Posttraumatic Stress Disorder, Depression
Conditions
Keywords
Behavior therapies, cognitive, Mindfulness, Emotion, Group therapy
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.
Detailed 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.
Interventions
BEHAVIORALLoving-Kindness Meditation
12-week loving-kindness meditation course
BEHAVIORALCognitive Processing Therapy
12-week CPT course
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS-5) Score | 6 months post-intervention | 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. |
| NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score | 6 months post-intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 91 |
| 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. | 93 |
| Total | 184 |
Baseline characteristics
| Characteristic | Total | Loving-Kindness Meditation | Cognitive Processing Therapy - Cognitive Only |
|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 13.1 | 58.2 years STANDARD_DEVIATION 12.5 | 56.1 years STANDARD_DEVIATION 13.7 |
| Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5) | 35.53 units on a scale STANDARD_DEVIATION 11.77 | 35.54 units on a scale STANDARD_DEVIATION 12.12 | 35.53 units on a scale STANDARD_DEVIATION 11.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 175 Participants | 88 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 24 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 23 Participants | 11 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 107 Participants | 53 Participants | 54 Participants |
| Region of Enrollment United States | 184 Participants | 91 Participants | 93 Participants |
| Sex/Gender, Customized Gender Female | 30 Participants | 13 Participants | 17 Participants |
| Sex/Gender, Customized Gender Male | 153 Participants | 77 Participants | 76 Participants |
| Sex/Gender, Customized Gender Transgender | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 91 | 0 / 93 |
| other Total, other adverse events | 11 / 91 | 18 / 93 |
| serious Total, serious adverse events | 5 / 91 | 3 / 93 |
Outcome results
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.
Time frame: 6 months post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Loving-Kindness Meditation | Clinician Administered PTSD Scale (CAPS-5) Score | 25.92 units on a scale |
| Cognitive Processing Therapy - Cognitive Only | Clinician Administered PTSD Scale (CAPS-5) Score | 28.02 units on a scale |
Comparison: The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.95% CI: [-2.59, 6.78]
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.
Time frame: 6 months post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Loving-Kindness Meditation | NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score | 58.88 units on a scale |
| Cognitive Processing Therapy - Cognitive Only | NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score | 61.22 units on a scale |
Comparison: The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.95% CI: [-0.52, 5.2]