Mindfulness Training for PTSD

Recruiting at 4 trial locations

Overseen By Kathleen Gomathi Raman, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Recent suicide attempt, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of classes to help veterans manage symptoms of anxiety, depression, and PTSD. One class, Primary Care Brief Mindfulness Training (PCBMT), teaches mindfulness meditation with a focus on relaxation and acceptance. The other, Moving Forward (MF), teaches problem-solving skills to build resilience. The goal is to determine if these classes can reduce symptoms and improve daily functioning. Veterans enrolled in VA primary care who experience significant stress from anxiety, depression, or PTSD may be well-suited for this trial. As an unphased trial, this study offers veterans a unique opportunity to explore innovative approaches to managing their mental health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you've had a change in psychiatric medication outside of VA primary care in the last 2 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Moving Forward (MF) program is generally easy for participants to handle. Previous studies found that this program, which teaches problem-solving skills, helps veterans manage stress without major side effects. It focuses on building resilience and addressing emotional distress step-by-step.

Regarding the Primary Care Brief Mindfulness Training (PCBMT), studies have found it safe and effective for veterans with PTSD (post-traumatic stress disorder). Participants in past trials reported fewer psychiatric symptoms and improved stress management after attending mindfulness classes. These classes, which include meditation and gentle yoga, emphasize concepts like patience and acceptance.

Both treatments aim to improve mental well-being and have shown effectiveness without significant negative effects. This suggests they are safe options for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they offer new approaches that differ from traditional methods like medication and talk therapy. Moving Forward (MF) aims to empower individuals with practical problem-solving skills, encouraging resilience and emotional regulation through strategies like "stop, slow down, think, and act." Meanwhile, Primary Care Brief Mindfulness Training (PCBMT) adapts Mindfulness-Based Stress Reduction into a more accessible format, incorporating meditation, yoga, and discussions around concepts such as acceptance and letting go. These treatments focus on building self-awareness and coping mechanisms, potentially offering quicker and more holistic ways to manage PTSD symptoms.

What evidence suggests that this trial's treatments could be effective for PTSD?

In this trial, participants will be assigned to one of two treatment arms. Research has shown that the Moving Forward (MF) program, one of the treatments in this trial, helps veterans by teaching problem-solving skills, which can reduce emotional distress. Veterans who completed this program reported feeling less depressed and more resilient, indicating a positive impact on mental health.

Similarly, studies have found that Primary Care Brief Mindfulness Training (PCBMT), the other treatment option in this trial, based on Mindfulness-Based Stress Reduction (MBSR), effectively reduces symptoms of anxiety and depression. Participants in PCBMT reported better stress management and overall health.

Both treatments have shown promise in improving mental health but work differently. MF focuses on building resilience through problem-solving, while PCBMT uses mindfulness techniques to manage stress and emotions. ^{1 2 3 6 7}

Who Is on the Research Team?

Kyle Possemato, PhD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Are You a Good Fit for This Trial?

This trial is for Veterans experiencing anxiety, depression, or PTSD and enrolled in VA primary care. They must have significant distress shown by specific scores on mental health assessments. Those with recent suicide attempts, changes in psychiatric meds, or who prefer specialty mental health care are excluded.

Inclusion Criteria

Participants must 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

Participants must be enrolled in VA primary care through the local VA site

Exclusion Criteria

I changed my psychiatric medication recently, not through VHA primary care.

I have significant memory or thinking problems.

Patients with suicide attempt or desire to commit suicide in the last month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0 weeks

1 visit (in-person)

Treatment

Participants receive either Primary Care Brief Mindfulness Training (PCBMT) or Moving Forward (MF) classes to reduce symptoms of anxiety, depression, and/or PTSD

8 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Assessments at 8, 16, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study compares two treatments: mindfulness meditation (PCBMT) and a problem-solving class (MF). It aims to see if these classes can reduce symptoms of anxiety, depression, PTSD and improve overall functioning among Veterans.

How Is the Trial Designed?

Group I: Primary Care Brief Mindfulness Training (PCBMT) Experimental Treatment 1 Intervention

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.

Group II: Moving Forward (MF) Active Control 1 Intervention

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".

Moving Forward (MF) is already approved in United States for the following indications:

Approved in United States as Moving Forward (MF) for:

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A study involving 62 VA primary care patients with PTSD showed that a brief mindfulness training (BMT) program significantly reduced PTSD and depression symptoms compared to usual care, with benefits maintained at an 8-week follow-up.

The improvements in PTSD severity were linked to specific mindfulness skills, such as describing, nonjudging, and acting with awareness, suggesting these aspects may play a key role in the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial of Primary Care Brief Mindfulness Training for Veterans with PTSD. Possemato, K., Bergen-Cico, D., Treatman, S., et al.[2021]

Mindfulness-based cognitive therapy (MBCT) adapted for combat PTSD showed significant improvement in PTSD symptoms compared to treatment-as-usual, with a notable reduction in avoidance symptoms and PTSD-related negative cognitions.

The study involved 37 participants (20 in the MBCT group and 17 in the TAU group) over an 8-week period, and 75% of MBCT completers demonstrated good compliance and clinically meaningful improvements in their PTSD assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). King, AP., Erickson, TM., Giardino, ND., et al.[2022]

Participation in a 4-week Primary Care brief Mindfulness Program (PCbMP) significantly reduced cortisol levels in veterans with PTSD, indicating a positive effect on hypothalamic pituitary axis (HPA) function.

Veterans who completed at least 4 sessions of the mindfulness program showed a notable decrease in their cortisol awakening response, suggesting that even brief mindfulness interventions can have beneficial physiological effects for those with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reductions in cortisol associated with primary care brief mindfulness program for veterans with PTSD. Bergen-Cico, D., Possemato, K., Pigeon, W.[2021]

Mindfulness training for primary care (MTPC) significantly improved emotion regulation in patients with anxiety, depression, and stress-related disorders, showing reductions in difficulties in emotion regulation scores at both 8 and 24 weeks compared to a low-dose mindfulness comparator.

MTPC also facilitated health behavior change, with 63% of participants successfully initiating their action plans within 3 weeks, compared to only 38% in the low-dose group, indicating its effectiveness in promoting self-management of chronic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. Gawande, R., Smith, L., Comeau, A., et al.[2023]

Primary Care Brief Mindfulness Training (PCBMT) significantly reduced PTSD symptoms and depression in patients compared to a psychoeducational group, with effect sizes indicating moderate to large improvements over a 4-week period.

Participants in the PCBMT group also showed greater enhancements in health responsibility and stress management, suggesting that mindfulness training can promote broader recovery outcomes and may be a preferable initial treatment for those hesitant to engage in traditional PTSD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Brief Primary Care-Based Mindfulness Training Versus a Psychoeducational Group for Veterans With Posttraumatic Stress Disorder. Possemato, K., Bergen-Cico, D., Buckheit, K., et al.[2023]

Mindfulness Based Cognitive Therapy (MBCT) was found to be both acceptable and beneficial for patients with active symptoms of depression and anxiety, with 72% of participants showing improvements in depression scores and 63% in anxiety scores after the 8-week course.

Participants reported significant reductions in their depression (from a mean score of 35.7 to 17.8) and anxiety (from 32.0 to 20.5), indicating that MBCT can effectively reduce symptoms in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory mixed methods study of the acceptability and effectiveness of Mindfulness-Based Cognitive Therapy for patients with active depression and anxiety in primary care. Finucane, A., Mercer, SW.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8796046/

Web-Based Problem-solving Training With and Without ... The objective use of Moving Forward was measured with the number of log-ins. Participants completed pre- and poststudy measures of mental health ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224033957

Problem-solving training for Veterans in home based ... From baseline to post-intervention, Veterans completing five or more PST-HBPC sessions (n = 199) reported significant reductions in depressive symptoms on ...

3. veterantraining.va.gov veterantraining.va.gov/movingforward/

Moving Forward: Overcome Life's Challenges Moving Forward is an online course that teaches skills to help you overcome stressful problems and meet your goals. The course is free and ...

4. researchgate.net researchgate.net/publication/280257404_Moving_forward_A_problem-solving_training_program_to_foster_veteran_resilience

Moving Forward: A Problem-Solving Training Program to ... The program evaluation results indicate that Moving Forward is feasible, well-received by veterans, and yields improvements in social problem ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06162741

Study Details | NCT06162741 | Type I Hybrid Effectiveness ... The study aims include comparing PCBMT to a transdiagnostic problem solving group (Moving Forward, MF) on clinical outcomes, testing mediators and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001198

STEP-Home transdiagnostic group reintegration workshop ... Veterans who participated in SH showed significant pre-post intervention improvement in cognitive and emotional regulation and reintegration status [38].

7. heartbrain.hms.harvard.edu heartbrain.hms.harvard.edu/sites/g/files/omnuum4516/files/2025-03/STEP-Home%20transdiagnostic%20group%20reintegration%20workshop%20to%20improve%20mental%20health%20outcomes%20for%20post-9-11%20veterans.pdf

STEP-Home transdiagnostic group reintegration workshop ... Changes in acquisition of core problem solving and emotional regulation skills were independently associated with improvement in reintegration.