NCT07167719

Brief Summary

This pilot study assesses the feasibility and acceptability of delivering a brief Cognitive-Behavioral Resiliency treatment to a population of recently released parolees. This study will also give a preliminary indication if the treatment is associated with reliable improvements in adjustment symptoms and well-being for parolees.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

September 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 5, 2026

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 4, 2025

Last Update Submit

February 3, 2026

Conditions

Keywords

IncarcerationReentry

Outcome Measures

Primary Outcomes (3)

  • Adjustment Disorder New Module 20

    The ADNM-20 is a self-report measure consisting of two parts: a stressor list and an item list. It is a 20-item measure that ranges from 20 to 80. Participants will fill out stressors from their prison term and will then complete the items which are composed of a 4-point Likert scales from "Never" to "Often."

    From pretreatment (baseline) to the end of treatment (5 weeks after baseline)

  • Flourishing Scale

    The Flourishing Scale is an 8-item self-report measure (with a range of 8 to 56) of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score.

    From pretreatment (baseline) to the end of treatment (5 weeks after baseline)

  • PROMIS Meaning and Purpose Short Form 8a

    The PROMIS Meaning and Purpose is an 8-item self-report measure with a range of 8 to 40 that assess one's sense of life having purpose and that there are good reasons for living. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.

    From pretreatment (baseline) to the end of treatment (5 weeks after baseline)

Secondary Outcomes (1)

  • PTSD Checklist 5

    From pretreatment (baseline) to the end of treatment (5 weeks after baseline)

Study Arms (2)

Treatment

EXPERIMENTAL

Participants will receive a 5-session CBT intervention

Behavioral: Cognitive Behavioral Therapy

Assessment Only

NO INTERVENTION

Participants will receive study assessments

Interventions

Brief Cognitive-Behavioral Therapy (CBT) focused on building resiliency in response to the effects of institutionalization

Also known as: CBT
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Speaks English
  • Been on parole for two years or less.
  • Score of 8.5 or higher (range 4 to 16) on the Adjustment Disorder New Module 4 (ADNM-4) screening tool (Ben-Ezra, et al., 2018).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Francisco Homes

Los Angeles, California, 90037, United States

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Emily Owens

    University of California, Irvine

    STUDY DIRECTOR

Central Study Contacts

Joanne B DeCaro

CONTACT

Alyson K Zalta

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study employees two arms: the treatment arm and an assessment only arm. The pilot study is non-randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 11, 2025

Study Start

January 27, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 5, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is a small sample size and the study participant's are a systemically vulnerable population.

Locations