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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AT011342-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-as-Usual (TAU) | Active Comparator | TAU consists of weekly outpatient-based group therapy |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment-as-Usual (TAU) | Behavioral | TAU consists of weekly outpatient-based group therapy for substance use disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 Church street | New Haven | Connecticut | 06511 | United States |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Treatment-as-Usual (TAU) | TAU consists of weekly outpatient-based group therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Treatment-as-Usual (TAU) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 8-week treatment period that begins on the day participants are randomized |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corey Roos, Ph.D. | Yale School of Medicine | 203-623-5882 | corey.roos@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2023 | Jan 15, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2023 | Jan 15, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2023 | Jan 15, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Digital Mindfulness Treatment | Behavioral | The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder |
|
| Ratings made at the post-treatment assessment, which is approximately 9 weeks after 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. | 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. | 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. | 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) |
TAU consists of weekly outpatient-based group therapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Sex/Gender, Customized | Sex/Gender | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Number of participants on public assistance | Count of Participants | Participants |
|
| Number of participants referred by criminal justice system | Count of Participants | Participants |
|
| Primary substance used | Count of Participants | Participants |
|
| Number of participants that use two or more substances | Count of Participants | Participants |
|
| Severity of Substance Use Disorder (SUD) diagnosis | Count of Participants | Participants |
|
| Number of participants currently enrolled in Intensive Outpatient Program (IOP) for SUD | Count of Participants | Participants |
|
| Number of participants currently enrolled in outpatient relapse prevention groups for SUD | Count of Participants | Participants |
|
| Mean number of previous residential treatments for SUD | Mean | Standard Deviation | treaments |
|
| Mean number of previous outpatient treatments for SUD | Mean | Standard Deviation | treatments |
|
|
|
| Primary | Completion Rates for the Post-treatment Assessment Visit | Percentage of participants that completed post-treatment assessment visit of all randomized participants | Posted | Count of Participants | Participants | Approximately 9 weeks after randomization |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 2-month post-treatment follow-up (approximately 16 weeks post-randomization) |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 2-week period at baseline prior to randomization |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Post-treatment during weeks 10 and 11 post-randomization |
|
|
|
| Secondary | 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. | Participants that completed assessments at each time point were analyzed. | Posted | Mean | 95% Confidence Interval | Change in % days of any substance use | 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) |
|
|
|
|
| Secondary | 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. | Participants that completed assessments at each time point were analyzed. | Posted | Mean | 95% Confidence Interval | Change in % days primary substance use | 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) |
|
|
|
|
| Secondary | 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. | Participants that completed assessments at each time point were analyzed. | Posted | Mean | 95% Confidence Interval | Change in total score on SIP-R | 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) |
|
|
|
|
| Secondary | 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. | Participants that completed assessments at each time point were analyzed. | Posted | Mean | 95% Confidence Interval | Change in BSI total score | 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) |
|
|
|
|
| Primary | 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. | Participants that completed the assessment were analyzed. This outcome was only collected for the digital mindfulness arm. | Posted | Mean | Standard Deviation | score | Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Treatment-as-Usual (TAU) | TAU consists of weekly outpatient-based group therapy | 0 | 16 | 0 | 16 | 0 | 16 |
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| Baseline to 2-month follow-up |
|
|
Change in percent days of any substance use from Baseline to end of treatment
| Paired samples t test |
| .47 |
| Mean Difference (Final Values) |
| 5.97 |
| Standard Deviation |
| 24.94 |
| 2-Sided |
| 95 |
| -10.49 |
| 21.19 |
| Other |
Within-treatment-condition evaluation of changes over time |
| Change in percent days of any substance use from baseline to 2-month follow-up | Paired samples t-test | .018 | Mean Difference (Final Values) | 20.2 | Standard Deviation | 19.12 | 2-Sided | 95 | 3.25 | 27.56 | Other | Within-treatment-condition evaluation of changes over time |
| Change in percent days of any substance use from baseline to 2-month follow-up | Paired Samples T-test | .42 | Mean Difference (Final Values) | 4.29 | Standard Deviation | 42.24 | 2-Sided | 95 | -10.50 | 34.43 | Other | Within-treatment-condition evaluation of changes over time |
| Baseline to 2-month follow-up |
|
|
Change in percent days of primary substance use from baseline to end of treatment
| Paired Samples T-test |
| .36 |
| Mean Difference (Final Values) |
| 5.97 |
| Standard Deviation |
| 21.68 |
| 2-Sided |
| 95 |
| -7.81 |
| 19.74 |
| Other |
Within-treatment-condition evaluation of changes over time |
| Change in percent days of primary substance use from baseline to 2-month follow-up | Paired Samples T-test | .07 | Mean Difference (Final Values) | 12.15 | Standard Deviation | 15.23 | 2-Sided | 95 | -1.11 | 18.23 | Other | Within-treatment-condition evaluation of changes over time |
| Change in percent days of primary substance use from baseline to 2-month follow-up | Paired Samples T-test | .59 | Mean Difference (Final Values) | 4.29 | Standard Deviation | 16.26 | 2-Sided | 95 | -9.50 | 15.49 | Other | Within-treatment-condition evaluation of changes over time |
| Baseline to 2-month follow-up |
|
|
Change in SIP score (substance-related problems) from baseline to end of treatment
| Paired samples t test |
| .001 |
| Mean Difference (Final Values) |
| 1.13 |
| Standard Deviation |
| .85 |
| 95 |
| .64 |
| 1.86 |
| Other |
Within-treatment-condition evaluation of changes over time |
| Change in SIP score (substance-related problems) from baseline to 2-month follow-up | Paired samples t test | .04 | Mean Difference (Final Values) | .76 | Standard Deviation | .60 | 2-Sided | 95 | .27 | 1.08 | Other | Within-treatment-condition evaluation of changes over time |
| Change in SIP score (substance-related problems) from baseline to 2-month follow-up | Paired Samples T-test | .054 | Mean Difference (Final Values) | .79 | Standard Deviation | 1.13 | 2-Sided | 95 | -.01 | 1.60 | Other | Within-treatment-condition evaluation of changes over time |
| Baseline to 2-month follow-up |
|
|
Change in BSI score (psychological distress) from baseline to end of treatment
| Paired Samples T-test |
| .01 |
| Mean Difference (Final Values) |
| .57 |
| Standard Deviation |
| .56 |
| 2-Sided |
| 95 |
| .17 |
| .97 |
| Other |
Within-treatment-condition evaluation of changes over time |
| Change in BSI score (psychological distress) from baseline to 2-month follow-up | Paired Samples T-test | .10 | Mean Difference (Final Values) | .47 | Standard Deviation | .23 | 2-Sided | 95 | -.10 | 1.10 | Other | Within-treatment-condition evaluation of changes over time |
| Change in BSI score (psychological distress) from baseline to 2-month follow-up | Paired samples t test | .10 | Mean Difference (Final Values) | .35 | Standard Deviation | .77 | 95 | -.11 | .99 | Other | Within-treatment-condition evaluation of changes over time |
| Title | Measurements |
|---|---|
|
| Engage-ability |
|
| Visual Appeal |
|
| Helpfulness |
|
| Perceived Skill Acquisition |
|
| Confidence Implementing Skills |
|