Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
enrolled in VA primary care through the local VA site
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
Disqualifiers
gross cognitive impairment
suicide attempt or desire to commit suicide in the last month
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
Trial design
Design model
Parallel
Treatments tested in this trial
Primary Care Brief Mindfulness Training (PCBMT)
BehavioralPCBMT 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.
Moving Forward (MF)
BehavioralMoving 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Primary Care Brief Mindfulness Training (PCBMT)Experimental treatment 1 intervention
Group B: Moving Forward (MF)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeksSecondary outcomes
1
Satisfaction with Life Scale (SWLS)
Satisfaction with Life Scale (SWLS) is a 5-item scale measuring global judgements of life satisfaction. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.
Time frame
Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks2
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. PTSD Checklist-5 scale range 0-63 with 63 indicating highest PTSD severity.
Time frame
Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeksOther outcomes
1
Screening measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item anxiety measure that uses a 4-point scale. Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms.
Time frame
Enrollment/Baseline (0 Weeks)2
Screening measure: Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) assesses 9 symptoms of depression on a 4-point scale. Patient Health Questionnaire-9 range 0-27, with 27 indicating the greatest amount of depression.
Time frame
Enrollment/Baseline (0 Weeks)3
Screening Measure: Blessed Orientation Memory & Concentration Test (BOMC)
The BOMC is a six-item cognitive screening test that evaluates orientation, concentration, and memory. The higher the total weighted score, the more likely the patient has cognitive disability. For this study a score equal to or greater than 16 would mean study exclusion.
Time frame
Enrollment/Baseline (0 Weeks)4
Screening Measure: P4 Screener
The P4 screener asks about the "4 P's": past suicide attempts, suicide plan, probability of completing suicide, and preventive factors. Patients were classified as minimal, lower, and higher risk based upon responses to these 4 items.
Time frame
Enrollment/Baseline (0 Weeks)Sponsors and contacts
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Source ClinicalTrials.gov