Substance Use DisordersNCT05852015
Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery
A study testing Treatment-as-Usual (TAU) and Digital Mindfulness Treatment in people with Substance Use Disorders, run by Yale University at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Treatment-as-Usual (TAU) and Digital Mindfulness Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Fluent in English and have a 6th grade or higher reading level
- Have completed 1 month or more of SUD treatment
- Report use of their primary substance of choice in past 6 months
- Are not currently enrolled in residential/inpatient treatment
- Are willing to be randomized
Show all 9Show fewer
- Are willing and able to participate for the entire study period
- Are willing to provide locator information for follow-up
- Own a working, WIFI-enabled smartphone
Who cannot join
- Current psychotic disorder
- High suicide risk characterized by suicidal ideation with intent
- Homicidal ideation posing imminent danger to others
- Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period
- Participation in the Phase 1 User Testing study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders
The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.
- Conditions
- Substance Use Disorders
- Being tested
- Treatment-as-Usual (TAU), Digital Mindfulness Treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment-as-Usual (TAU)Behavioural
TAU consists of weekly outpatient-based group therapy for substance use disorder
Digital Mindfulness TreatmentBehavioural
The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-Usual (TAU) | Active comparator | TAU consists of weekly outpatient-based group therapy Receives: Behavioral: Treatment-as-Usual (TAU) |
| TAU Plus Digital Mindfulness-Based Treatment | Experimental | TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills. Receives: Behavioral: Treatment-as-Usual (TAU); Behavioral: Digital Mindfulness Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Digital Treatment
Number of randomized participants completing 50% or more of the digital treatment modules. This outcome was only assessed in the digital mindfulness arm.
Measured: 8-week treatment period that begins on the day participants are randomized
Completion Rates for the Post-treatment Assessment Visit
Percentage of participants that completed post-treatment assessment visit of all randomized participants
Measured: Approximately 9 weeks after randomization
Completion Rates for the 2-month Follow-up Assessment Visit
Percentage of participants that completed 2-month post-treatment assessment visit of all randomized participants
Measured: 2-month post-treatment follow-up (approximately 16 weeks post-randomization)
Completion Rates for Ecological Momentary Assessment at Baseline
Percentage of participants that completed 50% or more of EMA surveys at baseline of all randomized participants
Measured: 2-week period at baseline prior to randomization
Completion Rates for Ecological Momentary Assessment Post-treatment
Percentage of participants that completed 50% or more of EMA surveys post-treatment of all randomized participants
Measured: Post-treatment during weeks 10 and 11 post-randomization
Dimensions of Treatment Acceptability
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.
Measured: Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization
Secondary outcomes (4)
Change in Percent Days of Any Substance Use
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.
Measured: 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)
Change in Percent Days of Primary Substance Use
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.
Measured: 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)
Change in Substance-related Problems
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.
Measured: 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)
Change in Brief Symptom Inventory (BSI) Score
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start18 May 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852015
- Sponsor's protocol ID
- 2000028537
- Other IDs
- 1K23AT011342-01
- Status last verified
- May 2026
- First submitted
- 17 Apr 2023
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders
- ClinicalTrials.gov ID
- NCT05852015
- Acronym / sponsor ID
- 2000028537
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 18 May 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-Usual (TAU) | Active comparator | Behavioral: Treatment-as-Usual (TAU)TAU consists of weekly outpatient-based group therapy |
| TAU Plus Digital Mindfulness-Based Treatment | Experimental | Behavioral: Treatment-as-Usual (TAU), Behavioral: Digital Mindfulness TreatmentTAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Fluent in English and have a 6th grade or higher reading level
- Have completed 1 month or more of SUD treatment
- Report use of their primary substance of choice in past 6 months
- Are not currently enrolled in residential/inpatient treatment
Key exclusion criteria (5 listed)
- Current psychotic disorder
- High suicide risk characterized by suicidal ideation with intent
- Homicidal ideation posing imminent danger to others
- Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period
- Participation in the Phase 1 User Testing study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment-as-Usual (TAU)TAU consists of weekly outpatient-based group therapy for substance use disorder | Behavioural | TAU Plus Digital Mindfulness-Based Treatment, Treatment-as-Usual (TAU) |
| Digital Mindfulness TreatmentThe digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder | Behavioural | TAU Plus Digital Mindfulness-Based Treatment |
Primary outcome
Adherence to the Digital Treatment
Time frame: 8-week treatment period that begins on the day participants are randomized
Number of randomized participants completing 50% or more of the digital treatment modules. This outcome was only assessed in the digital mindfulness arm.
Completion Rates for the Post-treatment Assessment Visit
Time frame: Approximately 9 weeks after randomization
Percentage of participants that completed post-treatment assessment visit of all randomized participants
Completion Rates for the 2-month Follow-up Assessment Visit
Time frame: 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
Completion Rates for Ecological Momentary Assessment at Baseline
Time frame: 2-week period at baseline prior to randomization
Percentage of participants that completed 50% or more of EMA surveys at baseline of all randomized participants
Completion Rates for Ecological Momentary Assessment Post-treatment
Time frame: Post-treatment during weeks 10 and 11 post-randomization
Percentage of participants that completed 50% or more of EMA surveys post-treatment of all randomized participants
Dimensions of Treatment Acceptability
Time frame: Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization
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.
4 secondary outcomes
Change in Percent Days of Any Substance Use
Time frame: 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)
Change in Percent Days of Primary Substance Use
Time frame: 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)
Change in Substance-related Problems
Time frame: 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)
Change in Brief Symptom Inventory (BSI) Score
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Requests for data sharing will be considered within the context of ongoing and planned research being performed within the research group at Yale in order to avoid duplication of effort and overlap in data analysis that might compromise communication of findings. Data to be shared will be de-identified and transmission electronically and securely, as we have done previously with investigators at other institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment-as-Usual (TAU) and Digital Mindfulness Treatment in people with Substance Use Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Digital Treatment (time frame: 8-week treatment period that begins on the day participants are randomized). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.