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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162741
• Other study ID #: IIR 22-013
• Secondary ID: 1 I01 HX003626-0
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Kyle Possemato, PhD
• Phone: (315) 425-4400
• Email: kyle.possemato[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Primary Care Brief Mindfulness Training (PCBMT)
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.
• Moving Forward (MF)
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.

Locations

Country	Name	City	State
United States	Phoenix VA Health Care System, Phoenix, AZ	Phoenix	Arizona
United States	St. Louis VA Medical Center John Cochran Division, St. Louis, MO	Saint Louis	Missouri
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Enrollment/Baseline (0 Weeks)
Other	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.	Enrollment/Baseline (0 Weeks)
Other	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.	Enrollment/Baseline (0 Weeks)
Other	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.	Enrollment/Baseline (0 Weeks)
Other	Five Facet Mindfulness Questionnaire (FFMQ-15)	The Five Facet Mindfulness Questionnaire (FFMQ) is a 15-item scale that measures observing, describing, acting with awareness, non-judging, and non-reactivity. The total subscale will be used as the primary measure of mindfulness. For all FFMQ-15 subscales, scores range from 3-15. Higher scores are indicative of someone who is more mindful in their everyday life.	Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Other	Emotion Regulation Questionnaire (ERQ)	The ERQ is a 10-item self-report measure designed to assess the use cognitive reappraisal and expressive suppression. The Emotion Regulation Questionnaire (ERQ) has a range of 7-70. The higher the score, the greater the use of that particular emotion regulation strategy or strategies.	Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Other	Acceptance and Action Questionnaire (AAQ-II)	The AAQ-II measures psychological flexibility (the inverse of experiential avoidance) with 7-items. Score range: 7-49. Higher scores equal greater levels of psychological inflexibility.	Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Other	White Bear Suppression Inventory (WBSI)	The White Bear Suppression Inventory (WBSI) is a 15-item questionnaire designed to measure thought suppression. The total score is derived from summing the responses, and scores range from 15 to 75. Higher scores indicate higher levels of thought suppression.	Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Other	The Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE)	The PRAPARE will measure social determinants of health and unmet social needs. This reliable and valid measure consists of 17-items assessing race, education, ethnicity, employment, insurance, income, language, material security, housing status/ stability, transportation, social integration and support, neighborhood, stress, safety, domestic violence and incarceration history.	Enrollment/Baseline (0 weeks)
Other	Demographics and Military Background Questionnaire	The Demographics and Military Background Questionnaire was adapted from the George W. Bush Institute's Warrior Wellness Alliance (WWA) questionnaire "Common Questions to Better Serve Our Vets" to collect pertinent demographics and military information.	Enrollment/Baseline (0 weeks)
Primary	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	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.	Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Secondary	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.	Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks