Three-Principles Approach for Incarcerated Adults

September 28, 2022 updated by: Sarah Bowen, Pacific University

Establishing Preliminary Efficacy of Three Principles Correctional Counseling in a Prison Sample

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prevailing correctional counseling methods (e.g., cognitive-behavior therapy, social learning) often operate from an "outside-in" paradigm attempting to put mental health "into" people in prison using various strategies and techniques. Three Principles Correctional Counseling (3PCC), informed by theosophy of Sydney Banks, with a subsequent intervention based on Banks's work, is grounded in a different paradigm-in which all individuals, including incarcerated, have innate positive mental health; however, their belief systems convince them otherwise. When incarcerated individuals learn to navigate daily challenges with mental clarity, affective states shift from negative to positive, allowing for state-dependent positive recall, leading to lower likelihood of responding to negative thoughts and feelings with deviant and other health-damaging behavior.

Studies suggest 3PCC leads to improvements in negative affect such as depression, anxiety, and rumination, and increases in positive outcomes including mindfulness, mental health, social well-being, emotional regulation and non-attachment in non-correctional samples, reductions in stress and anxiety for HIV-positive patients; improvements in substance use problems, criminal justice involvement, employment, housing, and psychological wellbeing for women in in-patient substance abuse treatment; improved resilience in high-risk children and adolescents, improved mental health and resilience in young trauma-exposed sex offenders, improvements in thought recognition, mindfulness, and psychological well-being in a correctional sample, and improved in mental well-being, purpose in life, anxiety and anger, and behavior in a UK prison. 3PCC has also shown feasibility and acceptability in refugee women with trauma, and demonstrated feasible retention rates of 76% in an English prison setting.

The current trial is designed to further assess efficacy of 3PCC in incarcerated individuals. 3PCC classes will be facilitated by practitioners with several years of experience working with diverse client populations. Each 3PCC class will meet weekly for 10 consecutive weeks, with each session approximately 3 hours long. Classes will include the following modules: Building Rapport, Exploration of "Reality"; Separate Realities; Exploration of Thought and Insight; Consciousness-Where Does it Come From?; Exploring Feelings/Moods/Behavior; Exploring Innate Health/Natural Intelligence; What is Mind?; Exploring Infinite Potential; Exploring Mental Clarity Versus a Busy Mind; Stepping into the Unknown, Implications of the Principles for Life in Prison; and Living Outside of Prison.

Hypothesis 1: Compared with the control group, participants in the 3PCC condition will demonstrate significant increases in psychological flexibility, quality of life, clear mind, emotional regulation, impulse control and purpose in life at post-course, which will be maintained at 3- and 6-month follow-up.

Hypothesis 2: Compared with the control group, participants exposed to 3PCC will show significant decreases in depression, anxiety, anger, and trauma symptoms at post-course, which will be maintained at 3- and 6-month follow-up.

Hypothesis 3: Compared with the control group, participants exposed to 3PCC will show greater improvement in behavior within the prison community at post-course, which will be maintained at 3- and 6-month follow-up. Behavior will be measured by prison records measuring participants' behavioral violations and rewards for prosocial behavior.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Hillsboro, Oregon, United States, 97123
        • Pcific University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants receiving Three-Principles Counseling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Psychological Flexibility and Experiential Avoidance across 6 months
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, Post-intervention (10 weeks after Pre-intervention), 3 months and 6 months following Post-intervention
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
Time Frame: Pre-intervention, and 6 months following Post-intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Post-intervention (10 weeks after Pre-intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacific University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1206211-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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