An interventional study of Healing Trauma Plus (HT+): A Brief Intervention for Women and Gender-Diverse People in Trauma-related PTSD, Anxiety and Distress and Depression, sponsored by Envisioning Justice Solutions, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Envisioning Justice Solutions, Inc · Not applicable, Interventional, and Treatment
This randomized controlled trial evaluated Healing Trauma Plus (HT+), a brief, manualized, trauma-specific intervention designed for justice-involved women and transgender and gender-diverse individuals. The six-session curriculum uses psychoeducation, cognitive-behavioral strategies, mindfulness, grounding techniques, and structured exercises to help participants understand trauma, manage trauma-related distress, and develop coping skills.
The study was conducted at a California correctional facility and compared participants randomly assigned to HT+ with participants assigned to a waitlist control condition. The program was delivered by trained peer facilitators in general institutional housing and the reception center, and by an external HT+ Program Coordinator in administrative segregation.
Researchers assessed changes in trauma-related distress and behavioral health symptoms using validated self-report measures administered before and after the intervention period. The study examined between-group differences in post-traumatic stress symptoms, global trauma symptoms, anxiety, depression, dissociation, sexual abuse-related trauma symptoms, and sleep disturbances.
Healing Trauma Plus (HT+) is a brief, manualized, trauma-specific intervention developed for women and gender-diverse people. The curriculum addresses the effects of childhood and adult victimization through psychoeducation, cognitive-behavioral strategies, mindfulness, grounding techniques, expressive exercises, and guided imagery. Its six structured sessions address understanding trauma, exploring traumatic experiences, the relationship between thoughts, feelings, and actions, guilt, shame and anger, healthy relationships, and love and endings.
This randomized controlled trial evaluated HT+ among participants at a California correctional facility across multiple housing and security classifications, including the reception center, general institutional population, and administrative segregation.
A total of 256 participants were randomized to HT+ (n = 112) or a parallel waitlist control condition (n = 144). Assignment was determined by the final digit of each participant's California Department of Corrections and Rehabilitation (CDCR) identification number, using a prespecified allocation rule established by a coin toss. Participants with even-numbered final digits were assigned to HT+, and participants with odd-numbered final digits were assigned to waitlist control.
The intervention consisted of six structured group sessions. Trained peer facilitators delivered HT+ in general institutional housing and the reception center. In administrative segregation, where custody policies restricted peer access, an external HT+ Program Coordinator delivered the curriculum. Groups in general housing and the reception center consisted of six to ten participants.
Participants completed self-report assessments at baseline and at post-assessment. The assessment battery included the modified Short Screening Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) post-traumatic stress disorder (PTSD), the Trauma Symptom Checklist-40 (TSC-40), the Generalized Anxiety Disorder-7 (GAD-7), and the Patient Health Questionnaire-9 (PHQ-9). Outcomes included post-traumatic stress symptoms, global trauma-related distress, anxiety, depression, dissociation, sexual abuse-related trauma symptoms, and sleep disturbances.
The study received human subjects protection approval from Solutions Institutional Review Board (IRB) on May 26, 2023, and administrative approval from the California Department of Corrections and Rehabilitation Research Oversight Committee on July 11, 2023. Recruitment and data collection began in August 2023 and concluded in June 2025.
The research was supported by the California Department of Corrections and Rehabilitation through the California Reentry \& Enrichment Programming Grants, Agreement Number C5611000.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 256 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Envisioning Justice Solutions, Inc as lead sponsor.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria: All participants who expressed interest in participating in the study at the California women's prison and who were capable of providing written .
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Exclusion Criteria: There were no study-defined exclusion criteria; operational exclusions or security restrictions were at the discretion of prison administration.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the six-session, manualized Healing Trauma Plus (HT+) intervention.
Behavioral: Healing Trauma Plus (HT+): A Brief Intervention for Women and Gender-Diverse People
Participants assigned to the waitlist control condition, who served as the comparison group during the study. Participants were offered Healing Trauma Plus (HT+) after their study participation.
Healing Trauma Plus (HT+) is a brief, manualized, trauma-specific intervention designed specifically for individuals who have experienced trauma associated with ACEs and adult victimization. The curriculum emphasizes psychoeducation, awareness, and behavioral health skill-building, specifically introducing grounding techniques and mindfulness frameworks to help participants manage trauma-conditioned distress and hyperarousal. The program architecture consists of six structured sessions: (1) The Subject of Trauma; (2) Exploring Trauma; (3) Thinking, Feeling, and Acting; (4) Beyond Guilt, Shame, and Anger; (5) Healthy Relationships; and (6) Love and Endings. Materials include a manualized Facilitator's Guide and an integrated Participant's Workbook utilized for in-session group exercises, journaling, and homework.
Change in post-traumatic stress symptoms
Change in scores on the modified Short Screening Scale for DSM-IV PTSD, a 7-item self-report measure assessing the frequency of post-traumatic distress symptoms over the preceding four weeks. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in global trauma-related distress
Change in the total composite score on the Trauma Symptom Checklist-40 (TSC-40), a 40-item self-report measure of trauma-related symptoms. Total scores range from 0 to 120. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in generalized anxiety
Changes in generalized anxiety manifestation using the Patient Health Questionnaire Anxiety Subscale. Total scores range from 0 - 18. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in depression
Changes in depressive symptomatology was operationalized utilizing the Patient Health Questionnaire Depression Subscale (PHQ-9). Total scores range from 0 - 27. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in trauma-related anxiety
Change in trauma-related anxiety was measured on the Trauma Symptom Checklist-40 (TSC-40), a 40-item self-report measure of trauma-related symptoms. Total scores on the anxiety subscale range from 0 to 27. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in trauma-related depression
Change in trauma-related depression was measured on the Trauma Symptom Checklist-40 (TSC-40), a 40-item self-report measure of trauma-related symptoms. Total scores on the depression subscale range from 0 to 27. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in trauma-related sleep disturbance symptoms
Change in trauma-related sleep disturbance symptoms was measured on the Trauma Symptom Checklist-40 (TSC-40), a 40-item self-report measure of trauma-related symptoms. Total scores on the sleep disturbance symptoms subscale range from 0 to 18. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in trauma-related dissociation
Change in trauma-related Dissociation was measured on the Trauma Symptom Checklist-40 (TSC-40), a 40-item self-report measure of trauma-related symptoms. Total scores on the Dissociation subscale range from 0 to 18. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Change in Sexual Abuse Trauma Index
Change in Sexual Abuse Trauma Index was measured on the Trauma Symptom Checklist-40 (TSC-40), a 40-item self-report measure of trauma-related symptoms. Total scores on the Sexual Abuse Trauma Index subscale range from 0 to 21. Change scores were calculated as baseline score minus post-assessment score.
Time frame: Baseline to post-assessment; mean interval 12.27 weeks (SD 2.80 weeks).
Plan to share: No — Individual participant data will not be shared because sharing is subject to applicable data-use restrictions and authorization from the California Department of Corrections and Rehabilitation (CDCR).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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