Innovative treatments for the recovery implementation program
| ISRCTN | ISRCTN16144716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16144716 |
| electronic Research Administration (eRA) Commons application number | 1I50HX004145 |
| Project ID | QUE 25-011 |
| Sponsor | Quality Enhancement Research Initiative |
| Funder | Quality Enhancement Research Initiative |
- Submission date
- 04/12/2025
- Registration date
- 16/12/2025
- Last edited
- 12/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression and posttraumatic stress disorder (PTSD) are debilitating conditions with immeasurable social and economic costs, affecting the lives of hundreds of millions of people annually. Unfortunately, current treatment options for these conditions are often inadequate to meet Veterans’ needs. Therefore, innovative evidence-based treatment options are needed to improve Veteran experience, outcomes, and mental health services.
This project will implement innovative evidence-based treatments for trauma-related conditions and treatment-resistant depression that improve Veteran care by addressing VA priorities of suicide prevention, outcomes, access, whole health, quality, value, and efficiency. The study involves the implementation of two evidence-based practices (EBP): 1) Mantram Repetition Program, a meditation-based approach to reduce PTSD symptoms, and 2) Ketamine Therapy for treatment-resistant depression and suicidality.
The study aims to first work with clinicians, operational staff, and Veterans to understand local needs and challenges so strategies can be tailored for successful and lasting implementation of evidence-based practices (EBPs). Next, it will introduce two EBPs at 16 sites using a stepped-wedge design and a set of support activities, including assessments, workshops, training, and facilitation. Finally, the study will evaluate how well the EBPs perform using RE-AIM measures (Reach, Effectiveness, Adoption, Implementation, and Maintenance), assess cost-effectiveness, and identify factors that help or hinder success. It will also create practical resources, such as playbooks, workshops, and training, to support long-term sustainability and wider adoption across the system.
Who can participate?
VHA medical facilities that want to implement the Mantram Repetition Program and/or Ketamine Therapy.
What does the study involve?
Using two randomly allocated studies, the EBPs will be implemented across sites to improve multiple high-priority quality/impact domains guided by the Practical Robust Implementation and Sustainability Model (PRISM). A novel implementation strategy will be used to bundle 1) iterative PRISM assessment (iPRISM), 2) Modified Rapid Process Improvement Workshops (RPIW), 3) training, and 4) Implementation facilitation. The impact of the two EBPs will be evaluated using multiple data sources as well as analytical methods. Quantitative and qualitative data will be collected longitudinally across pre-implementation, implementation, and sustainment, which will include survey, interview, adaptation, engagement, economic, and service outcome data.
What are the possible benefits and risks of participating?
While there is no direct benefit to participation in this study, the project hopes to identify and enhance best practices for mental health treatment for Veterans and to learn how best to implement cutting-edge clinical care programs.
Potential risks associated with participation in the study are 1) loss of confidentiality and 2) feeling discomfort answering survey/interview questions during participation. Such risks are not likely and would not lead to serious consequences.
Where is the study run from?
VA San Diego Healthcare System in San Diego, USA.
When is the study starting and how long is it expected to run for?
January 2026 to September 2030.
Who is funding the study?
The VA Quality Enhancement Research Initiative (QUERI), USA.
Who is the main contact?
Dr James Pittman, PhD, LCSW, James.Pittman@va.gov
Contact information
Public, Scientific, Principal investigator
3350 La Jolla Village Drive
La Jolla
92161
United States of America
| Phone | +1 (858)-750-9246 |
|---|---|
| James.Pittman@va.gov |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Uncontrolled | |
| Assignment | Sequential | |
| Purpose | Health services research | |
| Scientific title | Innovative Treatments for Recovery Implementation Program: a randomized quality improvement program implementing innovative evidence-based treatments for Veterans with trauma related conditions and treatment resistant depression to improve care by addressing VA priorities of suicide prevention, clinical outcomes, access, whole health, quality, value, and efficiency. | |
| Study objectives | 1) Pre-implementation: Engage clinical, operational, and Veteran partners to gather perspectives on local context to optimize strategies for the implementation and sustainability of the Mantram Repetition Program (MRP) and Ketamine Therapy (KT). 2) Implementation: Implement these two evidence-based practices (EBP) across 16 sites using two cluster randomized stepped-wedge design studies and a multicomponent implementation strategy bundle (i.e. iPRISM Assessment, Rapid Process Improvement Workshops [RPIW], training, and facilitation). 3) Sustainment: Evaluate RE-AIM outcomes (i.e., Reach, Effectiveness, Adoption, Implementation, and Maintenance) aligned with national performance quality standards, as well as the cost-effectiveness of the EBPs. Identify key multi-level contextual facilitators and barriers for their implementation and sustainment using the Practical Robust Implementation and Sustainability Model (PRISM) and a mixed-method analytic approach. Develop sustainment and scale-up capacity for the EBPs by creating multilevel strategies and products (e.g., playbooks, workshops, trainings) for each EBP to support enterprise dissemination and uptake. | |
| Ethics approval(s) | Ethics approval not required | |
| Health condition(s) or problem(s) studied | Implementation of evidence-based treatments for posttraumatic stress disorder and treatment-resistant depression. | |
| Intervention | These studies are part of a multicenter step-wedged hybrid type-2 implementation effectiveness mixed-methods quality improvement program. VA implementation partners are involved in the implementation of the Mantram Repetition Program (MRP) or Ketamine Therapy (KT) at one of the project sites. The two interventions administered in this study are the MRP and KT. There is no control treatment for this quality improvement project. Sites will be randomized by implementation start date. 1. Mantram Repetition Program (MRP). Mantram repetition consists of the silent repetition of a self-selected word or short phrase with spiritual meaning multiple times throughout the day. Mantram repetition is used to develop one-pointed attention, increase present moment awareness, regulate emotions, and manage distressing thoughts. The MRP is a transdiagnostic intervention, with documented positive effects on a range of outcomes, including reductions in post-traumatic stress disorder (PTSD) symptoms. The MRP can be taught in person or virtually, including by use of pre-recorded videos or by clinicians or paraprofessional; and can even be done via self-guided software application. MRP can be delivered in individual or group-based formats, typically involving a 60-minute meeting; and has been successfully delivered in 1-8 sessions. MRP is provided on an outpatient basis. For this QUERI program, MRP will be tailored to meet the unique needs of each implementation site. Background and further details on Mantram Repetition can be found here: https://www.jillbormann.com/mantram-repetition-program 2. Ketamine Therapy (KT). KT has been shown to have rapid antidepressant effects in multiple research trials, which has led to the FDA-approval as an intervention for treatment-resistant depression (TRD). The medication is administered intravenously, intramuscularly, or intranasally in a face-to-face medical appointment with qualified health providers in a range of dosages that vary in rate, length, and frequency. KT can be given in an inpatient or outpatient setting. For this project, KT will be customized to each site depending on the unique needs of each. Background and further details on KT can be found here: https://www.va.gov/formularyadvisor/DOC_PDF/CRE_Ketamine_Infusion_for_Treatment_Resistant_Depression_Rev_Oct_2025.pdf | |
| Intervention type | Mixed | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
PRISM Contextual Survey Instrument and Qualitative Interviews at pre-implementation, implementation, and sustainment timepoints. Adaptation Tracking as indicated by adaptation events and cost analysis at implementation and sustainment timepoints. | |
| Completion date | 30/09/2030 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Key inclusion criteria | 1. Frontline staff 2. Clinicians 3. Operational partners 4. Supervisors/managers/leaders |
| Key exclusion criteria | Must meet all inclusion criteria and accept the invitation to participate in the program by the study principal investigator |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 01/04/2030 |
Locations
Countries of recruitment
- United States of America
Study participating centre
San Diego
92161
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
12/12/2025: Study’s existence confirmed by the US Department of Veterans Affairs, USA.
