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Testing implementation of Cognitive Behavioral Therapy- Promoting Resilience and Support for Mental Health (CBT-PRISM)

Equity-focused implementation of LGBTQ-affirmative cognitive behavioral therapy: a hybrid implementation-effectiveness trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15258280
Enrollment
12
Registered
2025-10-13
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Access to tailored evidence-based treatment for depression and self-injurious thoughts or behaviors among U.S. military veterans who identify as LGBTQ+. Mental and Behavioural Disorders

Interventions

Facilities are randomized using constrained randomization to one of two implementation arms: 1) Standard Implementation Package, or 2) Enhanced Implementation Package. The Standard Implementation Pack

Sponsors

Veterans Health Administration
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Facility (primary participants, unit of randomization) Inclusion Criteria: 1. Availability and willingness of one internal implementation facilitator (devoting up to 3 hours/week for 18 months) 2. Site leadership (Chief of Staff or Associate Chief of Staff for Mental and Behavioral Health Services) is willing to sign an agreement confirming willingness for the internal facilitator, trainers, and facility training, and (if randomized to the Enhanced Condition) willing to interact with study personnel for at least one meeting. 3. In the event that more than 12 facilities apply for inclusion in the study, inclusion will be prioritized by several factors, including number of Mental Health Service full-time employees (to ensure sufficient sample size of clinicians), representativeness across facility complexity classifications, and representativeness across rural/urban locations. Provider Electronic Health Record Cohort Inclusion Criteria (not enrolled): 1. Non-specialty practicing psychotherapist at included study facility 2. Delivered psychotherapy within the measurement period Patient Electronic Health Record Cohort Inclusion (not enrolled): 1. Identified as LGBTQ+ using validated natural language processing algorithm from electronic health record notes from 2019 to present.

Exclusion criteria

Exclusion criteria: Facility-Level Exclusion Criteria (primary participants, unit of randomization): 1. Facility using Cerner as its electronic health record system 2. Internal Facilitator not available 3. Facility leadership unwilling to support implementation Provider Electronic Health Record Cohort Exclusion Criteria (not enrolled): 1. Not a practicing psychotherapist at an included study facility 2. Did not deliver psychotherapy within the measurement period Patient Electronic Health Record Cohort Exclusion (not enrolled): 1. Not identified as LGBTQ+ using validated natural language processing algorithm from electronic health record notes from 2019 to present.

Design outcomes

Primary

MeasureTime frame
The extent to which an Enhanced Implementation Package improves the adoption and sustainment of the evidence-based psychotherapy (provider-level main outcomes) is measured through the following variables: 1. Primary Adoption Outcome, defined as the rate of practicing psychotherapists delivering at least one session of CBT-PRISM measured using electronic health record data from patients within the healthcare system in the 18-month Implementation Period. 2. Primary Sustainment Outcome, defined as the rate of practicing psychotherapists delivering at least one session of CBT-PRISM measured using electronic health record data from patients within the healthcare system in the 6-month Sustainment Period

Secondary

MeasureTime frame
1. Reach Outcome: Receiving CBT-PRISM, defined as the proportion of LGBTQ+ veterans with electronic health record depression diagnosis receiving at least one session of CBT-PRISM across implementation arms, measured using electronic health record data from patients within the healthcare system during the 18-month Implementation Period and during the 6-month Sustainment Period. 2. Effectiveness Outcome: Documentation of clinically significant improvement in depression symptoms, defined as the proportion of LGBTQ+ veterans with an electronic health record depression diagnosis with a clinically significant decrease in depression symptoms, measured pragmatically using electronic health record data from health system patients. Clinically significant change on health system symptom measurement tools (Patient Health Questionnaire-9; PHQ-9) will be quantified using the Reliable Change Index during the 18-month Implementation Period and 6-month Sustainment Period. 3. Effectiveness Outcome: Likelihood of having documented self-injurious thoughts or behaviors, measured pragmatically using electronic health record data of health care system patients, adjusting for pre-implementation levels of self-injurious thoughts or behaviors.

Countries

United States of America

Contacts

Public ContactHollis Weidenbacher
hollis.weidenbacher@va.gov1-919-286-0411 ext. 17-7377

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026