolled out nationally in VAMCs, e.g., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties. Furthermore, data show that only a limited number of Veterans has fully engaged with these interventions. Evidence-based interventions of couples therapy are available, but are not logistically feasible for many couples and do not address the problems of those who are socially isolated. This application proposes a randomized clinical trial of Interpersonal Psychotherapy (IPT-PTSD) as a treatment for Veterans with PTSD and relationship problems. Pilot data suggest that this type of treatment may provide a useful alternative strategy for Veterans who would prefer an individual, relationship-focused approach. The investigators propose comparing IPT-PTSD with Prolonged Exposure (PE), an evidence based treatment for PTSD used in the VHA system. The investigators hypothesize that IPT-PTSD will be statistically equivalent to PE in reducing PTSD symptom severity, and superior to PE in improving interpersonal functioning. IPT-PTSD is also hypothesized to be more effective than PE in improving social adjustment and quality of life. Exploratory analyses will examine whether IPT-PTSD is more effective than PE in reducing suicidal ideation, and will examine hypothesized mediators of improvement in PTSD symptoms in IPT-PTSD.
Interventions
BEHAVIORALInterpersonal Therapy for PTSD
Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.
BEHAVIORALProlonged Exposure
Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
Sponsors
Georgetown University
Southeast Louisiana Veterans Health Care System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans age 18 or older * Experienced trauma while deployed to a war zone * Meet DSM-5 criteria for PTSD and a minimum CAPS-5 score of 23 * Have at least one area of relationship dysfunction * Consent to be randomized
Exclusion criteria
* Current severe substance use disorder * Current psychotic symptoms * Current mania or un-medicated Bipolar Disorder * Imminent threat of suicide or homicide * Victim or perpetrator of severe domestic violence in the past 12 months * Currently receiving Cognitive Behavioral Therapy for PTSD * Psychotropic medication start or dosage change within the prior 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS-5) | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. |
| Change in Inventory of Interpersonal Functioning (IIP-32) | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
| Change in Concise Health Risk Tracking Scale - Total (CHRT) | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk. |
| Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome. |
| Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. |
| Change in Work and Social Adjustment Scale (WSAS) | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome. |
| Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. |
| Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. |
| GAD - 7 Generalized Anxiety Disorder | Baseline to 6 months posttreatment | Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome. |
| Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts. |
| Change in Patient Health Questionnaire (PHQ) | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks | Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IPT-PTSD Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions
Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | 58 |
| Prolonged Exposure Exposure based intervention including exposure to memories and avoided places and activities
Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | 51 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | AUD relapse | 0 | 2 |
| Overall Study | Infrequent Attendance | 2 | 1 |
| Overall Study | Legal Issue | 1 | 0 |
| Overall Study | Lost Interest | 1 | 4 |
| Overall Study | Miscellaneous Life Issues | 0 | 5 |
| Overall Study | Never Started | 3 | 3 |
| Overall Study | Other | 3 | 7 |
| Overall Study | Other Obligations | 6 | 6 |
| Overall Study | Timed Out | 2 | 0 |
Baseline characteristics
| Characteristic | Prolonged Exposure | IPT-PTSD | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 15 | 47 years STANDARD_DEVIATION 16 | 49 years STANDARD_DEVIATION 16 |
| Clinician Assessment of PTSD Symptoms Version 5 (CAPS-5) | 34.8 units on a scale STANDARD_DEVIATION 7.4 | 36.3 units on a scale STANDARD_DEVIATION 7.2 | 35.6 units on a scale STANDARD_DEVIATION 7.3 |
| Concise Health Risk Tracking (CHRT) - Propensity | 21.4 units on a scale STANDARD_DEVIATION 8.8 | 22.8 units on a scale STANDARD_DEVIATION 8.3 | 22.1 units on a scale STANDARD_DEVIATION 8.5 |
| Concise Health Risk Tracking (CHRT) Scale - Total | 25.7 units on a scale STANDARD_DEVIATION 10.4 | 27.6 units on a scale STANDARD_DEVIATION 10.3 | 26.8 units on a scale STANDARD_DEVIATION 10.3 |
| Concise Health Risk Tracking (CHRT) - Suicidal Thoughts | 4.3 units on a scale STANDARD_DEVIATION 2.4 | 4.8 units on a scale STANDARD_DEVIATION 2.6 | 4.5 units on a scale STANDARD_DEVIATION 2.5 |
| Generalized Anxiety Disorder (GAD-7) | 11.6 units on a scale STANDARD_DEVIATION 6.2 | 12.1 units on a scale STANDARD_DEVIATION 5.8 | 11.9 units on a scale STANDARD_DEVIATION 6 |
| Inventory of Interpersonal Functioning (IIP-32) | 1.43 units on a scale STANDARD_DEVIATION 0.56 | 1.53 units on a scale STANDARD_DEVIATION 0.64 | 1.48 units on a scale STANDARD_DEVIATION 0.6 |
| Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 4.6 units on a scale STANDARD_DEVIATION 1.7 | 3.9 units on a scale STANDARD_DEVIATION 1.8 | 4.2 units on a scale STANDARD_DEVIATION 1.8 |
| Multidimensional Scale of Perceived Social Support (MSPSS - Significant Other) | 5.5 units on a scale STANDARD_DEVIATION 1.2 | 4.9 units on a scale STANDARD_DEVIATION 1.9 | 5.2 units on a scale STANDARD_DEVIATION 1.6 |
| Multidimensional Scale of Perceived Support (MSPSS) - Friends | 4.1 units on a scale STANDARD_DEVIATION 1.5 | 3.9 units on a scale STANDARD_DEVIATION 1.6 | 4.0 units on a scale STANDARD_DEVIATION 1.6 |
| Patient Health Questionnaire (PHQ-9) | 13.0 units on a scale STANDARD_DEVIATION 7.3 | 15.2 units on a scale STANDARD_DEVIATION 6.4 | 14.2 units on a scale STANDARD_DEVIATION 6.9 |
| PTSD Checklist Military Version 5 (PCL-M-5) | 45.8 units on a scale STANDARD_DEVIATION 12.7 | 48.0 units on a scale STANDARD_DEVIATION 13.1 | 47.6 units on a scale STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Black | 17 Participants | 14 Participants | 31 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 31 Participants | 39 Participants | 70 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 48 Participants | 55 Participants | 103 Participants |
| WHO-QOL-BREF Item 1 Quality of Life | 3.3 units on a scale STANDARD_DEVIATION 1 | 3.1 units on a scale STANDARD_DEVIATION 0.9 | 3.2 units on a scale STANDARD_DEVIATION 1 |
| WHO-QOL-BREF Item 2 Satisfaction with Health | 2.8 units on a scale STANDARD_DEVIATION 1.2 | 2.7 units on a scale STANDARD_DEVIATION 1 | 2.8 units on a scale STANDARD_DEVIATION 1.1 |
| Work & Social Adjustment Scale (WSAS) Total | 22.6 units on a scale STANDARD_DEVIATION 9.6 | 24.0 units on a scale STANDARD_DEVIATION 8.1 | 22.8 units on a scale STANDARD_DEVIATION 8.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 54 |
| other Total, other adverse events | 0 / 61 | 0 / 54 |
| serious Total, serious adverse events | 8 / 61 | 3 / 54 |
Outcome results
Primary
Change in Clinician Administered PTSD Scale (CAPS-5)
Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Clinician Administered PTSD Scale (CAPS-5) | 3 Month Post Treatment | 27.6 score on a scale | Standard Deviation 12.4 |
| IPT-PTSD | Change in Clinician Administered PTSD Scale (CAPS-5) | Change | -8.1 score on a scale | Standard Deviation 9 |
| IPT-PTSD | Change in Clinician Administered PTSD Scale (CAPS-5) | Baseline | 36.3 score on a scale | Standard Deviation 7.2 |
| IPT-PTSD | Change in Clinician Administered PTSD Scale (CAPS-5) | End of Treatment | 27.8 score on a scale | Standard Deviation 9.8 |
| IPT-PTSD | Change in Clinician Administered PTSD Scale (CAPS-5) | 6 Month Post Treatment | 25.6 score on a scale | Standard Deviation 12.5 |
| Prolonged Exposure | Change in Clinician Administered PTSD Scale (CAPS-5) | Change | -5.5 score on a scale | Standard Deviation 11.3 |
| Prolonged Exposure | Change in Clinician Administered PTSD Scale (CAPS-5) | Baseline | 34.8 score on a scale | Standard Deviation 7.4 |
| Prolonged Exposure | Change in Clinician Administered PTSD Scale (CAPS-5) | End of Treatment | 28.2 score on a scale | Standard Deviation 13.4 |
| Prolonged Exposure | Change in Clinician Administered PTSD Scale (CAPS-5) | 3 Month Post Treatment | 26.3 score on a scale | Standard Deviation 14.7 |
| Prolonged Exposure | Change in Clinician Administered PTSD Scale (CAPS-5) | 6 Month Post Treatment | 26.3 score on a scale | Standard Deviation 14.3 |
| Difference Mean | Change in Clinician Administered PTSD Scale (CAPS-5) | 6 Month Post Treatment | -0.61 score on a scale | Standard Deviation 3.05 |
| Difference Mean | Change in Clinician Administered PTSD Scale (CAPS-5) | 3 Month Post Treatment | 1.30 score on a scale | Standard Deviation 3.16 |
| Difference Mean | Change in Clinician Administered PTSD Scale (CAPS-5) | Baseline | 1.52 score on a scale | Standard Deviation 1.4 |
| Difference Mean | Change in Clinician Administered PTSD Scale (CAPS-5) | Change | -2.56 score on a scale | Standard Deviation 2.25 |
| Difference Mean | Change in Clinician Administered PTSD Scale (CAPS-5) | End of Treatment | -0.43 score on a scale | Standard Deviation 2.57 |
Comparison: Baselinep-value: 0.28t-test, 1 sided
Comparison: End of Treatmentp-value: 0.87t-test, 1 sided
Comparison: Changep-value: 0.26t-test, 2 sided
Comparison: 3 Month Post Treatmentp-value: 0.68t-test, 1 sided
Comparison: 6 Month Follow Upp-value: 0.84t-test, 1 sided
Primary
Change in Inventory of Interpersonal Functioning (IIP-32)
Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | 4 Week | 1.5 units on a scale | Standard Deviation 0.5 |
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | Change | -0.22 units on a scale | Standard Deviation 0.57 |
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | End of Treatment | 1.33 units on a scale | Standard Deviation 0.63 |
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | Baseline | 1.53 units on a scale | Standard Deviation 0.64 |
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | 6 Month Post Treatment | 1.4 units on a scale | Standard Deviation 0.6 |
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | 3 Month Post Treatment | 1.2 units on a scale | Standard Deviation 0.6 |
| IPT-PTSD | Change in Inventory of Interpersonal Functioning (IIP-32) | 8 Week | 1.3 units on a scale | Standard Deviation 0.5 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | End of Treatment | 1.21 units on a scale | Standard Deviation 0.66 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | Baseline | 1.43 units on a scale | Standard Deviation 0.56 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | 4 Week | 1.4 units on a scale | Standard Deviation 0.7 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | 8 Week | 1.4 units on a scale | Standard Deviation 0.7 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | Change | -0.15 units on a scale | Standard Deviation 0.63 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | 3 Month Post Treatment | 1.1 units on a scale | Standard Deviation 0.6 |
| Prolonged Exposure | Change in Inventory of Interpersonal Functioning (IIP-32) | 6 Month Post Treatment | 1.1 units on a scale | Standard Deviation 0.6 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | Change | -0.06 units on a scale | Standard Deviation 0.13 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | 4 Week | 0.13 units on a scale | Standard Deviation 0.14 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | 6 Month Post Treatment | 0.24 units on a scale | Standard Deviation 0.14 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | 3 Month Post Treatment | 0.17 units on a scale | Standard Deviation 0.14 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | End of Treatment | 0.12 units on a scale | Standard Deviation 0.14 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | 8 Week | -0.12 units on a scale | Standard Deviation 0.15 |
| Difference Mean | Change in Inventory of Interpersonal Functioning (IIP-32) | Baseline | 0.11 units on a scale | Standard Deviation 0.12 |
Comparison: Baselinep-value: 0.36t-test, 1 sided
Comparison: 4-Weekp-value: 0.34t-test, 1 sided
Comparison: 8-Weekp-value: 0.43t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.09t-test, 1 sided
Comparison: End of Treatmentp-value: 0.41t-test, 1 sided
Comparison: Changep-value: 0.64t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.22t-test, 1 sided
Secondary
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity
The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | 3-Month Follow Up | 21.9 score on a scale | Standard Deviation 7.9 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Change | -2.6 score on a scale | Standard Deviation 7.3 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Baseline | 22.8 score on a scale | Standard Deviation 8.3 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | End of Treatment | 20.6 score on a scale | Standard Deviation 7.6 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | 6-Month Follow Up | 21.4 score on a scale | Standard Deviation 7.7 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Change | -3.2 score on a scale | Standard Deviation 9.3 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Baseline | 21.4 score on a scale | Standard Deviation 8.8 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | End of Treatment | 17.9 score on a scale | Standard Deviation 9.4 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | 3-Month Follow Up | 18.0 score on a scale | Standard Deviation 8.6 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | 6-Month Follow Up | 18.9 score on a scale | Standard Deviation 8.8 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | 6-Month Follow Up | 2.46 score on a scale | Standard Deviation 1.87 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | 3-Month Follow Up | 3.91 score on a scale | Standard Deviation 1.89 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Baseline | 1.40 score on a scale | Standard Deviation 1.63 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | Change | 0.64 score on a scale | Standard Deviation 1.78 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity | End of Treatment | 2.68 score on a scale | Standard Deviation 1.82 |
Comparison: Baselinep-value: 0.39t-test, 1 sided
Comparison: End of Treatmentp-value: 0.15t-test, 1 sided
Comparison: Changep-value: 0.72t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.04t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.19t-test, 1 sided
Secondary
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts
The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans missed assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | 3-Month Follow Up | 5.2 score on a scale | Standard Deviation 2.9 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Change | -0.16 score on a scale | Standard Deviation 2.33 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Baseline | 4.8 score on a scale | Standard Deviation 2.6 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | End of Treatment | 4.8 score on a scale | Standard Deviation 2.4 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | 6-Month Follow Up | 4.9 score on a scale | Standard Deviation 2.5 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Change | -0.24 score on a scale | Standard Deviation 2.83 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Baseline | 4.3 score on a scale | Standard Deviation 2.4 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | End of Treatment | 4.0 score on a scale | Standard Deviation 2.3 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | 3-Month Follow Up | 4.1 score on a scale | Standard Deviation 2 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | 6-Month Follow Up | 4.6 score on a scale | Standard Deviation 2.5 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | 6-Month Follow Up | 0.33 score on a scale | Standard Deviation 0.57 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | 3-Month Follow Up | 1.13 score on a scale | Standard Deviation 0.57 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Baseline | 0.47 score on a scale | Standard Deviation 0.48 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | Change | 0.08 score on a scale | Standard Deviation 0.55 |
| Difference Mean | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts | End of Treatment | 0.81 score on a scale | Standard Deviation 0.5 |
Comparison: Baselinep-value: 0.33t-test, 1 sided
Comparison: End of Treatmentp-value: 0.11t-test, 1 sided
Comparison: Changep-value: 0.88t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.06t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.56t-test, 1 sided
Secondary
Change in Concise Health Risk Tracking Scale - Total (CHRT)
Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Concise Health Risk Tracking Scale - Total (CHRT) | 3-Month Follow Up | 27.1 score on a scale | Standard Deviation 9.9 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Change | -2.7 score on a scale | Standard Deviation 8.9 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Baseline | 27.6 score on a scale | Standard Deviation 10.3 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale - Total (CHRT) | End of Treatment | 25.4 score on a scale | Standard Deviation 8.9 |
| IPT-PTSD | Change in Concise Health Risk Tracking Scale - Total (CHRT) | 6-Month Follow Up | 26.3 score on a scale | Standard Deviation 9.7 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Change | -3.5 score on a scale | Standard Deviation 11.3 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Baseline | 25.7 score on a scale | Standard Deviation 10.4 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale - Total (CHRT) | End of Treatment | 21.9 score on a scale | Standard Deviation 10.9 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale - Total (CHRT) | 3-Month Follow Up | 22.1 score on a scale | Standard Deviation 9.8 |
| Prolonged Exposure | Change in Concise Health Risk Tracking Scale - Total (CHRT) | 6-Month Follow Up | 23.5 score on a scale | Standard Deviation 10.3 |
| Difference Mean | Change in Concise Health Risk Tracking Scale - Total (CHRT) | 6-Month Follow Up | 2.8 score on a scale | Standard Deviation 2.27 |
| Difference Mean | Change in Concise Health Risk Tracking Scale - Total (CHRT) | 3-Month Follow Up | 5.04 score on a scale | Standard Deviation 2.28 |
| Difference Mean | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Baseline | 1.87 score on a scale | Standard Deviation 1.98 |
| Difference Mean | Change in Concise Health Risk Tracking Scale - Total (CHRT) | Change | 0.72 score on a scale | Standard Deviation 2.16 |
| Difference Mean | Change in Concise Health Risk Tracking Scale - Total (CHRT) | End of Treatment | 3.49 score on a scale | Standard Deviation 2.13 |
Comparison: Baselinep-value: 0.35t-test, 1 sided
Comparison: End of Treatmentp-value: 0.11t-test, 1 sided
Comparison: Changep-value: 0.74t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.03t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.22t-test, 1 sided
Secondary
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family
Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 3 Month Post Tx | 4.0 score on a scale | Standard Deviation 1.7 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Change | 0.34 score on a scale | Standard Deviation 1.54 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Baseline | 3.9 score on a scale | Standard Deviation 1.8 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | End of Treatment | 4.4 score on a scale | Standard Deviation 1.6 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 6 Month Post Tx | 4.5 score on a scale | Standard Deviation 1.7 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Change | 0.27 score on a scale | Standard Deviation 1.76 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Baseline | 4.6 score on a scale | Standard Deviation 1.7 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | End of Treatment | 5.1 score on a scale | Standard Deviation 1.7 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 3 Month Post Tx | 5.5 score on a scale | Standard Deviation 1.2 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 6 Month Post Tx | 5.0 score on a scale | Standard Deviation 1.8 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 6 Month Post Tx | -0.56 score on a scale | Standard Deviation 0.4 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | 3 Month Post Tx | -1.48 score on a scale | Standard Deviation 0.34 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Baseline | -0.66 score on a scale | Standard Deviation 0.33 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | Change | 0.07 score on a scale | Standard Deviation 0.36 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family | End of Treatment | -0.75 score on a scale | Standard Deviation 0.36 |
Comparison: Baselinep-value: 0.05t-test, 1 sided
Comparison: End of Treatmentp-value: 0.04t-test, 1 sided
Comparison: Changep-value: 0.86t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: <0.001t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.16t-test, 1 sided
Secondary
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends
Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | 3 Month Post Tx | 3.9 score on a scale | Standard Deviation 1.5 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Change | 0.5 score on a scale | Standard Deviation 1.6 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Baseline | 3.9 score on a scale | Standard Deviation 1.6 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | End of Treatment | 4.4 score on a scale | Standard Deviation 1.7 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | 6 Month Post Tx | 4.3 score on a scale | Standard Deviation 1.6 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Change | 0.3 score on a scale | Standard Deviation 1.8 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Baseline | 4.1 score on a scale | Standard Deviation 1.5 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | End of Treatment | 4.3 score on a scale | Standard Deviation 1.8 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | 3 Month Post Tx | 4.4 score on a scale | Standard Deviation 1.7 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | 6 Month Post Tx | 4.2 score on a scale | Standard Deviation 1.8 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | 6 Month Post Tx | 0.10 score on a scale | Standard Deviation 0.38 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | 3 Month Post Tx | -0.57 score on a scale | Standard Deviation 0.37 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Baseline | -0.23 score on a scale | Standard Deviation 0.3 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | Change | 0.20 score on a scale | Standard Deviation 0.39 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends | End of Treatment | 0.14 score on a scale | Standard Deviation 0.38 |
Comparison: Baselinep-value: 0.45t-test, 1 sided
Comparison: End of Treatmentp-value: 0.71t-test, 1 sided
Comparison: Changep-value: 0.6t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.13t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.8t-test, 1 sided
Secondary
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other
Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | 3 Month Post Tx | 4.9 score on a scale | Standard Deviation 1.7 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Change | -0.13 score on a scale | Standard Deviation 1.33 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Baseline | 4.9 score on a scale | Standard Deviation 1.9 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | End of Treatment | 4.9 score on a scale | Standard Deviation 2 |
| IPT-PTSD | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | 6 Month Post Tx | 5.2 score on a scale | Standard Deviation 1.6 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Change | -0.18 score on a scale | Standard Deviation 0.99 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Baseline | 5.5 score on a scale | Standard Deviation 1.2 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | End of Treatment | 5.7 score on a scale | Standard Deviation 1.5 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | 3 Month Post Tx | 6.0 score on a scale | Standard Deviation 1.4 |
| Prolonged Exposure | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | 6 Month Post Tx | 6.0 score on a scale | Standard Deviation 1.3 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | 6 Month Post Tx | -0.76 score on a scale | Standard Deviation 0.34 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | 3 Month Post Tx | -1.10 score on a scale | Standard Deviation 0.36 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Baseline | -0.56 score on a scale | Standard Deviation 0.31 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | Change | 0.05 score on a scale | Standard Deviation 0.27 |
| Difference Mean | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other | End of Treatment | -0.74 score on a scale | Standard Deviation 0.4 |
Comparison: Baselinep-value: 0.08t-test, 1 sided
Comparison: End of Treatmentp-value: 0.07t-test, 1 sided
Comparison: Changep-value: 0.86t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.003t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.03t-test, 1 sided
Secondary
Change in Patient Health Questionnaire (PHQ)
Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | Week 8 | 11.1 score on a scale | Standard Deviation 5.2 |
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | 6 Month | 13.2 score on a scale | Standard Deviation 6.1 |
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | Change | -3.1 score on a scale | Standard Deviation 7.5 |
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | End of Treatment | 11.8 score on a scale | Standard Deviation 6.5 |
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | Week 4 | 13.9 score on a scale | Standard Deviation 5.3 |
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | Baseline | 15.2 score on a scale | Standard Deviation 6.4 |
| IPT-PTSD | Change in Patient Health Questionnaire (PHQ) | 3 Month | 12.6 score on a scale | Standard Deviation 5.7 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | 6 Month | 11.1 score on a scale | Standard Deviation 7.2 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | Baseline | 13.0 score on a scale | Standard Deviation 7.3 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | Week 4 | 12.9 score on a scale | Standard Deviation 7.2 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | Week 8 | 11.6 score on a scale | Standard Deviation 6.9 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | End of Treatment | 10.3 score on a scale | Standard Deviation 7.1 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | Change | -2.4 score on a scale | Standard Deviation 7 |
| Prolonged Exposure | Change in Patient Health Questionnaire (PHQ) | 3 Month | 10.3 score on a scale | Standard Deviation 7.3 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | Baseline | 2.15 score on a scale | Standard Deviation 1.32 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | Change | -0.74 score on a scale | Standard Deviation 1.63 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | Week 4 | 1.0 score on a scale | Standard Deviation 1.39 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | 6 Month | 2.09 score on a scale | Standard Deviation 1.54 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | 3 Month | 2.25 score on a scale | Standard Deviation 1.51 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | End of Treatment | 1.47 score on a scale | Standard Deviation 1.51 |
| Difference Mean | Change in Patient Health Questionnaire (PHQ) | Week 8 | -0.50 score on a scale | Standard Deviation 1.52 |
Comparison: Baselinep-value: 0.11t-test, 1 sided
Comparison: 4-Weekp-value: 0.48t-test, 1 sided
Comparison: 8-Weekp-value: 0.74t-test, 1 sided
Comparison: End of Treatmentp-value: 0.34t-test, 1 sided
Comparison: Changep-value: 0.65t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.14t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.18t-test, 1 sided
Secondary
Change in PTSD Checklist for DSM-5 Military Version (PCL-M)
Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some participants skipped assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | 3-Month Follow Up | 38.4 score on a scale | Standard Deviation 17.4 |
| IPT-PTSD | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Change | -12.8 score on a scale | Standard Deviation 14 |
| IPT-PTSD | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Baseline | 48.0 score on a scale | Standard Deviation 13.1 |
| IPT-PTSD | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | End of Treatment | 33.7 score on a scale | Standard Deviation 15.9 |
| IPT-PTSD | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | 6-Month Follow Up | 36.1 score on a scale | Standard Deviation 17.9 |
| Prolonged Exposure | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Change | -11.0 score on a scale | Standard Deviation 18.8 |
| Prolonged Exposure | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Baseline | 45.8 score on a scale | Standard Deviation 12.7 |
| Prolonged Exposure | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | End of Treatment | 35.5 score on a scale | Standard Deviation 19.8 |
| Prolonged Exposure | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | 3-Month Follow Up | 36.2 score on a scale | Standard Deviation 21.2 |
| Prolonged Exposure | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | 6-Month Follow Up | 37.4 score on a scale | Standard Deviation 20 |
| Difference Mean | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | 6-Month Follow Up | -1.35 score on a scale | Standard Deviation 4.38 |
| Difference Mean | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | 3-Month Follow Up | 2.12 score on a scale | Standard Deviation 4.46 |
| Difference Mean | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Baseline | 2.15 score on a scale | Standard Deviation 2.52 |
| Difference Mean | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | Change | -1.75 score on a scale | Standard Deviation 3.69 |
| Difference Mean | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) | End of Treatment | -1.82 score on a scale | Standard Deviation 3.96 |
Comparison: Baselinep-value: 0.4t-test, 1 sided
Comparison: End of Treatmentp-value: 0.65t-test, 1 sided
Comparison: Changep-value: 0.64t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.64t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.76t-test, 1 sided
Secondary
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life
Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.
Time frame: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
Population: Some Veterans missed completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | End of Treatment | 3.2 score on a scale | Standard Deviation 0.9 |
| IPT-PTSD | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Baseline | 3.1 score on a scale | Standard Deviation 0.9 |
| IPT-PTSD | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Change | 0.04 score on a scale | Standard Deviation 0.91 |
| Prolonged Exposure | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | End of Treatment | 3.2 score on a scale | Standard Deviation 1 |
| Prolonged Exposure | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Baseline | 3.3 score on a scale | Standard Deviation 1 |
| Prolonged Exposure | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Change | -0.21 score on a scale | Standard Deviation 0.98 |
| Difference Mean | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Baseline | -0.21 score on a scale | Standard Deviation 0.18 |
| Difference Mean | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | Change | 0.25 score on a scale | Standard Deviation 0.21 |
| Difference Mean | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life | End of Treatment | 0.05 score on a scale | Standard Deviation 0.2 |
Comparison: Baselinep-value: 0.24t-test, 1 sided
Comparison: End of Treatmentp-value: 0.81t-test, 1 sided
Comparison: Changep-value: 0.24t-test, 1 sided
Secondary
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health
Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.
Time frame: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | End of Treatment | 2.6 score on a scale | Standard Deviation 1 |
| IPT-PTSD | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Baseline | 2.7 score on a scale | Standard Deviation 1 |
| IPT-PTSD | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Change | -0.12 score on a scale | Standard Deviation 1.18 |
| Prolonged Exposure | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | End of Treatment | 2.9 score on a scale | Standard Deviation 1.1 |
| Prolonged Exposure | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Baseline | 2.8 score on a scale | Standard Deviation 1.2 |
| Prolonged Exposure | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Change | 0.06 score on a scale | Standard Deviation 1.23 |
| Difference Mean | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Baseline | -0.17 score on a scale | Standard Deviation 0.21 |
| Difference Mean | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | Change | -0.18 score on a scale | Standard Deviation 0.27 |
| Difference Mean | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health | End of Treatment | -0.29 score on a scale | Standard Deviation 0.23 |
Comparison: Baselinep-value: 0.41t-test, 1 sided
Comparison: End of Treatmentp-value: 0.21t-test, 1 sided
Comparison: Changep-value: 0.5t-test, 1 sided
Secondary
Change in Work and Social Adjustment Scale (WSAS)
Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome.
Time frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Population: Some Veterans missed completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | Change in Work and Social Adjustment Scale (WSAS) | 3 Month Post Tx | 23.4 score on a scale | Standard Deviation 9.2 |
| IPT-PTSD | Change in Work and Social Adjustment Scale (WSAS) | Change | -3.5 score on a scale | Standard Deviation 9.7 |
| IPT-PTSD | Change in Work and Social Adjustment Scale (WSAS) | Baseline | 24.0 score on a scale | Standard Deviation 8.1 |
| IPT-PTSD | Change in Work and Social Adjustment Scale (WSAS) | End of Treatment | 20.4 score on a scale | Standard Deviation 10.8 |
| IPT-PTSD | Change in Work and Social Adjustment Scale (WSAS) | 6 Month Post Tx | 23.4 score on a scale | Standard Deviation 9.3 |
| Prolonged Exposure | Change in Work and Social Adjustment Scale (WSAS) | Change | -5.1 score on a scale | Standard Deviation 9.9 |
| Prolonged Exposure | Change in Work and Social Adjustment Scale (WSAS) | Baseline | 22.6 score on a scale | Standard Deviation 9.6 |
| Prolonged Exposure | Change in Work and Social Adjustment Scale (WSAS) | End of Treatment | 15.8 score on a scale | Standard Deviation 11.6 |
| Prolonged Exposure | Change in Work and Social Adjustment Scale (WSAS) | 3 Month Post Tx | 15.5 score on a scale | Standard Deviation 11.5 |
| Prolonged Exposure | Change in Work and Social Adjustment Scale (WSAS) | 6 Month Post Tx | 15.7 score on a scale | Standard Deviation 11.6 |
| Difference Mean | Change in Work and Social Adjustment Scale (WSAS) | 6 Month Post Tx | 7.73 score on a scale | Standard Deviation 2.37 |
| Difference Mean | Change in Work and Social Adjustment Scale (WSAS) | 3 Month Post Tx | 7.96 score on a scale | Standard Deviation 2.37 |
| Difference Mean | Change in Work and Social Adjustment Scale (WSAS) | Baseline | 2.40 score on a scale | Standard Deviation 1.7 |
| Difference Mean | Change in Work and Social Adjustment Scale (WSAS) | Change | 1.58 score on a scale | Standard Deviation 2.12 |
| Difference Mean | Change in Work and Social Adjustment Scale (WSAS) | End of Treatment | 4.58 score on a scale | Standard Deviation 2.41 |
Comparison: Changep-value: 0.46t-test, 1 sided
Comparison: Baselinep-value: 0.16t-test, 1 sided
Comparison: End of Treatmentp-value: 0.06t-test, 1 sided
Comparison: 3 Month Post Treatmentp-value: 0.001t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.002t-test, 1 sided
Secondary
GAD - 7 Generalized Anxiety Disorder
Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome.
Time frame: Baseline to 6 months posttreatment
Population: Some Veterans skipped completing assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | Week 4 | 12.2 score on a scale | Standard Deviation 4.9 |
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | Change | -2.3 score on a scale | Standard Deviation 5.1 |
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | End of Treatment | 9.7 score on a scale | Standard Deviation 5.7 |
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | Baseline | 12.1 score on a scale | Standard Deviation 5.8 |
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | 6 Month Follow Up | 11.0 score on a scale | Standard Deviation 5.3 |
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | 3 Month Follow Up | 11.1 score on a scale | Standard Deviation 6 |
| IPT-PTSD | GAD - 7 Generalized Anxiety Disorder | Week 8 | 9.6 score on a scale | Standard Deviation 5.5 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | End of Treatment | 9.0 score on a scale | Standard Deviation 5.8 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | Baseline | 11.6 score on a scale | Standard Deviation 6.2 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | Week 4 | 12.1 score on a scale | Standard Deviation 5.5 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | Week 8 | 10.5 score on a scale | Standard Deviation 6.4 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | Change | -2.6 score on a scale | Standard Deviation 6.3 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | 3 Month Follow Up | 9.6 score on a scale | Standard Deviation 6 |
| Prolonged Exposure | GAD - 7 Generalized Anxiety Disorder | 6 Month Follow Up | 9.2 score on a scale | Standard Deviation 5.6 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | Change | 0.25 score on a scale | Standard Deviation 1.25 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | Week 4 | 0.06 score on a scale | Standard Deviation 1.17 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | 6 Month Follow Up | 1.80 score on a scale | Standard Deviation 1.27 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | 3 Month Follow Up | 1.49 score on a scale | Standard Deviation 1.43 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | End of Treatment | 0.65 score on a scale | Standard Deviation 1.29 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | Week 8 | -0.84 score on a scale | Standard Deviation 1.53 |
| Difference Mean | GAD - 7 Generalized Anxiety Disorder | Baseline | 0.44 score on a scale | Standard Deviation 1.15 |
Comparison: Baselinep-value: 0.7t-test, 1 sided
Comparison: Week 4p-value: 0.96t-test, 1 sided
Comparison: Week 8p-value: 0.59t-test, 1 sided
Comparison: End of Treatmentp-value: 0.61t-test, 1 sided
Comparison: Changep-value: 0.84t-test, 1 sided
Comparison: 3 Month Follow Upp-value: 0.3t-test, 1 sided
Comparison: 6 Month Post Treatmentp-value: 0.16t-test, 1 sided