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| ID | Type | Description | Link |
|---|---|---|---|
| 5I01CX000857-02 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loving-Kindness Meditation | Experimental | A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loving-Kindness Meditation | Behavioral | 12-week loving-kindness meditation course |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Kearney, MD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23893519 | Result | 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. | |
| 33861329 | Derived | 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. |
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A de-identified, anonymized dataset will be created and shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loving-Kindness Meditation | A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants. Loving-Kindness Meditation: 12-week loving-kindness meditation course |
| FG001 | Cognitive Processing Therapy - Cognitive Only | A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants. Cognitive Processing Therapy: 12-week CPT course |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Loving-Kindness Meditation | The intervention consisted of 12 weekly 90-minute group sessions. In Loving-Kindness Meditation, a person sits and calls to mind a particular person (e.g., a good friend) and silently repeats phrases that invoke goodwill for that person, e.g., the desire for safety, happiness, health, and peace. Over 12 weeks, the practice expands to bring to mind other individuals or categories of people, including themselves, neutral persons, and those who have caused difficulty or harm, changing the phrases as needed. Participants are asked to notice any thoughts and feelings elicited by the phrases with an attitude of kindness, curiosity, and non-judgment, regardless of content. Each session begins with either mindfulness meditation (weeks 1 & 2) or LKM meditation (weeks 3 through 12) followed by group discussion and additional LKM teaching and practice. Homework for LKM consisted of 30 minutes of meditation 6 days per week using compact disks (CDs) as well as informal LKM practice in daily life. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months post-intervention |
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From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loving-Kindness Meditation | A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in depression score | Psychiatric disorders | Systematic Assessment | An increase in depression severity of 2 or more severity categories was categorized as an adverse event (AE). A rubric was utilized that transformed PROMIS depression scores to PHQ-9 scores for this purpose. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kearney, MD | VA Puget Sound Health Care System | 206-277-1445 | david.kearney@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2014 | Nov 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Cognitive Processing Therapy | Behavioral | 12-week CPT course |
|
| BG001 | Cognitive Processing Therapy - Cognitive Only | CPT-C does not include writing a trauma narrative. The intervention is based on Resick and colleagues' manual for treating PTSD among military veterans, which combines cognitive restructuring with emotional processing of trauma- related content. Sessions initially focus on rigid or inaccurate beliefs about the traumatic event itself, which often reflect self-blame or hindsight bias. Later sessions address over-generalized beliefs about self and others that result from a traumatic event relevant to five key areas: safety, trust, power, esteem, and intimacy. Clients learn to identify and modify their beliefs to develop more balanced, flexible, and ultimately, more adaptive beliefs. Homework for CPT-C consisted of 30 minutes of homework 6 days a week, including writing an impact statement at the beginning and the end of treatment and completing worksheets and exercises regarding safety, trust, power/control, esteem, and intimacy. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5) | The CAPS-5 structured interview was performed by a clinician blinded to randomization arm. Range 0-80; higher scores indicate worse PTSD. | Mean | Standard Deviation | units on a scale |
|
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants. Loving-Kindness Meditation: 12-week loving-kindness meditation course |
| OG001 | Cognitive Processing Therapy - Cognitive Only | A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants. Cognitive Processing Therapy: 12-week CPT course |
|
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| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months post-intervention |
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| 2 |
| 91 |
| 5 |
| 91 |
| 11 |
| 91 |
| EG001 | Cognitive Processing Therapy - Cognitive Only | A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants. | 0 | 93 | 3 | 93 | 18 | 93 |
| Inpatient psychiatric admission | Psychiatric disorders | Systematic Assessment |
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| Risk of Harm to Others | Psychiatric disorders | Systematic Assessment |
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| Suicidality with Intent or Plan requiring staff intervention | Psychiatric disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Increase in PTSD severity score | Psychiatric disorders | Systematic Assessment | An increase of 20 or more points on the CAPS-5 score since the last assessment was categorized as an AE. |
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| Risk of harm to others | Psychiatric disorders | Systematic Assessment |
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| D001519 | Behavior |
For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen's d effect size of approximately 0.50. |