Clinical trial NCT06162741: Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Official title: Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This study seeks to further test the effectiveness of Primary Care Brief Mindfulness Training (PCBMT) across multiple geographically distinct VHA primary care settings that serve diverse Veteran populations and begin to understand important implementation factors with a hybrid type I randomized controlled trial in 300 primary care patients with psychological distress. The study aims include comparing PCBMT to a transdiagnostic problem solving group (Moving Forward, MF) on clinical outcomes, testing mediators and moderators of treatment gain in PCBMT and MF, and assessing implementation barriers and facilitators to inform future implementation efforts. The investigators hypothesize that Veterans randomized to PCBMT will experience larger decreases in psychological distress than participants randomized to MF and changes in transdiagnostic processes will mediate the relationship between changes in mindfulness and psychological distress.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:

* 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.

Primary outcomes:
measure: Depression Anxiety and Stress Scale (DASS-21) Change
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Secondary outcomes:
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Other outcomes:
measure: Screening measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Enrollment/Baseline (0 Weeks)
measure: Screening measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Enrollment/Baseline (0 Weeks)
measure: Screening Measure: Blessed Orientation Memory & Concentration Test (BOMC)
timeFrame: Enrollment/Baseline (0 Weeks)
measure: Screening Measure: P4 Screener
timeFrame: Enrollment/Baseline (0 Weeks)
measure: Five Facet Mindfulness Questionnaire (FFMQ-15)
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
measure: White Bear Suppression Inventory (WBSI)
timeFrame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
measure: The Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE)
timeFrame: Enrollment/Baseline (0 weeks)
measure: Demographics and Military Background Questionnaire
timeFrame: Enrollment/Baseline (0 weeks)
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System, Phoenix, AZ
state: Arizona
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: Syracuse VA Medical Center, Syracuse, NY
name: Kyle Possemato, PhD
role: PRINCIPAL_INVESTIGATOR
References: