Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans

NCT06162741 | Recruiting DMC

• 2 other identifiers: IIR 22-0131I01HX003626-01A2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and/or PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and/or PTSD and increase overall functioning.

Conditions

Post Traumatic Stress Disorder (PTSD); Depression; Anxiety

Keywords

Psychological Distress; Post Traumatic Stress Disorder (PTSD); Mindfulness; Primary Care; Brief Intervention; Depression; Anxiety; Problem-solving training

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety and Stress Scale (DASS-21) Change

  The Depression Anxiety and Stress Scale (DASS-21) is a widely used measurement for psychological symptoms and distress. It consists of 21 items measured on a 4-point scale. The three subscale scores for depression, anxiety, and stress are also valid measures of their constructs and will be used as secondary outcomes. Depression subscale range: 0-42 with higher scores meaning a worse outcome. Anxiety subscale range: 0-42 with higher scores meaning a worse outcome. Stress subscale range 0-21 with higher scores indicative of greater symptom severity.

  Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks

Secondary Outcomes (2)

• Satisfaction with Life Scale (SWLS)

  Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks

• PTSD Checklist for DSM-5 (PCL-5)

  Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks

Other Outcomes (10)

• Screening measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Enrollment/Baseline (0 Weeks)

• Screening measure: Patient Health Questionnaire (PHQ-9)

  Enrollment/Baseline (0 Weeks)

• Screening Measure: Blessed Orientation Memory & Concentration Test (BOMC)

  Enrollment/Baseline (0 Weeks)

Study Arms (2)

Primary Care Brief Mindfulness Training (PCBMT)

EXPERIMENTAL

PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.

Behavioral: Primary Care Brief Mindfulness Training (PCBMT)

Moving Forward (MF)

ACTIVE COMPARATOR

Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act".

Behavioral: Moving Forward (MF)

Interventions

Primary Care Brief Mindfulness Training (PCBMT) BEHAVIORAL

PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). It was developed by Dr. Scott Treatman and Dr. Dessa Bergen-Cico (Co-I). PCBMT consists of four 90-minute classes (360 total minutes of classes). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. In-class meditations are followed by a group process of the experience. At-home practice between sessions is encouraged and is guided by simple checklists asking students to check the meditation they practiced and write a few comments about what the experience was like.

Also known as: PCBMT

Primary Care Brief Mindfulness Training (PCBMT)

Moving Forward (MF) BEHAVIORAL

Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act". The format that will be used as the comparison is manualized, group-delivered, primary care-based, often co-delivered by MH providers and peers, and considered a usual care practice in many VHA PCMHI programs. MF content is derived from problem solving therapy, which has clear effectiveness in reducing depression and other types of psychological distress. While the MF manual consists of four 60-minutes classes, for this study the 4 classes will be 90-minutes long to equate the length of both conditions. No new content will be added rather the additional time will be used to allow Veterans to complete worksheets in class and allow more group discussion.

Also known as: MF

Moving Forward (MF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible, participants must be:
• enrolled in VA primary care through the local VA site
• report clinically significant psychological distress as measured in at least one of three areas:
• PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor
• depression operationalized as 10 on the PHQ-9
• anxiety operationalized by 10 on the GAD-7

You may not qualify if:

• gross cognitive impairment
• suicide attempt or desire to commit suicide in the last month
• To allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:
• had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled
• had a change in psychiatric medication outside of VHA primary care in the last 2 months
• voice a preference to be directly referred to specialty mental health care
• Veterans with mild TBI, and alcohol/ substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

RECRUITING

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106-1621, United States

RECRUITING

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kyle Possemato, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Possemato, PhD

CONTACT

(315) 425-4400; kyle.possemato@va.gov

Ariella Davis

CONTACT

Ariella.Davis@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be enrolled in one of the two intervention groups at the end of the baseline. Research staff enrolling and administering assessments to the participants will be blinded to which intervention a participant is randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants in the study are assigned to one of two treatment arms, Primary Care Brief Mindfulness Training (PCBMT) or Moving Forward (MF) transdiagnostic problem-solving therapy, at the beginning of the trial and continue in that arm throughout the length of the trial. Randomization will occur towards the end of the baseline session, at the individual level, at a 1:1 ratio of assignment to PCBMT or MF. Study participants are only exposed to the treatment that is assigned to the particular study arm they are enrolled in.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: August 19, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after completion of the study.
• Access Criteria: Final, de-identified datasets will be made available upon PI request for validation purposes, meta analyses and other similar purposes.

Locations

US (4)