Loving-Kindness Meditation for PTSD

Depression Clinical Trial

Official title:

A Trial of Loving-Kindness Meditation and Cognitive Processing Therapy for PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962714
• Other study ID #: MHBA-006-13S
• Secondary ID: 5I01CX000857-02
• Status: Completed
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: November 29, 2018

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aim 1: Evaluate if LKM is non-inferior to CPT-C in producing reductions in PTSD symptoms among Veterans with current PTSD. Aim 2: Evaluate the non-inferiority of LKM and CPT-C in producing reductions in depressive symptoms among Veterans with current PTSD. Exploratory Aim: Evaluate potential mediators of response to LKM and to CPT to provide preliminary information regarding whether they are consistent with the mechanisms of change conceptualized by each intervention to be associated with improvement in PTSD and depression.

Methods: A randomized controlled non-inferiority trial comparing LKM to CPT-C. In the proposed project 170 Veterans with PTSD will be randomized to LKM or CPT-C. Comprehensive assessments will be performed at baseline as well as at the end of the 12-week interventions and 3 and 6 months later. PTSD symptoms, depression, posttraumatic maladaptive cognitions and self-compassion will be assessed weekly during the treatment phase to assess temporality of change and to assess mediators of outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 diagnosis of PTSD,

• 18 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.

Exclusion Criteria:

• 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

• Uncontrolled bipolar disorder (ie current mania, current hypomania is not an exclusion)

• 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

Related Conditions & MeSH terms

• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Loving-Kindness Meditation
12-week loving-kindness meditation course
• Cognitive Processing Therapy
12-week CPT course

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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