PTSD Treatment for Incarcerated Men and Women

NCT03891797 | Completed

• 3 other identifiers: 2018-0630A538900SMPH/PSYCHIATRY/PSYCHIATRY
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

There is a particular need for more effective treatments for post-traumatic stress disorder (PTSD) within the incarcerated population. The prevalence of trauma history and PTSD are markedly higher in jail and prison populations than in the general population, with estimates of current PTSD prevalence among prison inmates exceeding 20%, as opposed to 3-6% in the general population. Cognitive Processing Therapy (CPT) is a potentially promising PTSD treatment for the prison setting. The primary objectives of this project include:

1. 1.Establish the feasibility of group CPT delivery in male and female prisons with PTSD by examining participant retention in the 12-week course;
2. 2.Obtain preliminary efficacy estimates for reducing PTSD symptom severity, as well as secondary symptoms associated with trauma, including depression, hopelessness, self-blame, and negative self-related thoughts.

Conditions

PTSD

Outcome Measures

Primary Outcomes (8)

• PTSD-Checklist-5 (PCL-5)

  The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Participants rate on a 0 ("not at all") - 4 ("Extremely") scale how bothered they have been by PTSD symptoms in the last month. Total scores range from 0-80.

  4 months

• Eligibility

  Percentage of inmates who meet the full set of inclusion criteria.

  3 months

• Participation

  Percentage of eligible inmates agreeing to participate in randomization into one of the two groups.

  4 months

• Retention

  Percentage of inmates attending all 12 sessions.

  12 weeks

• Compliance

  Compliance will be measured in three ways: Percentage of retained inmates performing intervention activities during session (e.g., attending to and contributing to the discussion); the percentage of inmates completing the homework assignment each week; and the percentage of inmates fully completing the pre-, mid-, and post-intervention assessment batteries. All three measures of compliance will be reported individually. An overall metric of compliance will be calculated by averaging the three individual measures.

  4 months

• Adherence

  Adherence will by measured by the presence or absence of five session elements (scores 0-5) by the clinical supervisors, as in previous CPT studies.

  12 weeks

• Competence

  Ratings of the quality of session elements (scores 1-7; 1="not satisfactory", 4="satisfactory", 7="excellent") by the clinical supervisors, as in previous CPT studies

  12 weeks

• Safety-Suicidal ideation item on the Beck Depression Inventory-II (BDI-II)

  The BDI-II is a 21-item self-report questionnaire assessing symptoms of depression in the last 2-weeks. Each item is on a 0-3 scale, with higher scores indicative of greater symptom severity. Scores range from 0-63.

  4 months

Secondary Outcomes (3)

• Posttraumatic Cognition Inventory (PCTI)

  4 months

• Beck Hopelessness Scale (BHS)

  4 months

• Beck Depression Inventory (BDI-II)

  4 months

Study Arms (2)

Cognitive Processing Therapy

EXPERIMENTAL

12 sessions of group-based Cognitive Processing Therapy administered 1x/week for 90 minutes each session.

Other: Cognitive Processing Therapy

Control

NO INTERVENTION

No treatment/treatment as usual. Participants will complete questionnaires at three time points with no intervention.

Interventions

Cognitive Processing Therapy OTHER

Group-based psychotherapy.

Also known as: CPT

Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM 5 criteria for current PTSD diagnosis
• IQ greater than 70
• Reading level of 5th grade or higher
• No history of psychosis or dementia
• Stable medication use (same medication for at least one month) if using medication
• No scheduled transfer or release for at least 12 weeks (the duration of the intervention).

You may not qualify if:

• Other vulnerable populations within the prison setting will not be eligible for participation, such as:
• pregnant women
• individuals who have English as a second language
• those with visual or hearing impairments
• individuals appearing to lack the capacity to provide informed consent

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Fox Lake Correctional Institute

Fox Lake, Wisconsin, 53933, United States

Location

Related Publications (9)

• Goff A, Rose E, Rose S, Purves D. Does PTSD occur in sentenced prison populations? A systematic literature review. Crim Behav Ment Health. 2007;17(3):152-62. doi: 10.1002/cbm.653.

  PMID: 17595672 BACKGROUND

• Egeressy A, Butler T, Hunter M. 'Traumatisers or traumatised': Trauma experiences and personality characteristics of Australian prisoners. Int J Prison Health. 2009;5(4):212-22. doi: 10.1080/17449200903343209.

  PMID: 25757522 BACKGROUND

• Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.

  PMID: 15939839 BACKGROUND

• Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.

  PMID: 7492257 BACKGROUND

• Kilpatrick DG, Resnick HS, Milanak ME, Miller MW, Keyes KM, Friedman MJ. National estimates of exposure to traumatic events and PTSD prevalence using DSM-IV and DSM-5 criteria. J Trauma Stress. 2013 Oct;26(5):537-47. doi: 10.1002/jts.21848.

  PMID: 24151000 BACKGROUND

• Elbogen EB, Johnson SC, Wagner HR, Sullivan C, Taft CT, Beckham JC. Violent behaviour and post-traumatic stress disorder in US Iraq and Afghanistan veterans. Br J Psychiatry. 2014;204(5):368-75. doi: 10.1192/bjp.bp.113.134627. Epub 2014 Feb 27.

  PMID: 24578444 BACKGROUND

• Campbell CA, Albert I, Jarrett M, Byrne M, Roberts A, Phillip P, Huddy V, Valmaggia L. Treating Multiple Incident Post-Traumatic Stress Disorder (PTSD) in an Inner City London Prison: The Need for an Evidence Base. Behav Cogn Psychother. 2016 Jan;44(1):112-7. doi: 10.1017/S135246581500003X. Epub 2015 Feb 20.

  PMID: 25697197 BACKGROUND

• Heckman CJ, Cropsey KL, Olds-Davis T. Posttraumatic stress disorder treatment in correctional settings: A brief review of the empirical literature and suggestions for future research. Psychotherapy (Chic). 2007 Mar;44(1):46-53. doi: 10.1037/0033-3204.44.1.46.

  PMID: 22122167 BACKGROUND

• Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael Koenigs, PhD

  UW-Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 5, 2019
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)