NCT04747704

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

3.7 years

First QC Date

February 1, 2021

Last Update Submit

September 28, 2022

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Acceptability

    Post-intervention (10 weeks after Pre-intervention)

Study Arms (1)

Intervention

EXPERIMENTAL

Participants receiving Three-Principles Counseling

Behavioral: Three Principles Counseling

Interventions

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.

Intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 9 months left in their sentence
  • agree to complete assessments at baseline, post-course, and 3 and 6 months following completion of the 3PCC course
  • are able to read and write in English.

You may not qualify if:

  • DOC staff deems it inappropriate for them to participate in the study for clinical or administrative reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pcific University

Hillsboro, Oregon, 97123, United States

Location

MeSH Terms

Conditions

Recidivism

Condition Hierarchy (Ancestors)

Criminal BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 10, 2021

Study Start

October 18, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations