Psychological DistressNCT04747704
Three-Principles Approach for Incarcerated Adults
A study testing Three Principles Counseling in people with Psychological Distress and Recidivism, run by Pacific University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Recidivism
- What is being tested?
- Three Principles Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- DOC staff deems it inappropriate for them to participate in the study for clinical or administrative reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Distress, Recidivism
- Being tested
- Three Principles Counseling
- Medical subject headings
- Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three Principles CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receiving Three-Principles Counseling Receives: Behavioral: Three Principles Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention, and 6 months following Post-intervention
Secondary outcomes (1)
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.
Measured: Post-intervention (10 weeks after Pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start18 Oct 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Bowen, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747704
- Sponsor's protocol ID
- 1206211-5
- Status last verified
- Sep 2022
- First submitted
- 1 Feb 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Preliminary Efficacy of Three Principles Correctional Counseling in a Prison Sample
- ClinicalTrials.gov ID
- NCT04747704
- Acronym / sponsor ID
- 1206211-5
- Conditions
- Psychological Distress, Recidivism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Three Principles CounselingParticipants receiving Three-Principles Counseling |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- DOC staff deems it inappropriate for them to participate in the study for clinical or administrative reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three Principles CounselingA 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. | Behavioural | Intervention |
Primary outcome
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Acceptability
Time frame: Post-intervention (10 weeks after Pre-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three Principles Counseling in people with Psychological Distress and Recidivism, run by Pacific University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.