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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04747704
Other study ID # 1206211-5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2018
Est. completion date June 30, 2022

Study information

Verified date September 2022
Source Pacific University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to examine the feasibility, acceptability and preliminary efficacy of an acceptance-based, insight-oriented treatment approach for US incarcerated adults. Feasibility and acceptability will be assessed through attendance and retention throughout the intervention period. Primary outcomes include negative affect, psychological flexibility, emotion regulation, purpose in life, impulsivity, and trauma. Changes will be assessed from baseline to post-course, post-course to 6-month follow up, and baseline to 6-month follow up for all primary outcomes. Researchers hypothesize that, 1) retention rates will be similar to previous trials with 70% retention from pre- to post-course; 2) there will be significant baseline-to-post-course reductions in psychological symptoms, impulsivity, and trauma, and an increase in psychological flexibility, purpose in life, and emotion regulation; and 3) there will be significant baseline-to-6-month reductions in psychological symptoms, impulsivity, and trauma, and an increase in psychological flexibility, purpose in life, and emotion regulation.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Three Principles Counseling
A 10-week insight-based program offered in prisons in a group setting for 2 hours each week. Approximately 15 - 20 adults or youth in custody participate at a time, led by two trained teachers. The curriculum is designed to teach an understanding of the mind and human experience for the purpose of reducing risk factors, uncovering resiliency and to promote emotional and psychological well-being for adults and youth in the criminal justice system. This is taught through a compilation of sessions that speak to the potential, ability and resilience inherent in every individual. Sessions include a mix of lessons, experiential learning, and group conversations.

Locations

Country Name City State
United States Pcific University Hillsboro Oregon

Sponsors (1)

Lead Sponsor Collaborator
Pacific University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Psychological Flexibility and Experiential Avoidance across 6 months The Acceptance and Action Questionnaire-II (Bond et al., 2011) is a self-report measure of experiential avoidance and psychological inflexibility. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Wellbeing across 6 months Short Form 36 (SF-36) is a self-report measure assessing health-related quality of living. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Emotion Regulation across 6 months The DERS-18 is a brief, 18-item self-report questionnaire designed to assess multiple aspects of emotional dysregulation (Victor & Klonsky, 2016). Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Purpose in Life across 6 months The PILT is a 20-item self-report attitude scale, which measures the extent to which people perceive their lives to be purposeful and meaningful. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Trauma symptoms across 6 months The PTSD Checklist - Civilian version (PCL-C; Weathers et al., 1994) is a 17-item self-report, diagnostic screening instrument assessing criteria for PTSD. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Impulsivity across 6 months The Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking scale (UPPS; Whiteside & Lynam, 2001) is a self-report, 45-item inventory to measure four distinct personality pathways to impulsive behavior. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Depression across 6 months PROMIS Depression-Short Form (PR-Dep; PROMIS Health Organization) is an 8-item self-report measure assessing depression based on DSM-5 symptomatology. Respondents report the degree to which they have been bothered by each symptom during the past 7 days. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Anxiety across 6 months The PROMIS Anxiety-Short Form (PR-Anx; PROMIS Health Organization) is a 7-item self-report measure assessing anxiety based on DSM-5 symptomatology. Respondents report the degree to which they have been bothered by each symptom during the past 7 days. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Anger across 6 months The PROMIS Anger-Short Form (PR-Ang; PROMIS Health Organization) is a 5-item self-report scale measuring anger based on DSM-5 symptomatology. Respondents reported the degree to which they have been bothered by each symptom during the past 7 days. Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
Primary Change in Prosocial and Non-Prosocial Behavior across 6 months Prison records regarding participants' behavioral violations and rewards for pro-social behavior will provide data on prosocial and Non-Prosocial behaviors. Pre-intervention, and 6 months following Post-intervention
Secondary Acceptability The Course Satisfaction Survey will be given out upon completion of the group (along with the post-intervention assessments) as a means of collecting qualitative data about what the participants felt they can take away from the group. Post-intervention (10 weeks after Pre-intervention)
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