Trial Outcomes & Findings for Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma (NCT NCT02640690)

Last Updated: 2024-10-08

Results Overview

Clinician-Administered PTSD Scale for DSM-5 also known as CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a structured interview that was used to assess current (past month) PTSD symptom severity. The CAPS-5 total symptom severity score is the sum of 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

131 participants

Primary outcome timeframe

Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

Results posted on

2024-10-08

Participant Flow

Recruitment 2016-2020 at two large Veterans Affairs (VA) Medical Centers in the US

200 women consented. Additional assessments were conducted to confirm study eligibility. Women were considered protocol enrolled after study eligibility was confirmed. Of the 200, 35 did not meet inclusion criteria, 17 declined to participate prior to randomization, and 16 were lost to follow up, resulting in 132 women who were protocol enrolled and randomized; of those, one participant was administratively withdrawn (was enrolled in error). Thus, the final protocol enrollment was n=131.

Participant milestones

Participant milestones
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
Overall Study STARTED	72	59
Overall Study COMPLETED	47	27
Overall Study NOT COMPLETED	25	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
Overall Study Lost to Follow-up	7	7
Overall Study Withdrawal by Subject	16	20
Overall Study Partial completion (insufficient sessions)	2	5

Baseline Characteristics

The CAPS-5 for two participants were incompletely scored by interviewer, therefore data are not usable.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) n=72 Participants 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) n=59 Participants 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=72 Participants	0 Participants n=59 Participants	0 Participants n=131 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=72 Participants	57 Participants n=59 Participants	124 Participants n=131 Participants
Age, Categorical >=65 years	5 Participants n=72 Participants	2 Participants n=59 Participants	7 Participants n=131 Participants
Age, Continuous	48.19 years n=72 Participants	48.27 years n=59 Participants	48.23 years n=131 Participants
Sex: Female, Male Female	72 Participants n=72 Participants	59 Participants n=59 Participants	131 Participants n=131 Participants
Sex: Female, Male Male	0 Participants n=72 Participants	0 Participants n=59 Participants	0 Participants n=131 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=72 Participants	4 Participants n=59 Participants	4 Participants n=131 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=72 Participants	55 Participants n=59 Participants	127 Participants n=131 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=72 Participants	0 Participants n=59 Participants	0 Participants n=131 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=72 Participants	1 Participants n=59 Participants	1 Participants n=131 Participants
Race (NIH/OMB) Asian	1 Participants n=72 Participants	0 Participants n=59 Participants	1 Participants n=131 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=72 Participants	0 Participants n=59 Participants	0 Participants n=131 Participants
Race (NIH/OMB) Black or African American	51 Participants n=72 Participants	44 Participants n=59 Participants	95 Participants n=131 Participants
Race (NIH/OMB) White	14 Participants n=72 Participants	11 Participants n=59 Participants	25 Participants n=131 Participants
Race (NIH/OMB) More than one race	5 Participants n=72 Participants	3 Participants n=59 Participants	8 Participants n=131 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=72 Participants	0 Participants n=59 Participants	1 Participants n=131 Participants
Region of Enrollment United States	72 Participants n=72 Participants	59 Participants n=59 Participants	131 Participants n=131 Participants
Clinician Assessed PTSD Scale-5 (CAPS-5)	36.73 score on a scale STANDARD_DEVIATION 8.79 • n=71 Participants • The CAPS-5 for two participants were incompletely scored by interviewer, therefore data are not usable.	35.52 score on a scale STANDARD_DEVIATION 7.49 • n=58 Participants • The CAPS-5 for two participants were incompletely scored by interviewer, therefore data are not usable.	36.19 score on a scale STANDARD_DEVIATION 8.22 • n=129 Participants • The CAPS-5 for two participants were incompletely scored by interviewer, therefore data are not usable.
PTSD Symptom Checklist (PCL-5)	49.62 score on a scale STANDARD_DEVIATION 12.19 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	48.69 score on a scale STANDARD_DEVIATION 13.62 • n=59 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	49.20 score on a scale STANDARD_DEVIATION 12.82 • n=130 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.
Beck Depression Inventory-II (BDI-II)	28.04 score on a scale STANDARD_DEVIATION 9.83 • n=69 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Some participants missed individual items in this measure, making their data unusable.	28.98 score on a scale STANDARD_DEVIATION 11.79 • n=57 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Some participants missed individual items in this measure, making their data unusable.	28.47 score on a scale STANDARD_DEVIATION 10.72 • n=126 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Some participants missed individual items in this measure, making their data unusable.
Pittsburgh Sleep Quality Index (PSQI)	14.07 score on a scale STANDARD_DEVIATION 3.25 • n=69 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Four participants missed individual items in this measure, making their data unusable.	14.53 score on a scale STANDARD_DEVIATION 3.08 • n=57 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Four participants missed individual items in this measure, making their data unusable.	14.28 score on a scale STANDARD_DEVIATION 3.17 • n=126 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Four participants missed individual items in this measure, making their data unusable.
Difficulties in Emotion Regulation Scale (DERS)	92.10 score on a scale STANDARD_DEVIATION 25.98 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Three participants missed individual items in this measure, making their data unusable.	96.46 score on a scale STANDARD_DEVIATION 23.58 • n=56 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Three participants missed individual items in this measure, making their data unusable.	94.03 score on a scale STANDARD_DEVIATION 24.95 • n=127 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Three participants missed individual items in this measure, making their data unusable.
BPI Pain Severity	5.06 score on a scale STANDARD_DEVIATION 2.00 • n=63 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.	5.28 score on a scale STANDARD_DEVIATION 2.17 • n=53 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.	5.16 score on a scale STANDARD_DEVIATION 2.07 • n=116 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.
BPI Pain Interference	4.90 score on a scale STANDARD_DEVIATION 2.68 • n=63 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.	5.47 score on a scale STANDARD_DEVIATION 2.49 • n=53 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.	5.16 score on a scale STANDARD_DEVIATION 2.60 • n=116 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.
DSM-5 Level 2-Somatic Symptom- adaptation of PHQ-15 (Patient Health Questionnaire Physical Symptoms)	13.22 score on a scale STANDARD_DEVIATION 4.78 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	14.69 score on a scale STANDARD_DEVIATION 4.39 • n=59 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	13.89 score on a scale STANDARD_DEVIATION 4.65 • n=130 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.
PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a T-score	40.63 T-score STANDARD_DEVIATION 7.25 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	41.00 T-score STANDARD_DEVIATION 6.41 • n=59 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	40.80 T-score STANDARD_DEVIATION 6.86 • n=130 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.
PROMIS v2.0 - Emotional Support -Short Form 4a T-Score	46.78 T-score STANDARD_DEVIATION 9.44 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	45.37 T-score STANDARD_DEVIATION 10.70 • n=59 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	46.14 T-score STANDARD_DEVIATION 10.02 • n=130 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.
PROMIS V2.0 Satisfaction with Social Roles and Activities - Short Form 4a T-score	39.92 T-score STANDARD_DEVIATION 6.55 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	40.38 T-score STANDARD_DEVIATION 7.72 • n=59 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	40.13 T-score STANDARD_DEVIATION 7.09 • n=130 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.
PROMIS v2.0 - Social Isolation - Short Form 4a T-score	60.29 T-score STANDARD_DEVIATION 8.14 • n=71 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	59.17 T-score STANDARD_DEVIATION 8.18 • n=59 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.	59.78 T-score STANDARD_DEVIATION 8.14 • n=130 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study.
Health-related Quality of Life: Veterans Rand 12 (VR12) Mental Health	32.58 score on a scale STANDARD_DEVIATION 11.32 • n=70 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Two participants missed individual items in this measure, making their data unusable.	30.69 score on a scale STANDARD_DEVIATION 10.34 • n=58 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Two participants missed individual items in this measure, making their data unusable.	31.72 score on a scale STANDARD_DEVIATION 10.88 • n=128 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Two participants missed individual items in this measure, making their data unusable.
Health-related Quality of Life: Veterans Rand 12 (VR12) Physical Health	38.24 score on a scale STANDARD_DEVIATION 11.82 • n=70 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.	37.66 score on a scale STANDARD_DEVIATION 11.87 • n=58 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.	37.98 score on a scale STANDARD_DEVIATION 11.80 • n=128 Participants • One TCTSY participant did not complete self-report measures at baseline, then withdrew from study. Several participants missed individual items in this measure, making their data unusable.
C-Reactive Protein (CRP)	0.73 LN(mg/L) STANDARD_DEVIATION 1.38 • n=55 Participants • Some participants did not have blood samples drawn, resulting in missing data.	0.99 LN(mg/L) STANDARD_DEVIATION 1.28 • n=38 Participants • Some participants did not have blood samples drawn, resulting in missing data.	0.83 LN(mg/L) STANDARD_DEVIATION 1.34 • n=93 Participants • Some participants did not have blood samples drawn, resulting in missing data.
Interleukin-6 (IL-6) Pro-inflammatory Cytokine	1.05 LN(pg/mL) STANDARD_DEVIATION 1.64 • n=55 Participants • Some participants did not have blood drawn, resulting in missing data.	1.01 LN(pg/mL) STANDARD_DEVIATION 1.56 • n=38 Participants • Some participants did not have blood drawn, resulting in missing data.	1.03 LN(pg/mL) STANDARD_DEVIATION 1.60 • n=93 Participants • Some participants did not have blood drawn, resulting in missing data.
Interleukin-10 (IL-10) Anti-inflammatory Cytokine	2.59 LN(pg/mL) STANDARD_DEVIATION 1.60 • n=55 Participants • Some participants did not have blood drawn, resulting in missing data.	2.76 LN(pg/mL) STANDARD_DEVIATION 1.76 • n=38 Participants • Some participants did not have blood drawn, resulting in missing data.	2.66 LN(pg/mL) STANDARD_DEVIATION 1.66 • n=93 Participants • Some participants did not have blood drawn, resulting in missing data.

PRIMARY outcome

Timeframe: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

Population: ITT sample with both baseline and 3-months post-intervention data. Some participants were lost to attrition.

Outcome measures

Outcome measures
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) n=39 Participants 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) n=27 Participants 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention	-11.41 score on a scale Standard Deviation 12.32	-14.48 score on a scale Standard Deviation 12.01

PRIMARY outcome

Population: ITT sample with both baseline and 3-months post-intervention data. Some participants were lost to attrition.

The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity (worse outcomes). Within group changes in mean total PCL-5 score from baseline to 3-month post-intervention are reported here.

Outcome measures

Outcome measures
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) n=39 Participants 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) n=27 Participants 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention	-9.99 score on a scale Standard Deviation 18.6	-13.22 score on a scale Standard Deviation 17.39

SECONDARY outcome

Population: ITT sample with both baseline and 3-months post-intervention data. Some participants were lost to attrition.

The VR-12 is a12-item self-rating scale that assess health-related quality of life in veterans and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Mental Component Summary and the Physical Component Summary. The Mental Component Score (MCS) measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health). The VR-12 is veteran population-normed with each component to have a mean score of 50 and a standard deviation of 10. Scores greater than 50 represent above average health status (better outcomes). The change in the mean MCS from baseline to 3-months post-treatment are presented here.

Outcome measures

Outcome measures
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) n=40 Participants 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) n=28 Participants 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention	4.92 score on a scale Standard Deviation 13.26	7.14 score on a scale Standard Deviation 9.15

SECONDARY outcome

Population: ITT sample with both baseline and 3-months post-intervention data. Some participants were lost to attrition.

The VR-12 is a 12-item self-rating scale that assess health-related quality of life in veterans and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary and the Mental Component Summary. The Physical Component Score (PCS) measures physical aspects of quality of life and ranges from 0 (extremely poor physical health) to 100 (extremely good physical health), thus has a possible range of 0-100. The VR-12 is veteran population-normed with each component to have a mean score of 50 and a standard deviation of 10. Scores greater than 50 represent above average health status (better outcomes).

Outcome measures

Outcome measures
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) n=40 Participants 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) n=27 Participants 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention	-2.74 score on a scale Standard Deviation 8.34	-2.04 score on a scale Standard Deviation 9.68

SECONDARY outcome

Population: ITT sample with both baseline and 3-months post-intervention data. Some participants were lost to attrition.

The Brief Pain Inventory (BPI) contains three questions regarding pain severity. Pain severity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain; with each rated on an ordinal scale from "0" = "no pain" to "10" = "pain as bad as you can imagine." The pain severity score is the mean of the three pain severity item scores, with a potential range of 0-10; higher scores indicate worse outcomes.

Outcome measures

Outcome measures
Measure	Trauma Center Trauma-Sensitive Yoga (TCTSY) n=34 Participants 10-weekly 1-hour TCTSY Sessions Trauma Center Trauma Sensitive Yoga Intervention (TCTSY): (10) 1-hour sessions of trauma sensitive yoga	Cognitive Processing Therapy (CPT) n=23 Participants 12-weekly 1.5 hour CPT Sessions Cognitive Processing Therapy: (12) 1.5 hour sessions of cognitive processing therapy
BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention	0.17 score on a scale Standard Deviation 1.66	0.30 score on a scale Standard Deviation 1.42

SECONDARY outcome

Population: ITT sample with both baseline and 3-months post-intervention data. Some participants were lost to attrition.

The Brief Pain Inventory (BPI) contains seven questions regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The pain interference score is the mean of the seven pain interference item scores, with a potential range of 0-10; higher scores indicate worse outcomes.