Trial Outcomes & Findings for Physiological Augmentation of Mindfulness Meditation (NCT NCT02754557)
NCT ID: NCT02754557
Last Updated: 2022-10-17
Results Overview
The MDI is a 30-item self-report test of dissociative symptomology and it measures six different types of dissociative response. The scales of the MDI are disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, identity dissociation, and total dissociation. Items are scored from 1 to 5 where 1 = never and 5 = very often. Total scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.
COMPLETED
NA
65 participants
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
2022-10-17
Participant Flow
Participants were recruited from Grady Memorial Hospital and the Wesley Woods Center in Atlanta, Georgia, USA. Participant enrollment began in March 2016 and the one month follow-up assessments were completed by September 21, 2021.
Participant milestones
| Measure |
Breath-Focused Meditation
Women with post traumatic stress disorder receiving breath-focused meditation
|
Breath-Focused Meditation Plus Physiological Feedback
Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
38
|
|
Overall Study
Completed Post-treatment Assessment at Week 4
|
27
|
38
|
|
Overall Study
Completed One-month Post-treatment Assessment at Week 8
|
19
|
32
|
|
Overall Study
COMPLETED
|
27
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physiological Augmentation of Mindfulness Meditation
Baseline characteristics by cohort
| Measure |
Breath-Focused Meditation
n=27 Participants
Women with post traumatic stress disorder receiving breath-focused meditation
|
Breath-Focused Meditation Plus Physiological Feedback
n=38 Participants
Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.48 years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
40.11 years
STANDARD_DEVIATION 12.22 • n=7 Participants
|
42.38 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)Population: This analysis includes participants who attended the indicated study visit. One participant in the Breath-Focused Meditation Plus Physiological Feedback group attended the one month post-treatment visit but did not complete the MDI.
The MDI is a 30-item self-report test of dissociative symptomology and it measures six different types of dissociative response. The scales of the MDI are disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, identity dissociation, and total dissociation. Items are scored from 1 to 5 where 1 = never and 5 = very often. Total scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.
Outcome measures
| Measure |
Breath-Focused Meditation
n=27 Participants
Women with post traumatic stress disorder receiving breath-focused meditation
|
Breath-Focused Meditation Plus Physiological Feedback
n=38 Participants
Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback
|
|---|---|---|
|
Multiscale Dissociation Inventory (MDI) Score
Baseline
|
53.19 score on a scale
Standard Deviation 12.99
|
61.58 score on a scale
Standard Deviation 20.00
|
|
Multiscale Dissociation Inventory (MDI) Score
Post-treatment (Week 4)
|
47.15 score on a scale
Standard Deviation 15.13
|
51.00 score on a scale
Standard Deviation 15.53
|
|
Multiscale Dissociation Inventory (MDI) Score
One Month Post-Treatment (Week 8)
|
44.11 score on a scale
Standard Deviation 14.44
|
47.94 score on a scale
Standard Deviation 17.82
|
PRIMARY outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)Population: This analysis includes participants who attended the indicated study visit.
The MPSS is an 18-item instrument assessing the presence and severity of PTSD symptoms related to specific traumatic events in individuals with a known trauma history. Respondents indicate how frequently they experience each item on a scale of 0 to 3 where 0 = not at all and 3 = almost always. PTSD symptomatology over the prior 2 weeks is assessed, yielding a continuous measure of PTSD symptom severity ranging from 0 to 54. A higher score indicates greater symptom severity.
Outcome measures
| Measure |
Breath-Focused Meditation
n=27 Participants
Women with post traumatic stress disorder receiving breath-focused meditation
|
Breath-Focused Meditation Plus Physiological Feedback
n=38 Participants
Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback
|
|---|---|---|
|
Modified PTSD Symptom Scale (MPSS) Score
Baseline
|
27.33 score on a scale
Standard Deviation 7.23
|
28.82 score on a scale
Standard Deviation 8.37
|
|
Modified PTSD Symptom Scale (MPSS) Score
Post-treatment (Week 4)
|
19.63 score on a scale
Standard Deviation 10.54
|
20.97 score on a scale
Standard Deviation 12.27
|
|
Modified PTSD Symptom Scale (MPSS) Score
One Month Post-treatment (Week 8)
|
17.58 score on a scale
Standard Deviation 10.52
|
19.44 score on a scale
Standard Deviation 12.69
|
PRIMARY outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)Population: This analysis includes participants who attended the indicated study visit. One participant in the Breath-Focused Meditation Plus Physiological Feedback group attended the one month post-treatment visit but did not complete the Kentucky Mindfulness Scale.
The Kentucky Mindfulness Scale is a 39-item scale that assesses skills related to what one does while practicing mindfulness. Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. Total scores range from 39 to 195 and higher scores reflect more mindfulness.
Outcome measures
| Measure |
Breath-Focused Meditation
n=27 Participants
Women with post traumatic stress disorder receiving breath-focused meditation
|
Breath-Focused Meditation Plus Physiological Feedback
n=38 Participants
Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback
|
|---|---|---|
|
Kentucky Mindfulness Scale Score
Baseline
|
122.19 score on a scale
Standard Deviation 17.68
|
117.55 score on a scale
Standard Deviation 19.24
|
|
Kentucky Mindfulness Scale Score
Post-treatment (Week 4)
|
125.37 score on a scale
Standard Deviation 20.25
|
125.79 score on a scale
Standard Deviation 17.29
|
|
Kentucky Mindfulness Scale Score
One Month Post-treatment (Week 8)
|
124.58 score on a scale
Standard Deviation 22.25
|
126.65 score on a scale
Standard Deviation 16.78
|
PRIMARY outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)Population: This analysis includes participants who attended the indicated study visit. One participant in the Breath-Focused Meditation Plus Physiological Feedback group attended the one month post-treatment visit but did not complete the Multidimensional Assessment of Interoceptive Awareness assessment.
This is a clinical measure that assesses various aspects of interoception, including ability to attend to body sensations, regulate distress by attending to body sensations, and experiencing body sensations as safe and trustworthy. The instrument includes 32 items and which are scored from 0 to 5, where 0 = never and 5 = always. Total scores range from 0 to 160 and higher scores indicate greater awareness of body sensations.
Outcome measures
| Measure |
Breath-Focused Meditation
n=27 Participants
Women with post traumatic stress disorder receiving breath-focused meditation
|
Breath-Focused Meditation Plus Physiological Feedback
n=38 Participants
Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback
|
|---|---|---|
|
Multidimensional Assessment of Interoceptive Awareness Score
Baseline
|
98.22 score on a scale
Standard Deviation 24.39
|
86.45 score on a scale
Standard Deviation 25.03
|
|
Multidimensional Assessment of Interoceptive Awareness Score
Post-treatment (Week 4)
|
107.37 score on a scale
Standard Deviation 31.46
|
106.92 score on a scale
Standard Deviation 24.94
|
|
Multidimensional Assessment of Interoceptive Awareness Score
One Month Post-treatment (Week 8)
|
110.63 score on a scale
Standard Deviation 28.29
|
105.29 score on a scale
Standard Deviation 27.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe CAPS is a 30-item structured interview that can be used to make current and lifetime diagnosis of post traumatic stress disorder (PTSD) as well as assess PTSD symptoms over the past week. Questions also examine the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The identification of an index traumatic event to serves as the basis for symptom inquiry. The full interview takes approximately 45-60 minutes to administer. Items are scored from 0 to 4 where 0 = the symptom is absent and 4 = the symptom is incapacitating. A symptom severity score is obtained by summing items 1-20. Total scores range from 0 to 80 and a higher score indicates more severe PTSD symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMini International Neuropsychiatric Interview is a semistructured interview that will be used to assess for concurrent mood, substance, and psychotic disorders. The interview takes 30 minutes - 1 hour to administer. Participants answer "yes" or "no" to questions about symptoms they have been having; from these responses a clinician can diagnose lifetime and/or current presence of 22 psychiatric conditions. The number of instrument items used per interview depends on responses to previous questions and the interview is not designed to provide a numeric total score.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThis is a clinical measure designed to quickly assess the nature and extent of recreational use of cannabis during the last 24 hours. The instrument includes a 15-item scale where respondents indicate how much the agree with reasons for using marijuana, where 0 = strongly disagree and 5 = strongly agree. The full measure will be administered at the beginning of study participation, and one question about drug use in the past day (if applicable) will be administered on study intervention days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 4During the Affective Number Stroop (ANS) Task, participants are instructed to rapidly identify the number of numbers in a given display while ignoring evocative distractor images (trauma-relevant scenes) while in a MRI scanner. In these trials, the number of numbers presented is either consistent or inconsistent with the actual number displayed, such that there are both congruent and incongruent trials. The participants will be presented with positive and neutral pictures in addition to the negative trauma-relevant images. The task will be completed in the MRI scanner during both the pre- and post-treatment sessions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 4This is a computerized neuropsychological assessment that is designed to examine different domains of cognitive functioning. The executive functioning and memory components of this battery will be administered, which take approximately 30 minutes to complete.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 4 (post-treatment), Week 8 (one month post-treatment)The PABQ includes 25 items asking participants how often they engaged in certain behaviors in the past 3 weeks. Responses are given on a 4-point scale where 1 = almost never and 4 = almost always. Total scores range from 25 to 100 and higher scores indicate greater avoidance. This questionnaire will be given at post-treatment and follow-up time points to capture participants' avoidance behaviors during this time.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)The CSES is a 26-item scale that measures one's perceived ability to cope with life's difficulties. Responses are given on a scale from 0 to 10 where 0 = cannot do at all and 10 = certain can do. Total scores range from 0 to 260 where higher scores indicate greater self-efficacy with coping skills.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)This is a 7 Item measure using a 7-point likert scale that will examine changes over time in self-efficacy on a state level. Responses to items range from 1 = strongly disagree to 7 = strongly agree. Total scores range from 1 to 49 where higher scores indicate greater self-efficacy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe Moral Injury Events Scale for Civilians (MIES-C) measurement is a 10-item scale assessing for the presence of potentially morally injurious events and feelings of distress that can emerge in the aftermath of these events. Responses are given on a 6-point scale where 1 = strongly agree and 6 = strongly disagree. Total scores range from 10 to 60 and lower scores indicate more exposure to events that conflict with the respondents sense of right and wrong.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)This is a 20-item self-report measure that assesses attentional control a 4-point Likert scale, where 1 = almost never and 4 = always. Total scores range from 20 to 80 and higher scores indicate greater difficulty with attentional control.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 4 (post-treatment)The STAI is a 40-item self-report measure that uses a 4-point Likert scale to evaluate both state and trait anxiety. Total scores range from 40 to 160 and items are scored so that a higher total score indicates greater symptoms of anxiety. This is administered at the pre-MRI and post-MRI data collection points for every MRI visit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 (post-treatment)This is a 6-item self-report measure that indicates how intense one is feeling certain emotions using a 10-point Likert scale. Total scores range from 0 to 60 with higher scores indicating greater intensity of emotions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)The MAP-SR is an 18-item self-report measure that assesses the motivation and pleasure domain of negative symptoms. Items are rated on a 5-point Likert scale and total scores range from 0 to 72. Certain items are reverse scored so that lower scores indicate greater pathology.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention and post-intervention of each session up to Week 4This is a 21-item self-report measure that uses a 5-point Likert scale to assess one's perceived level of awareness and attention to the present moment and environment within a given frame of time (i.e. the last 10 minutes). This is administered before and after each intervention session. Responses are given on a scale from 1 (not at all) to 5 (very well). Total scores range from 21 to 105 and higher scores indicate greater mindfulness.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 4 (post-treatment)The CSQ is an 11-item self-report measure to assess how the intervention satisfied the participant's expectations and/or if it helped their daily lives in any way. The questionnaire contains a mix of scaled responses and open ended questions and there is not a summary score for this measurement.
Outcome measures
Outcome data not reported
Adverse Events
Breath-Focused Meditation
Breath-Focused Meditation Plus Physiological Feedback
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place