Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treatment-as-Usual (TAU)

Digital Mindfulness Treatment

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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

Sites / Locations

1 Church streetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment-as-Usual (TAU)

TAU Plus Digital Mindfulness-Based Treatment

Arm Description

TAU consists of weekly outpatient-based group therapy

TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.

Outcomes

Primary Outcome Measures

Adherence to the digital treatment

Percent of randomized participants completing 50% or more of the digital treatment modules

Completion rates for the post-treatment assessment visit

Percent of randomized participants completing post-treatment assessment visit

Completion rates for the follow-up assessment visit

Percent of randomized participants completing follow-up assessment visit

Completion rates for ecological momentary assessment at baseline

Percent of randomized participants completing 50% or more of EMA surveys at baseline

Completion rates for ecological momentary assessment at post-treatment

Percent of randomized participants completing 50% or more of EMA surveys post-treatment

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05852015

First Posted

April 17, 2023

Last Updated

May 19, 2023

Sponsor

Yale University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT05852015

Brief Title

Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

Official Title

Digital Mindfulness-Based Treatment for Individuals in Early Recovery From Substance Use Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 18, 2023 (Actual)

Primary Completion Date

May 1, 2025 (Anticipated)

Study Completion Date

May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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. The digital treatment will be completed over an 8-week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment-as-Usual (TAU)

Arm Type

Active Comparator

Arm Description

TAU consists of weekly outpatient-based group therapy

Arm Title

TAU Plus Digital Mindfulness-Based Treatment

Arm Type

Experimental

Arm Description

TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.

Intervention Type

Behavioral

Intervention Name(s)

Treatment-as-Usual (TAU)

Intervention Description

TAU consists of weekly outpatient-based group therapy for substance use disorder

Intervention Type

Behavioral

Intervention Name(s)

Digital Mindfulness Treatment

Intervention Description

The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder

Primary Outcome Measure Information:

Title

Adherence to the digital treatment

Description

Percent of randomized participants completing 50% or more of the digital treatment modules

Time Frame

8-week treatment period that begins on the day participants are randomized

Title

Completion rates for the post-treatment assessment visit

Description

Percent of randomized participants completing post-treatment assessment visit

Time Frame

Approximately 9 weeks after randomization

Title

Completion rates for the follow-up assessment visit

Description

Percent of randomized participants completing follow-up assessment visit

Time Frame

2-month post-treatment follow-up (approximately 16 weeks post-randomization)

Title

Completion rates for ecological momentary assessment at baseline

Description

Percent of randomized participants completing 50% or more of EMA surveys at baseline

Time Frame

2-week period at baseline prior to randomization

Title

Completion rates for ecological momentary assessment at post-treatment

Description

Percent of randomized participants completing 50% or more of EMA surveys post-treatment

Time Frame

2-week period occurring approximately during weeks 10 and 11 post-randomization

Title

Dimensions of treatment acceptability

Description

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.

Time Frame

Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization

Other Pre-specified Outcome Measures:

Title

Change in frequency of primary substance use

Description

The Timeline Follow Back, a calendar-based interview, will be used to assess 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)

Title

Change in frequency of any substance use

Description

The Timeline Follow Back, a calendar-based interview, will be used to assess 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)

Title

Change in substance-related problems

Description

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.

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Corey Roos

Phone

2036235882

Email

corey.roos@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Hedy Kober

Phone

917-470-8331

Email

hedy.kober@yale.edu

Facility Information:

Facility Name

1 Church street

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Corey Roos, PhD

Phone

203-623-5882

Email

corey.roos@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Substance Use Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial