Testing implementation of Cognitive Behavioral Therapy- Promoting Resilience and Support for Mental Health (CBT-PRISM)
| ISRCTN | ISRCTN15258280 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15258280 |
| Secondary identifying numbers | CIRB 1781791 |
- Submission date
- 01/10/2025
- Registration date
- 13/10/2025
- Last edited
- 09/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Veterans who are lesbian, gay, bisexual, queer/questioning, trans, and other related identities (LGBTQ+) have disproportionate risk for poor mental health outcomes and suicide. LGBTQ+ veterans face unique barriers to accessing care. Tailored cognitive behavioral therapy has a strong evidence base for improving mental health among LGBTQ+ individuals. This evidence-based psychotherapy (EBP) is ready for use, but it has not yet been implemented widely in VHA. This EBP was adapted as CBT-PRISM (Cognitive Behavioral Therapy - Promoting Resilience and Support for Mental Health) in the current study to meet the unique needs of LGBTQ+ Veterans who receive care through VHA. The objective of this project is to use an implementation-effectiveness trial design to test provider- and Veteran-level outcomes linked with an Enhanced Implementation Package to increase adoption and sustainment of CBT-PRISM. The study includes the following specific aims: 1) To refine an Enhanced Implementation Package for improving uptake of CBT-PRISM; 2a) To conduct a multi-site randomly allocated trial of 12 facilities comparing a Standard Implementation Package to an Enhanced Implementation Package; 2b) To qualitatively examine determinants of implementation across sites through provider and patient interviews; and 3) To estimate the number of patients reached and effectiveness of the Enhanced Implementation Package between the two arms of the study.
Who can participate?
Twelve Veterans Health Administration facilities that meet the inclusion criteria and are selected may participate in the study.
What does the study involve?
This trial includes 12 facilities equally randomly allocated to receive either a Standard Implementation Package (internal facilitation, live virtual training for clinicians, free therapist treatment manuals, and clinical consultation/community of practice) or an Enhanced Implementation Package (Standard Implementation plus 6 implementation strategies focused on Veteran-centered health equity). The primary implementation outcome is adoption, as measured by the rate of psychotherapists delivering at least one session of CBT-PRISM. Effectiveness outcomes include clinically significant change in depression (primary) and likelihood of self-injurious thoughts or behaviors (secondary).
What are the possible benefits and risks of participating?
Enhanced implementation strategies may help better integrate social drivers of health into daily operations. Please note that this is a hybrid type III implementation-effectiveness trial. Hence, delivery of the evidence-based psychotherapy (CBT-PRISM) within treatment sessions is not part of the study protocol.
Where is the study run?
The primary site running the study is the Durham Veterans Affairs Health Care System in Durham, NC, USA.
When is the study starting and how long is it expected to run for?
Activities with randomized facilities begin 01 Oct 2025. Clinician training in CBT-PRISM begins 01 Feb 2026, with an anticipated start for clinicians delivering the CBT-PRISM to patients on or after 01 Apr 2026. The active implementation period with facilities will run until 01 Apr 2027, and the sustainment period with facilities will run until 01 Oct 2027.
Who is funding the study?
The Department of Veterans Affairs, Health Services Research & Development, USA.
Who is the main contact?
Sarah M. Wilson, PhD, Principal Investigator, sarah.m.wilson@va.gov
Contact information
Scientific, Principal investigator
VA Durham Health Care, Veterans Affairs
508 Fulton St
Durham
27705
United States of America
 ORCID ID |
0000-0002-1028-6028 |
|---|---|
| Phone | +1-919-286-0411 ext. 17-7914 |
| sarah.m.wilson@va.gov |
Public
VA Durham Health Care, Veterans Affairs
508 Fulton St.
Durham
27705
United States of America
| ORCID ID |
0000-0002-8108-4204 |
|---|---|
| Phone | 1-919-286-0411 ext. 17-7377 |
| hollis.weidenbacher@va.gov |
Study information
| Study design | Hybrid Type III implementation effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Equity-focused implementation of LGBTQ-affirmative cognitive behavioral therapy: a hybrid implementation-effectiveness trial |
| Study acronym | DELVE |
| Study objectives | The objective of this project is to use a hybrid type III implementation-effectiveness trial design to test provider- and Veteran-level outcomes associated with an Enhanced Implementation Package aimed at increasing the adoption and sustainment of CBT-PRISM (Cognitive Behavioral Therapy - Promoting Resilience and Support for Mental Health). The study includes the following specific aims: 1) to refine an Enhanced- Implementation Package for improving uptake of CBT-PRISM; 2a) To conduct a multi-site cluster-randomized trial of 12 facilities comparing a Standard Implementation Package to an Enhanced Implementation Package; 2b) To examine determinants of implementation across sites qualitatively; and 3) To estimate the reach and effectiveness of the Enhanced Implementation Package among LGBTQ+ Veterans between implementation arms. |
| Ethics approval(s) |
Approved 19/04/2025, Department of Veterans Affairs, VA Central Institutional Review Board (810 Vermont Avenue, NW ORD 14RD, Washington, DC, 20420, United States of America; 800-698-2411; VACentralIRB@va.gov), ref: 24-12 |
| Health condition(s) or problem(s) studied | Access to tailored evidence-based treatment for depression and self-injurious thoughts or behaviors among U.S. military veterans who identify as LGBTQ+. |
| Intervention | Facilities are randomized using constrained randomization to one of two implementation arms: 1) Standard Implementation Package, or 2) Enhanced Implementation Package. The Standard Implementation Package includes the following strategies: internal facilitation, live virtual training for clinicians, free therapist treatment manuals, and clinical consultation/community of practice. The Enhanced Implementation Package includes all strategies from the Standard Implementation Package in addition to the following strategies: process to build infrastructure support, external facilitation to build within-organization and local community interrelationships, local CBT-PRISM referral champions, internal facilitator learning collaborative, and electronic health record audit and feedback of treatment delivery. Both implementation packages will be delivered across an 18-month Implementation Period. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/08/2024 |
| Completion date | 30/07/2028 |
Eligibility
| Participant type(s) | Patient, Employee, Other |
|---|---|
| Age group | Adult |
| Sex | All |
| Target number of participants | 12 facilities |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 01/04/2027 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Durham
27705
United States of America
Sponsor information
Government
810 Vermont Ave NW
Washington DC
20571
United States of America
| Phone | +1-800- 827-1000 |
|---|---|
| VAResearch@va.gov | |
| Website | https://www.va.gov/health/ |
"ROR" |
https://ror.org/05eq41471 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- Department of Veterans Affairs, United States Department of Veterans Affairs, US Department of Veterans Affairs, U.S. Dept. of Veterans Affairs, Veterans Affairs, Veterans Affairs Department, VA, USDVA
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed scientific journals, and to share findings with VA leadership and Veteran service organizations. |
| IPD sharing plan | There are no plans to share non-aggregate data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 09/10/2025 | No | No |
Additional files
Editorial Notes
02/10/2025: Study's existence confirmed by the Department of Veterans Affairs, VA Central Institutional Review Board.
