Trial Outcomes & Findings for Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery (NCT NCT05852015)
NCT ID: NCT05852015
Last Updated: 2026-06-17
Results Overview
Percentage of participants that completed post-treatment assessment visit of all randomized participants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Approximately 9 weeks after randomization
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
|
Overall Study
Completed mid-treatment visit
|
15
|
11
|
|
Overall Study
Completed post-treatment visit
|
15
|
12
|
|
Overall Study
Completed 2-month follow-up visit
|
13
|
10
|
|
Overall Study
Included in post-treatment analyses
|
15
|
12
|
|
Overall Study
Included in 2-month follow-up analyses
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery
Baseline characteristics by cohort
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=20 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=16 Participants
TAU consists of weekly outpatient-based group therapy
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.05 years
STANDARD_DEVIATION 10.05 • n=9 Participants
|
37.63 years
STANDARD_DEVIATION 9.67 • n=27 Participants
|
39.53 years
STANDARD_DEVIATION 9.89 • n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Primary substance used
Opioid Pills
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Education
Less than high school
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Education
High school or GED
|
8 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Education
Some college or Associate degree
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Education
Bachelor's degree or higher
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Woman
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Man
|
15 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Transgender man
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Employment status
Unemployed
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Employment status
Employed
|
13 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Number of participants on public assistance
|
11 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
|
Number of participants referred by criminal justice system
|
14 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
Primary substance used
Alcohol
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Primary substance used
Cocaine
|
4 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Primary substance used
Marijuana
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Primary substance used
Heroin
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Primary substance used
Hallucinogens
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Primary substance used
Dissociative Drugs
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Number of participants that use two or more substances
|
16 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Severity of Substance Use Disorder (SUD) diagnosis
Mild
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Severity of Substance Use Disorder (SUD) diagnosis
Moderate
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Severity of Substance Use Disorder (SUD) diagnosis
Severe
|
14 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
|
Number of participants currently enrolled in Intensive Outpatient Program (IOP) for SUD
|
10 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
|
Number of participants currently enrolled in outpatient relapse prevention groups for SUD
|
10 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Mean number of previous residential treatments for SUD
|
1.75 treaments
STANDARD_DEVIATION 2.95 • n=9 Participants
|
4.25 treaments
STANDARD_DEVIATION 4.85 • n=27 Participants
|
2.86 treaments
STANDARD_DEVIATION 4.05 • n=267 Participants
|
|
Mean number of previous outpatient treatments for SUD
|
4.10 treatments
STANDARD_DEVIATION 4.48 • n=9 Participants
|
3.56 treatments
STANDARD_DEVIATION 1.67 • n=27 Participants
|
3.86 treatments
STANDARD_DEVIATION 3.49 • n=267 Participants
|
PRIMARY outcome
Timeframe: 8-week treatment period that begins on the day participants are randomizedNumber of randomized participants completing 50% or more of the digital treatment modules. This outcome was only assessed in the digital mindfulness arm.
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=20 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Adherence to the Digital Treatment
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: Approximately 9 weeks after randomizationPercentage of participants that completed post-treatment assessment visit of all randomized participants
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=20 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=16 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Completion Rates for the Post-treatment Assessment Visit
|
15 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 2-month post-treatment follow-up (approximately 16 weeks post-randomization)Percentage of participants that completed 2-month post-treatment assessment visit of all randomized participants
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=20 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=16 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Completion Rates for the 2-month Follow-up Assessment Visit
|
13 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 2-week period at baseline prior to randomizationPercentage of participants that completed 50% or more of EMA surveys at baseline of all randomized participants
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=20 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=16 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Completion Rates for Ecological Momentary Assessment at Baseline
|
14 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Post-treatment during weeks 10 and 11 post-randomizationPercentage of participants that completed 50% or more of EMA surveys post-treatment of all randomized participants
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=12 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=9 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Completion Rates for Ecological Momentary Assessment Post-treatment
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomizationPopulation: Participants that completed the assessment were analyzed. This outcome was only collected for the digital mindfulness arm.
Single-items measuring ratings of acceptability dimensions for the digital treatment, including willingness to engage, usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability.
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=15 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Dimensions of Treatment Acceptability
Willingness to Engage
|
4.06 score
Standard Deviation 1.37
|
—
|
|
Dimensions of Treatment Acceptability
Usability
|
4.75 score
Standard Deviation 0.45
|
—
|
|
Dimensions of Treatment Acceptability
Understandability
|
4.50 score
Standard Deviation 0.52
|
—
|
|
Dimensions of Treatment Acceptability
Engage-ability
|
4.25 score
Standard Deviation 0.86
|
—
|
|
Dimensions of Treatment Acceptability
Visual Appeal
|
4.08 score
Standard Deviation 0.79
|
—
|
|
Dimensions of Treatment Acceptability
Helpfulness
|
4.33 score
Standard Deviation 0.88
|
—
|
|
Dimensions of Treatment Acceptability
Perceived Skill Acquisition
|
4.25 score
Standard Deviation 0.75
|
—
|
|
Dimensions of Treatment Acceptability
Confidence Implementing Skills
|
4.50 score
Standard Deviation 0.90
|
—
|
SECONDARY outcome
Timeframe: Baseline, at end-of-treatment (end of week 8 post-randomization) and at the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)Population: Participants that completed assessments at each time point were analyzed.
The Timeline Follow Back, a calendar-based interview, will be used to assess substance use. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=15 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=12 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Change in Percent Days of Any Substance Use
Baseline to post-treatment
|
14.3 Change in % days of any substance use
Interval 0.48 to 27.77
|
5.97 Change in % days of any substance use
Interval -10.49 to 21.19
|
|
Change in Percent Days of Any Substance Use
Baseline to 2-month follow-up
|
20.2 Change in % days of any substance use
Interval 3.25 to 27.56
|
4.29 Change in % days of any substance use
Interval -10.5 to 34.43
|
SECONDARY outcome
Timeframe: Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)Population: Participants that completed assessments at each time point were analyzed.
The Timeline Follow Back, a calendar-based interview, will be used to assess substance use. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=15 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=12 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Change in Percent Days of Primary Substance Use
Baseline to post-treatment
|
1.71 Change in % days primary substance use
Interval -11.46 to 14.88
|
5.97 Change in % days primary substance use
Interval -7.81 to 19.74
|
|
Change in Percent Days of Primary Substance Use
Baseline to 2-month follow-up
|
12.15 Change in % days primary substance use
Interval -1.11 to 18.23
|
4.29 Change in % days primary substance use
Interval -9.5 to 15.49
|
SECONDARY outcome
Timeframe: Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)Population: Participants that completed assessments at each time point were analyzed.
Short-inventory of problems Revised (SIP-R), a self-report questionnaire of substance-related problems. Total score range from 0 to 51, with higher scores indicating greater substance related problems. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=15 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=12 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Change in Substance-related Problems
Baseline to post-treatment
|
.78 Change in total score on SIP-R
Interval 0.25 to 1.31
|
1.13 Change in total score on SIP-R
Interval 0.64 to 1.86
|
|
Change in Substance-related Problems
Baseline to 2-month follow-up
|
.76 Change in total score on SIP-R
Interval 0.27 to 1.08
|
.79 Change in total score on SIP-R
Interval -0.01 to 1.6
|
SECONDARY outcome
Timeframe: Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)Population: Participants that completed assessments at each time point were analyzed.
BSI assesses psychiatric distress using a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Higher scores indicate more distress. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome.
Outcome measures
| Measure |
TAU Plus Digital Mindfulness-Based Treatment
n=15 Participants
TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.
|
Treatment-as-Usual (TAU)
n=12 Participants
TAU consists of weekly outpatient-based group therapy
|
|---|---|---|
|
Change in Brief Symptom Inventory (BSI) Score
Baseline to post-treatment
|
.15 Change in BSI total score
Interval -0.05 to 0.35
|
.57 Change in BSI total score
Interval 0.17 to 0.97
|
|
Change in Brief Symptom Inventory (BSI) Score
Baseline to 2-month follow-up
|
.47 Change in BSI total score
Interval -0.1 to 1.1
|
.35 Change in BSI total score
Interval -0.11 to 0.99
|
Adverse Events
TAU Plus Digital Mindfulness-Based Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment-as-Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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