Mindfulness Training for PTSD

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

This trial compares mindfulness meditation and problem-solving skills classes for Veterans with anxiety, depression, or PTSD. It aims to see which method better reduces symptoms and improves overall functioning in 300 Veterans across various locations. Mindfulness-based stress reduction (MBSR) has been studied extensively and shown to improve PTSD symptoms, depression, and overall well-being in veterans.

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.

What data supports the effectiveness of the treatment Moving Forward (MF), Problem-Solving Class, Transdiagnostic Problem Solving Group, Primary Care Brief Mindfulness Training (PCBMT), Mindfulness-Based Stress Reduction (MBSR), Mindfulness Meditation, Primary Care Brief Mindfulness Training (PCBMT) for PTSD?

Research shows that Primary Care Brief Mindfulness Training (PCBMT) can help reduce PTSD symptoms and improve emotional regulation, which is important for managing both mental and physical health issues. Mindfulness-based interventions, like PCBMT, have been found to decrease PTSD severity and are a promising alternative for those hesitant to engage in traditional mental health treatments. ^{1 2 3 4 5}

Is mindfulness training safe for people with PTSD?

Mindfulness training, including programs like Primary Care Brief Mindfulness Training (PCBMT), has been studied in veterans with PTSD and is generally considered safe. These programs focus on improving emotional regulation and have not shown significant safety concerns in the research available. ^{1 2 3 4 5}

How is the treatment 'Mindfulness Training for PTSD' different from other PTSD treatments?

This treatment is unique because it offers a brief mindfulness training specifically in primary care settings, making it more accessible for individuals who are hesitant to engage in traditional mental health care. It focuses on developing emotional regulation skills without exposure to trauma, which can be more acceptable for veterans with PTSD. ^{1 2 4 5 6}

Research Team

Kyle Possemato, PhD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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-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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial of Primary Care Brief Mindfulness Training for Veterans with PTSD. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. [2023]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Reductions in cortisol associated with primary care brief mindfulness program for veterans with PTSD. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). [2022]