Post-Traumatic Stress Disorder
Conditions
Keywords
Trauma, Psychotherapy, Anxiety
Brief summary
This study will examine whether interpersonal psychotherapy is as effective in treating post-traumatic stress disorder as the established therapies of prolonged exposure and relaxation.
Detailed description
Post-traumatic stress disorder (PTSD) is caused by a traumatic experience often involving physical harm or the threat of harm or death. The emotional numbness and traumatic flashbacks symptomatic of PTSD interfere with everyday life for approximately 7.7 million adults. Besides prescription drug treatment, only exposure-based therapies, like prolonged exposure (PE) therapy, have been proved effective in treating PTSD. Interpersonal psychotherapy (IPT), which is not based on exposure, is effective in treating mood disorders, and pilot studies indicate it may also be effective in treating PTSD. IPT treats patients by helping them to improve their interpersonal functioning, as opposed to PE, which helps patients by guiding them to recreate traumatic memories in safe circumstances. This study will determine whether IPT is as effective as PE, the gold standard, in treating PTSD. Relaxation therapy, a commonly used control therapy for studies of PTSD, will be used for that purpose here. All participants will be screened for PTSD, with those meeting the criteria being randomly assigned to one of the following three treatment groups: * Group 1 participants will receive IPT. They will meet weekly for fourteen 50-minute sessions focusing on interpersonal consequences of the trauma affecting them and their relationships with others. * Group 2 participants will receive PE. They will meet for 10, unevenly spaced 90-minute sessions during which they will face the trauma responsible for their symptoms. * Group 3 participants will receive relaxation therapy. They will meet for nine 90-minute sessions and one 30-minute session during which they will learn relaxation methods. All treatments will last 14 weeks, with assessments made by mental health professionals at screening, the midpoint of the study, the end of the study, and a 3-month follow-up. PTSD symptoms will be assessed through clinical interviews and self-report measures. In addition, participants will complete other interviews and tests that will examine a variety of factors relating to mental health, including comorbidity of other conditions, affect, social functioning, and quality of life.
Interventions
BEHAVIORALInterpersonal Psychotherapy
14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
BEHAVIORALProlonged Exposure Therapy
Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
BEHAVIORALRelaxation Therapy
Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial of three time-limited (14 week) psychotherapies for unmedicated patients with chronic posttraumatic stress disorder (PTSD)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for primary, chronic PTSD * At least moderately severe symptoms, defined by a minimum total (frequency plus severity) Clinician-Administered PTSD Scale score greater than 50 * Willing to undergo an independent clinical assessment and other ratings
Exclusion criteria
* Diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders * Psychiatric disorder due to a general medical condition * Current substance abuse or dependence * Acute suicide or homicide risk * Unstable or life-threatening medical condition * Primary diagnosis of borderline personality disorder, major depressive disorder, or major depression, melancholic subtype * Diagnosis of antisocial personality disorder * At least partial benefit from current treatment regimen * Unwillingness to discontinue current ineffective psycho- or pharmacotherapy * Inability to speak or read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | After 14 weeks of treatment | Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores \>50 indicate at least moderately severe PTSD; scores \<20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | After 14 weeks of treatment | Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores \<8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Interpersonal Psychotherapy (IPT) Participants will receive interpersonal psychotherapy.
Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports | 40 |
| 2 Prolonged Exposure (PE) Participants will receive prolonged exposure therapy.
Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma | 38 |
| 3 Relaxation Therapy Participants will receive relaxation therapy.
Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD | 32 |
| Total | 110 |
Baseline characteristics
| Characteristic | 1 Interpersonal Psychotherapy (IPT) | Total | 3 Relaxation Therapy | 2 Prolonged Exposure (PE) |
|---|---|---|---|---|
| Age, Continuous | 38.12 Years STANDARD_DEVIATION 11.21 | 40.10 Years STANDARD_DEVIATION 11.57 | 40.62 Years STANDARD_DEVIATION 11.48 | 41.76 Years STANDARD_DEVIATION 11.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 31 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 79 Participants | 21 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 19 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 10 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 72 Participants | 19 Participants | 22 Participants |
| Region of Enrollment United States | 40 participants | 110 participants | 32 participants | 38 participants |
| Sex: Female, Male Female | 28 Participants | 77 Participants | 28 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 33 Participants | 4 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 38 | 0 / 32 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 | 0 / 32 |
Outcome results
Primary
Clinician-Administered PTSD Scale (CAPS)
Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores \>50 indicate at least moderately severe PTSD; scores \<20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156
Time frame: After 14 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Interpersonal Psychotherapy (IPT) | Clinician-Administered PTSD Scale (CAPS) | Baseline | 68.9 units on a scale | Standard Deviation 16.2 |
| 1 Interpersonal Psychotherapy (IPT) | Clinician-Administered PTSD Scale (CAPS) | Week 14 | 39.8 units on a scale | Standard Deviation 24.3 |
| 2 Prolonged Exposure (PE) | Clinician-Administered PTSD Scale (CAPS) | Baseline | 72.1 units on a scale | Standard Deviation 18.2 |
| 2 Prolonged Exposure (PE) | Clinician-Administered PTSD Scale (CAPS) | Week 14 | 37.5 units on a scale | Standard Deviation 28.8 |
| 3 Relaxation Therapy | Clinician-Administered PTSD Scale (CAPS) | Baseline | 68.9 units on a scale | Standard Deviation 16.4 |
| 3 Relaxation Therapy | Clinician-Administered PTSD Scale (CAPS) | Week 14 | 46.5 units on a scale | Standard Deviation 31 |
Secondary
Hamilton Depression Rating Scale
Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores \<8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62
Time frame: After 14 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Interpersonal Psychotherapy (IPT) | Hamilton Depression Rating Scale | Baseline | 18.3 units on a scale | Standard Deviation 6.5 |
| 1 Interpersonal Psychotherapy (IPT) | Hamilton Depression Rating Scale | Week 14 | 13.8 units on a scale | Standard Deviation 8.8 |
| 2 Prolonged Exposure (PE) | Hamilton Depression Rating Scale | Baseline | 20.2 units on a scale | Standard Deviation 6.7 |
| 2 Prolonged Exposure (PE) | Hamilton Depression Rating Scale | Week 14 | 12.3 units on a scale | Standard Deviation 8.8 |
| 3 Relaxation Therapy | Hamilton Depression Rating Scale | Baseline | 21.0 units on a scale | Standard Deviation 7.1 |
| 3 Relaxation Therapy | Hamilton Depression Rating Scale | Week 14 | 14.8 units on a scale | Standard Deviation 9.1 |