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PTSD Treatment for Incarcerated Men and Women: NIMH

PTSD Treatment for Incarcerated Men and Women: NIMH

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05168267
Enrollment
69
Registered
2021-12-23
Start date
2022-06-06
Completion date
2024-07-31
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

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

BEHAVIORALCognitive 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants are assigned to CPT therapy-intervention group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessionsup 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

MeasureTime frameDescription
Percentage of Retained Participants That Completed at Least >80% of Assigned WorksheetsBy 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 SupervisorBy 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 Criteriabaseline (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 DiscontinuationUp 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 TherapistBy 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 Studyup to start of interventionAssesses 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

ArmCount
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
Total69

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLeft Facility10
Overall StudyWithdrawal by Subject21
Overall StudyWithdrawn by Therapist11

Baseline characteristics

CharacteristicWomen's Facility Cognitive Processing Therapy (CPT) GroupMen's Facility Cognitive Processing Therapy (CPT)Total
Age, Continuous36.09 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 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants32 Participants67 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
PCL-550.49 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 Participants0 Participants2 Participants
Race (NIH/OMB)
Womens Facility
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Womens Facility
Black or African American
3 Participants14 Participants17 Participants
Race (NIH/OMB)
Womens Facility
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Womens Facility
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Womens Facility
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Womens Facility
White
28 Participants17 Participants45 Participants
Region of Enrollment
United States
35 participants34 participants69 participants
Sex: Female, Male
Female
35 Participants0 Participants35 Participants
Sex: Female, Male
Male
0 Participants34 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 34
other
Total, other adverse events
7 / 3514 / 34
serious
Total, serious adverse events
0 / 350 / 34

Outcome results

Primary

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.

ArmMeasureValue (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
Primary

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

ArmMeasureValue (MEAN)Dispersion
Women's Facility Cognitive Processing Therapy (CPT)Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)28.48 units on a scaleStandard Deviation 3.93
Men's Facility Cognitive Processing Therapy (CPT)Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)25.7 units on a scaleStandard Deviation 4.74
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women's Facility Cognitive Processing Therapy (CPT)Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions31 Participants
Men's Facility Cognitive Processing Therapy (CPT)Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions32 Participants
Secondary

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)

ArmMeasureValue (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
Secondary

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)

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women's Facility Cognitive Processing Therapy (CPT)Percentage of Eligible Individuals Enrolled in the Study35 Participants
Men's Facility Cognitive Processing Therapy (CPT)Percentage of Eligible Individuals Enrolled in the Study34 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women's Facility Cognitive Processing Therapy (CPT)Percentage of Individuals That Meet Study Inclusion Criteria43 Participants
Men's Facility Cognitive Processing Therapy (CPT)Percentage of Individuals That Meet Study Inclusion Criteria36 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women's Facility Cognitive Processing Therapy (CPT)Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets21 Participants
Men's Facility Cognitive Processing Therapy (CPT)Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets22 Participants
Secondary

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

ArmMeasureValue (NUMBER)
Women's Facility Cognitive Processing Therapy (CPT)Percentage of Session Elements That Were Rated Present (Versus Absent) by a Clinical Supervisor87.72 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 Supervisor85.96 Percentage of session elements present
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Women's Facility Cognitive Processing Therapy (CPT)Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by TherapistUnique Items4.67 CPT session elementsStandard Deviation 0.57
Women's Facility Cognitive Processing Therapy (CPT)Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by TherapistEssential Items4.77 CPT session elementsStandard Deviation 0.43
Men's Facility Cognitive Processing Therapy (CPT)Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by TherapistUnique Items4.35 CPT session elementsStandard Deviation 0.5
Men's Facility Cognitive Processing Therapy (CPT)Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by TherapistEssential Items4.36 CPT session elementsStandard Deviation 0.53
Secondary

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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Women's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationTransferred Facilities1 Participants
Women's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationScheduling Issues1 Participants
Women's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationGroup Not Helpful1 Participants
Women's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationWork0 Participants
Women's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationWithdrawn by study clinician0 Participants
Men's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationWithdrawn by study clinician2 Participants
Men's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationWork2 Participants
Men's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationScheduling Issues0 Participants
Men's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationTransferred Facilities0 Participants
Men's Facility Cognitive Processing Therapy (CPT)Reasons for Participant DiscontinuationGroup Not Helpful0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026