Loving-Kindness Meditation for PTSD

NCT01962714 | Completed Results DMC

• 2 other identifiers: MHBA-006-13S5I01CX000857-02
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will assess whether a novel complementary and alternative medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version; CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans with current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that Veterans randomized to LKM will report mean reductions in PTSD and depressive symptom severity that are not meaningfully worse than CPT-C. The investigators further hypothesize that reductions in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom improvement for those assigned to CPT-C than those assigned to LKM.

Conditions

Posttraumatic Stress Disorder; Depression

Keywords

Behavior therapies, cognitive; Mindfulness; Emotion; Group therapy

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS-5) Score

  PTSD diagnostic severity was measured using the 30-item CAPS-5 structured interview (range 0-80; higher scores indicate worse PTSD). Linear mixed effects models (LMM) were used to analyze continuous outcomes, with time and time by treatment interaction included as fixed effects to determine if differences exist between conditions by time. Non-inferiority of LKM to CPT-C was claimed if the lower limit of the 95% confidence interval for difference in change rate from baseline to 6-month follow-up in mean CAPS or depression score was greater than (i.e., did not extend beyond) negative delta (defined as 5 points on the CAPS-5 measure). A 2-sided 95% confidence interval of the difference in change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM) was calculated, with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.

  6 months post-intervention

• NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score

  Depression was assessed using the National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) depression measure. This scale utilizes item-response theory and is scored using a T-score metric with a mean of 50 and SD=10 in the US general population. Higher scores indicate more severe depression.

  6 months post-intervention

Study Arms (2)

Loving-Kindness Meditation

EXPERIMENTAL

A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.

Behavioral: Loving-Kindness Meditation

Cognitive Processing Therapy - Cognitive Only

ACTIVE COMPARATOR

A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.

Behavioral: Cognitive Processing Therapy

Interventions

Loving-Kindness Meditation BEHAVIORAL

12-week loving-kindness meditation course

Loving-Kindness Meditation

Cognitive Processing Therapy BEHAVIORAL

12-week CPT course

Cognitive Processing Therapy - Cognitive Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 diagnosis of PTSD,
• or over,
• English fluency,
• Willingness to not participate in Mindfulness-Based Stress Reduction or other meditation programs, as well as Prolonged Exposure (PE) or CPT during the study period.

You may not qualify if:

• Any of the following substance use criteria: 1) Use in the past 90 days of illicit substance (do not include cannabis)/ street drug (non-prescribed); 2) Use in the past 90 days of prescription drug of abuse, use is not as prescribed AND poses safety concern
• Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by current drinking AND dt's or seizure in past year
• Suicidal or homicidal ideation with intent or plan
• Attempted harm to Self or others in the past month
• A lifetime psychotic disorder or current psychotic symptoms
• Chart diagnoses of borderline personality disorder or antisocial personality disorder
• In-patient admission for psychiatric reasons within the past month
• Prior participation in LKM or CPT
• Dementia

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (2)

• Kearney DJ, Malte CA, McManus C, Martinez ME, Felleman B, Simpson TL. Loving-kindness meditation for posttraumatic stress disorder: a pilot study. J Trauma Stress. 2013 Aug;26(4):426-34. doi: 10.1002/jts.21832. Epub 2013 Jul 25.

  PMID: 23893519 RESULT

• Kearney DJ, Malte CA, Storms M, Simpson TL. Loving-Kindness Meditation vs Cognitive Processing Therapy for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216604. doi: 10.1001/jamanetworkopen.2021.6604.

  PMID: 33861329 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

The study involved predominantly male veterans from one facility; the results may not generalize to nonveterans or veterans in other regions. Treatment credibility and adequacy of blinding of the clinician-assessor of PTSD symptoms were not assessed.

Results Point of Contact

• Title: David Kearney, MD
• Organization: VA Puget Sound Health Care System

david.kearney@va.gov

206-277-1445

Study Officials

• David J. Kearney, MD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: December 1, 2014
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: March 17, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)