PTSD
Conditions
Keywords
Group therapy, Incarcerated Individuals
Brief summary
Study examining the feasibility of and psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of 10 individuals for CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.
Detailed description
Overall Study Objectives: The primary objectives of this project include: 1. Establish the feasibility of group CPT delivery in male and female incarcerated populations with PTSD; 2. Establish the acceptability of group CPT delivery in male and female incarcerated populations with PTSD; 3. Establish feasibility of assessment collection for primary outcome measures, secondary outcome measures, and potential mediators and moderators during a clinical trial examining group CPT delivery in incarcerated settings. Prior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system. Potential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent. Eligible participants will first complete the Clinician-Administered PTSD Scale for DSM-5 (PCL-5) to ascertain current PTSD symptomology and diagnosis. Participants will then be assigned to the CPT groups. The CPT groups will engage in 12, 90-minute treatment sessions (18 hours total). CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 6 participants will be included in each CPT session. Participants will be notified via institutional mail when they are starting CPT. Participants will be able to continue any ongoing treatment/interventions they are engaged in within the institution. All participants will be asked what treatment groups they are currently enrolled in during the initial screening to examine the possibility of attentional bias within the CPT group (i.e., more frequent interaction leading to treatment outcomes). In addition to the treatment groups, CPT group members will also complete a pre-treatment testing session two weeks prior to treatment week 1. After treatment session 5, group members will complete mid-testing assessments. Participants will be called down individually to complete these assessments in a private room with a research assistant after completing the 5th therapy session, but before completing the 8th therapy session. CPT group members will then complete post-treatment testing within one week after completing treatment (group session 12). One month after the treatment is completed, group members will complete the first round of follow-up testing. Three months after the treatment is completed, group members will complete the final round of follow-up testing. Post- and one-month follow up- testing will follow the same procedure as pre- and mid-testing. The three month follow-up session will be identical, with the addition of the PCL-5 interview to re-assess PTSD diagnosis. Group members will be asked to complete 18 sessions in total (pre-, mid-, post-, one-month follow-up testing, three month follow-up testing, 12 treatment groups, and 1 post-intervention focus group).
Interventions
CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups.
Sponsors
Study design
Intervention model description
Participants are assigned to CPT therapy-intervention group.
Eligibility
Inclusion criteria
* Intelligence quotient (IQ) greater than or equal to 70 * 18 years old or older * Reading level of 4th grade or higher * stable medication use (same medication for at least one month) * able and willing to participate in group therapy * meet PCL-5 criteria for a current PTSD diagnosis within two months of study enrollment * no scheduled release date before the end of the treatment group
Exclusion criteria
* currently enrolled in trauma focused treatment that is historical or involves processing of trauma itself * no active symptoms of psychosis that would interfere with the individual's ability to participate in the group * no active suicidal ideation with intent or plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions | up to 6 weeks (by the end of 12th session) | Intervention feasibility measured primarily by participant retention |
| Change in Self-reported PTSD Symptoms (PCL-5) | baseline (one week prior to intervention), post-intervention (up to 13 weeks on study) | PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period. |
| Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) | Post (1 week post-intervention, up to 13 weeks on study) | Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets | By the end of final treatment session (up to 12 weeks) | Assesses for participant compliance: extent to which participants complied with treatment skill practice |
| Percentage of Session Elements That Were Rated Present (Versus Absent) by a Clinical Supervisor | By the end of final treatment session (up to 12 weeks) | Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated. |
| Percentage of Individuals That Meet Study Inclusion Criteria | baseline (one week prior to intervention) | Assesses for participant eligibility as secondary measure of intervention feasibility. |
| Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) | post (one week post-intervention, up to 13 weeks on study) | Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility. |
| Reasons for Participant Discontinuation | Up to 3 month follow up (up to 25 weeks) | We will collect information on participant dropout reasons to understand reasons for discontinuation |
| Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | By the end of final treatment session (up to 12 weeks) | Higher ratings indicate higher-quality session element (scores 1-5; 1=poor, 5=excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility. |
| Percentage of Eligible Individuals Enrolled in the Study | up to start of intervention | Assesses for participant interest as secondary measure of intervention feasibility. |
| Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) | By the end of final treatment session (up to 12 weeks) | Assesses for participant compliance: participation during session as secondary measure of intervention feasibility. |
Countries
United States
Participant flow
Pre-assignment details
89 participants were consented, 79 were deemed eligible, 69 started group.
Participants by arm
| Arm | Count |
|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) Group Arm = Cognitive Processing Therapy (CPT) Group = Women's Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups. | 35 |
| Men's Facility Cognitive Processing Therapy (CPT) Arm = Cognitive Processing Therapy (CPT)
Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Left Facility | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
| Overall Study | Withdrawn by Therapist | 1 | 1 |
Baseline characteristics
| Characteristic | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Age, Continuous | 36.09 years STANDARD_DEVIATION 10.78 | 39.6 years STANDARD_DEVIATION 11.3 | 38.12 years STANDARD_DEVIATION 11.23 |
| Beck Anxiety Inventory (BAI) | 22.57 score on a scale STANDARD_DEVIATION 9.72 | 25.03 score on a scale STANDARD_DEVIATION 9.32 | 23.72 score on a scale STANDARD_DEVIATION 9.54 |
| Beck Depression Inventory 2 (BDI-II) | 30.14 score on a scale STANDARD_DEVIATION 11.41 | 29.94 score on a scale STANDARD_DEVIATION 9.17 | 30.04 score on a scale STANDARD_DEVIATION 10.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 32 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PCL-5 | 50.49 units on a scale STANDARD_DEVIATION 12.29 | 47.26 units on a scale STANDARD_DEVIATION 10.31 | 48.90 units on a scale STANDARD_DEVIATION 11.39 |
| Race (NIH/OMB) Womens Facility American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Womens Facility Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Womens Facility Black or African American | 3 Participants | 14 Participants | 17 Participants |
| Race (NIH/OMB) Womens Facility More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Womens Facility Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Womens Facility Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Womens Facility White | 28 Participants | 17 Participants | 45 Participants |
| Region of Enrollment United States | 35 participants | 34 participants | 69 participants |
| Sex: Female, Male Female | 35 Participants | 0 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 34 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 7 / 35 | 14 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Change in Self-reported PTSD Symptoms (PCL-5)
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.
Time frame: baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)
Population: Participants with baseline and post-intervention data - the negative numbers indicate a decrease in symptom severity of the intervention period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Change in Self-reported PTSD Symptoms (PCL-5) | -19.07 score on a scale |
| Men's Facility Cognitive Processing Therapy (CPT) | Change in Self-reported PTSD Symptoms (PCL-5) | -12.94 score on a scale |
Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)
Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame: Post (1 week post-intervention, up to 13 weeks on study)
Population: Participants lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) | 28.48 units on a scale | Standard Deviation 3.93 |
| Men's Facility Cognitive Processing Therapy (CPT) | Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) | 25.7 units on a scale | Standard Deviation 4.74 |
Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions
Intervention feasibility measured primarily by participant retention
Time frame: up to 6 weeks (by the end of 12th session)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions | 31 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions | 32 Participants |
Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)
Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.
Time frame: By the end of final treatment session (up to 12 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) | 31 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) | 30 Participants |
Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II)
Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility.
Time frame: post (one week post-intervention, up to 13 weeks on study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) | 0 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) | 2 Participants |
Percentage of Eligible Individuals Enrolled in the Study
Assesses for participant interest as secondary measure of intervention feasibility.
Time frame: up to start of intervention
Population: Eligible participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Percentage of Eligible Individuals Enrolled in the Study | 35 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Percentage of Eligible Individuals Enrolled in the Study | 34 Participants |
Percentage of Individuals That Meet Study Inclusion Criteria
Assesses for participant eligibility as secondary measure of intervention feasibility.
Time frame: baseline (one week prior to intervention)
Population: Screened participants (one week prior to intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Percentage of Individuals That Meet Study Inclusion Criteria | 43 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Percentage of Individuals That Meet Study Inclusion Criteria | 36 Participants |
Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets
Assesses for participant compliance: extent to which participants complied with treatment skill practice
Time frame: By the end of final treatment session (up to 12 weeks)
Population: Retained participants (up to 12 weeks on study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets | 21 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets | 22 Participants |
Percentage of Session Elements That Were Rated Present (Versus Absent) by a Clinical Supervisor
Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated.
Time frame: By the end of final treatment session (up to 12 weeks)
Population: CPT session elements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Percentage of Session Elements That Were Rated Present (Versus Absent) by a Clinical Supervisor | 87.72 Percentage of session elements present |
| Men's Facility Cognitive Processing Therapy (CPT) | Percentage of Session Elements That Were Rated Present (Versus Absent) by a Clinical Supervisor | 85.96 Percentage of session elements present |
Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist
Higher ratings indicate higher-quality session element (scores 1-5; 1=poor, 5=excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.
Time frame: By the end of final treatment session (up to 12 weeks)
Population: Both unique and non-unique but essential items were analyzed. Unique Items = therapeutic tasks specific to delivery of CPT; Essential Items = therapeutic tasks not specific to CPT but essential to the therapeutic process
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | Unique Items | 4.67 CPT session elements | Standard Deviation 0.57 |
| Women's Facility Cognitive Processing Therapy (CPT) | Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | Essential Items | 4.77 CPT session elements | Standard Deviation 0.43 |
| Men's Facility Cognitive Processing Therapy (CPT) | Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | Unique Items | 4.35 CPT session elements | Standard Deviation 0.5 |
| Men's Facility Cognitive Processing Therapy (CPT) | Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | Essential Items | 4.36 CPT session elements | Standard Deviation 0.53 |
Reasons for Participant Discontinuation
We will collect information on participant dropout reasons to understand reasons for discontinuation
Time frame: Up to 3 month follow up (up to 25 weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Transferred Facilities | 1 Participants |
| Women's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Scheduling Issues | 1 Participants |
| Women's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Group Not Helpful | 1 Participants |
| Women's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Work | 0 Participants |
| Women's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Withdrawn by study clinician | 0 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Withdrawn by study clinician | 2 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Work | 2 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Scheduling Issues | 0 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Transferred Facilities | 0 Participants |
| Men's Facility Cognitive Processing Therapy (CPT) | Reasons for Participant Discontinuation | Group Not Helpful | 0 Participants |