Trial Outcomes & Findings for Primary-Care Based Mindfulness Intervention (NCT NCT03922581)
NCT ID: NCT03922581
Last Updated: 2024-09-19
Results Overview
Retention rates were assessed using session attendance. Previous mindfulness-based stress reduction (MBSR) interventions among low-income minority populations have yielded completion rates of 53-80%. Based on 80% completion rates of MBSR in primary care and 75% completion rates of MBCT both in combat vet samples and the anticipated improved accessibility through primary care, it is expected that subjects in the intervention group will evidence at least 75% retention and follow-up rates.
COMPLETED
NA
80 participants
Baseline through Follow-up (1 month after the end of the 8-week intervention)
2024-09-19
Participant Flow
Participants were recruited from Grady Health System in Atlanta, Georgia, USA. Participant enrollment began September 14, 2018 and the final study assessment occurred on August 18, 2023.
Study enrollment was suspended in March 2020 due to the Coronavirus 2019 (COVID-19) pandemic. Enrollment reopened in September 2020 with a virtual intervention, rather than an in-person intervention.
Participant milestones
| Measure |
Mindfulness-Based Cognitive Therapy
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
Mindfulness-Based Cognitive Therapy: The intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants return one month after the intervention has ended for a follow-up assessment.
|
Wait-list Control Group
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
36
|
|
Overall Study
Started In-Person Intervention
|
18
|
16
|
|
Overall Study
In-Person Intervention Participants Completing the Post-Intervention Assessment
|
11
|
15
|
|
Overall Study
In-Person Intervention Participants Completing the Follow-up Assessment 1 Month After Intervention
|
10
|
14
|
|
Overall Study
Started Virtual Intervention
|
26
|
20
|
|
Overall Study
Virtual Intervention Participants Completing the Post-Intervention Assessment
|
14
|
18
|
|
Overall Study
Virtual Intervention Participants Completing the Follow-up Assessment 1 Month After Intervention
|
12
|
12
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
22
|
10
|
Reasons for withdrawal
| Measure |
Mindfulness-Based Cognitive Therapy
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
Mindfulness-Based Cognitive Therapy: The intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants return one month after the intervention has ended for a follow-up assessment.
|
Wait-list Control Group
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
9
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
Baseline characteristics by cohort
| Measure |
In-Person Mindfulness-Based Cognitive Therapy
n=18 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. Participants enrolled between September 2018 and March 2020 received at least some of the intervention in-person.
|
In-Person Wait-list Control Group
n=16 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. Participants enrolled between September 2018 and March 2020 received at least some of the intervention in-person.
|
Virtual Mindfulness-Based Cognitive Therapy
n=26 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks. Participants enrolled after recruitment re-opened in September 2020 received the intervention virtually.
|
Virtual Wait-list Control Group
n=20 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments. Participants enrolled after recruitment re-opened in September 2020 received the intervention virtually.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=26 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=18 Participants
|
16 Participants
n=16 Participants
|
24 Participants
n=26 Participants
|
19 Participants
n=20 Participants
|
77 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=17 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
14 Participants
n=16 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
21 Participants
n=26 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
19 Participants
n=20 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
68 Participants
n=79 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=17 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
2 Participants
n=16 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
5 Participants
n=26 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
1 Participants
n=20 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
11 Participants
n=79 Participants • One participant in the In-Person Mindfulness-Based Cognitive Therapy study arm asked for their study data to be destroyed when they withdrew from the study.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.3 • n=18 Participants
|
44.3 years
STANDARD_DEVIATION 11.8 • n=16 Participants
|
43.54 years
STANDARD_DEVIATION 13.78 • n=26 Participants
|
45.45 years
STANDARD_DEVIATION 14.09 • n=20 Participants
|
44.81 years
STANDARD_DEVIATION 12.98 • n=80 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
16 Participants
n=16 Participants
|
26 Participants
n=26 Participants
|
20 Participants
n=20 Participants
|
80 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Baseline through Follow-up (1 month after the end of the 8-week intervention)Retention rates were assessed using session attendance. Previous mindfulness-based stress reduction (MBSR) interventions among low-income minority populations have yielded completion rates of 53-80%. Based on 80% completion rates of MBSR in primary care and 75% completion rates of MBCT both in combat vet samples and the anticipated improved accessibility through primary care, it is expected that subjects in the intervention group will evidence at least 75% retention and follow-up rates.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=44 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Number of Participants Retained in Study
|
22 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Week 8 (post-intervention assessment)Population: This analysis includes participants in the MBCT study arm who completed the Post-Intervention Assessment (25 participants) and who completed this questionnaire. Three participants had missing CSQ data due to an error where the questionnaire was not administered at this time-point.
Feasibility and acceptability of the Mindfulness-Based Cognitive Therapy intervention was assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item questionnaire asking respondents to rate the quality of care they received on a scale from 1 to 4 where 1 = poor and 4 = excellent. Total raw scores range from 8 to 32 where higher values indicate greater satisfaction.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=22 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ) Score
|
30.36 score on a scale
Standard Deviation 2.01
|
—
|
PRIMARY outcome
Timeframe: Week 8 (post-intervention assessment)Population: This analysis includes participants who completed the post-intervention assessment. Two participants in the Wait-list Control Group do not have data for the PBPT due to an error in not administering the instrument.
Barriers to treatment was assessed using the Perceived Barriers to Psychological Treatment (PBPT) scale. The PBPT is a 25-item scale asking respondents about factors that interfere with attending weekly therapy. Items are rated on a 5-point scale where 1 = impossible to attend and 5 = not a problem. Total raw scores range from 25 to 125 where higher scores indicate low barriers regarding attending psychotherapy.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=25 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=31 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Perceived Barriers to Psychological Treatment (PBPT) Scale Score
|
48.23 score on a scale
Standard Deviation 15.60
|
53.70 score on a scale
Standard Deviation 18.04
|
PRIMARY outcome
Timeframe: Baseline, Weeks 3, 5, 7, 8 (post-intervention assessment), and Follow-up (1 month after the end of the intervention)Population: One participant in MBCT requested all data removed so baseline score was unavailable; 1 participant in MBCT and 2 participants in Wait-list Control (WLC) had multiple missing self-report measures at baseline due to interviewer error. Missing data at Weeks 3, 5, and 7 were related to a participant not present at group or unable to be reached for the assessment component. The DERS was not administered to the WLC group at Weeks 3 and 7.
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item instrument assessing emotion dysregulation and includes six subscales (non-acceptance of emotions, difficulty with goal-directed behavior in the presence of negative emotions, difficulty controlling impulses in the presence of negative emotions, lack of awareness of emotions, limited use of effective emotion regulation strategies, and lack of understanding of emotions). Responses are scaled from 1 (almost never) to 5 (almost always). Total raw scores range from 36 to 180; certain items are reverse scored so that higher scores indicate increased difficulty with emotion regulation.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=42 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=34 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Difficulties in Emotion Regulation Scale (DERS) Score
Baseline
|
78.05 score on a scale
Standard Deviation 21.09
|
83.77 score on a scale
Standard Deviation 23.60
|
|
Difficulties in Emotion Regulation Scale (DERS) Score
Week 3
|
77.08 score on a scale
Standard Deviation 20.78
|
—
|
|
Difficulties in Emotion Regulation Scale (DERS) Score
Week 5
|
73.46 score on a scale
Standard Deviation 25.17
|
83.03 score on a scale
Standard Deviation 25.71
|
|
Difficulties in Emotion Regulation Scale (DERS) Score
Week 7
|
73.17 score on a scale
Standard Deviation 21.70
|
—
|
|
Difficulties in Emotion Regulation Scale (DERS) Score
Week 8
|
71.24 score on a scale
Standard Deviation 26.55
|
73.55 score on a scale
Standard Deviation 24.36
|
|
Difficulties in Emotion Regulation Scale (DERS) Score
Follow-up one month after end of intervention
|
73.00 score on a scale
Standard Deviation 25.70
|
80.56 score on a scale
Standard Deviation 29.78
|
PRIMARY outcome
Timeframe: Week 8 (post-intervention assessment)Population: This analysis includes participants receiving the MBCT intervention, either in-person or virtually, who attended the post-intervention assessment and responded to this question.
Participants randomized to the MBCT intervention completed an open-ended, follow-up questionnaire designed to assess feelings and changes experienced from participation in the intervention. Participants were asked "Have you noticed any changes in how you experience emotions or handle stressful situations?". Responses were given in text form rather than on a pre-set scale, and were then categorized as positive change, no change, or negative change.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=15 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=13 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire
Negative change
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire
Positive change
|
15 Participants
|
11 Participants
|
|
Number of Participants Reporting Change in Experience of Emotions or Handling Stressful Situations in Post-group Follow-up Questionnaire
No change
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment)Population: 8 MBCT and 8 WLC participants do not have usable baseline data due to a missing measurement, noise/error in output, iPad malfunction, or request for data removal. 2 MBCT participants and 7 WLC participants do not have Week 8 data because it was unusable due to noise/error in output. 3 MBCT participants and 1 WLC participants missed SC data collection at Week 8 due to onset of the COVID-19 pandemic and 2 WLC participants were missing SC data collection at Week 8 due to iPad malfunction.
Skin conductance (SC) response was measured among participants receiving the in-person intervention using a mobile SC device, eSense (Mindfield Biosystems). Continuous recording of SC is measured with electrodes on hands and data is transmitted through the eSense app. Using the PhenX Toolkit protocol, a two minute baseline measure of SC will be obtained and then SC levels were measured during administration of the Standardized Trauma Interview immediately following to determine physiological reactivity to trauma stimuli. SC response is calculated by subtracting SC level at the end of baseline recording (average of last 30 seconds) from the maximum SC level value during the trauma interview.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=10 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=8 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Skin Conductance Among In-Person Intervention Participants
Baseline
|
1.39 µSiemens (µS)
Standard Deviation 1.60
|
1.29 µSiemens (µS)
Standard Deviation 1.77
|
|
Skin Conductance Among In-Person Intervention Participants
Week 8
|
1.07 µSiemens (µS)
Standard Deviation 1.22
|
0.62 µSiemens (µS)
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery.
The Primary Care PTSD Screen (PC-PTSD) is a 5-item screen designed for use in primary care used to assess for presence of PTSD symptoms and serve as PTSD screener. Respondents answer "yes" or "no" to each question and an individual is considered to have PTSD if they respond with "yes" to at least 3 of the 5 questions.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=43 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination
Baseline
|
43 Participants
|
36 Participants
|
|
Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination
Week 8
|
16 Participants
|
21 Participants
|
|
Number of Participants With PTSD by Primary Care PTSD Screen (PC-PTSD) Determination
Follow-up
|
10 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery.
The Patient Health Questionnaire-9 (PHQ-9) will assess for presence of depressive symptoms and serve as a major depressive disorder (MDD) screening tool. The PHQ-9 is a 9-item tool that asks respondents to indicate how frequently they have felt symptoms of depression on a scale of 0 to 3 where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27, where higher scores indicate worse depression.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=43 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9) Score
Baseline
|
17.35 score on a scale
Standard Deviation 4.71
|
18.67 score on a scale
Standard Deviation 4.06
|
|
Patient Health Questionnaire-9 (PHQ-9) Score
Week 8
|
13.30 score on a scale
Standard Deviation 8.09
|
13.64 score on a scale
Standard Deviation 6.17
|
|
Patient Health Questionnaire-9 (PHQ-9) Score
Follow-up
|
12.47 score on a scale
Standard Deviation 6.95
|
14.22 score on a scale
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Baseline data for 1 MBCT participant and 1 WLC participant was missing due to interviewer error. Additional missing data at Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery.
The PCL-5 is a 20-item questionnaire asking respondents to report how much they have been bothered by problems in the past month on a scale of 0 (not at all) to 4 (extremely). Total scores range from 0 to 80 where higher scores indicate increased difficulty with responses to stressful experiences.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=42 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=35 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
Baseline
|
49.12 score on a scale
Standard Deviation 14.07
|
54.86 score on a scale
Standard Deviation 11.73
|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
Week 8
|
34.91 score on a scale
Standard Deviation 20.17
|
37.41 score on a scale
Standard Deviation 18.60
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Baseline data for 3 MBCT participants were also missing due to interviewer error. Additional missing data at Week 8 were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery.
The BDI-II is a 21-item instrument asking respondents to indicate how much they are bothered by negative feelings. Responses are on a scale of 0 to 3 where 0 = the problematic feeling is not present and 3 = the feeling is very strong. Total scores range from 0 to 63, where high scores indicate worse problems with negative feelings.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=40 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II) Score
Week 8
|
24.94 score on a scale
Standard Deviation 14.25
|
25.16 score on a scale
Standard Deviation 13.81
|
|
Beck Depression Inventory-II (BDI-II) Score
Baseline
|
33.80 score on a scale
Standard Deviation 11.13
|
36.39 score on a scale
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable.
The Clinician Administered PTSD Scale is a semi-structured interview used for diagnosing PTSD. The number of participants diagnosed with PTSD pre- and post-intervention will be compared between study arms.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=43 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale
Baseline
|
32 Participants
|
21 Participants
|
|
Number of Participants Diagnosed With PTSD Using the Clinician Administered PTSD Scale
Week 8
|
9 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable.
The Mini International Neuropsychiatric Interview (MINI) is a semi-structured interview used for diagnosing MDD. The number of participants diagnosed with MDD pre- and post-intervention will be compared between study arms.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=43 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Mini International Neuropsychiatric Interview (MINI) MDD Determination
Baseline
|
26 Participants
|
23 Participants
|
|
Mini International Neuropsychiatric Interview (MINI) MDD Determination
Week 8
|
12 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Baseline, and Week 8 were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery.
The Five Facet Mindfulness Questionnaire is a 39-item instrument assessing mindfulness, and includes five facets (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Participants respond to each item on a scale of 1 to 5 where 1 = the statement is never or very rarely true for them and 5 = the statement is very often or always true. Total raw scores range from 39 to 195; certain items are reverse scored so that higher scores indicate increased mindfulness.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=42 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=31 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Score
Baseline
|
119.81 score on a scale
Standard Deviation 19.82
|
122.39 score on a scale
Standard Deviation 21.40
|
|
Five Facet Mindfulness Questionnaire Score
Week 8
|
124.35 score on a scale
Standard Deviation 30.68
|
122.46 score on a scale
Standard Deviation 22.16
|
|
Five Facet Mindfulness Questionnaire Score
Follow-up
|
130.14 score on a scale
Standard Deviation 24.13
|
121.15 score on a scale
Standard Deviation 24.21
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (post-intervention assessment), Follow-up (1 month after the end of the intervention)Population: 1 participant in the MBCT condition requested all data removed so baseline score was unavailable. Additional missing data at Baseline, Week 8 and Follow-up were due to interviewer error in not asking all the self-report questions or if a participant ran out of time and ended the assessment early and was unable to be reached at a later time to finish the assessment battery.
The Self Compassion Scale is a 12-item instrument assessing how respondents typically act towards themselves during difficult times. Items are answered on a scale of 1 to 5 where 1 = almost never and 5 = almost always. Total scores range from 12 to 60; certain items are reversed scored so that higher scores indicate increased self compassion.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=39 Participants
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=29 Participants
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Self Compassion Scale, Short Form Score
Baseline
|
31.44 score on a scale
Standard Deviation 8.01
|
32.45 score on a scale
Standard Deviation 8.15
|
|
Self Compassion Scale, Short Form Score
Week 8
|
35.42 score on a scale
Standard Deviation 10.86
|
33.68 score on a scale
Standard Deviation 12.59
|
|
Self Compassion Scale, Short Form Score
Follow-up
|
34.65 score on a scale
Standard Deviation 10.86
|
34.04 score on a scale
Standard Deviation 12.59
|
Adverse Events
Mindfulness-Based Cognitive Therapy
Wait-list Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness-Based Cognitive Therapy
n=44 participants at risk
Participants randomized to receive Mindfulness-Based Cognitive Therapy (MBCT) for 8 weeks.
|
Wait-list Control Group
n=36 participants at risk
Participants randomized to the wait-list control study arm were administered the study assessments while not receiving active treatment. Participants were given the opportunity to participate in the MBCT intervention following completion of the study assessments.
|
|---|---|---|
|
Psychiatric disorders
Mood symptom increase
|
4.5%
2/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
5.6%
2/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Psychiatric disorders
Anxiety symptom increase
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Infections and infestations
Coronavirus Disease 2019 (COVID-19)
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Injury, poisoning and procedural complications
Work related physical injury
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Reproductive system and breast disorders
Prolonged menstrual bleeding related to birth control pill
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Surgical and medical procedures
Stitches on toe
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lump in armpit
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Musculoskeletal and connective tissue disorders
Worsening arthritis
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
General disorders
Worsening chronic pain
|
4.5%
2/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
General disorders
Headache
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Eye disorders
Eye dryness/irritation
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Cardiac disorders
Chest pain
|
2.3%
1/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
0.00%
0/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
|
Hepatobiliary disorders
Chronic liver dysfunction diagnosis
|
0.00%
0/44 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
2.8%
1/36 • Information on adverse events was collected at all assessment and session visits with study participants following baseline assessment and continued through the follow-up assessment occurring one month after the end of the intervention (or WLC condition). All adverse event data during study participation is included below. WLC participants were eligible to participate in the MBCT group after study participation but adverse events were not monitored for those individuals post study completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place