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A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use

Primary Purpose

Alcohol Use Disorder, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dialectical behavioral therapy skills training (DBT-ST)
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring dialectical behavior therapy, digital health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-65 years of age
  2. Fluency in English
  3. Understanding and willingness to comply with study requirements
  4. Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services
  5. Smartphone, tablet, or computer with access to the Internet
  6. Reports at least "contemplation" levels of wanting to reduce substance use
  7. Use of target substance in past month
  8. Alcohol or substance use disorder in the past year

Exclusion Criteria:

  1. Any known practical factor that would preclude participation (e.g., extended absences)
  2. Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis)
  3. Participation in another treatment/intervention study

Sites / Locations

  • Campbell Family Mental Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Treatment

Waitlist and Delayed Treatment

Arm Description

Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app intervention will be primarily monitored for one month, but followed for up to 3 months, and will be supplemented with a walk through manual and links to DBT worksheets. The intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program or greater community.

Waitlist control whereby outpatients or members of the community will wait 1 month (4 weeks) to receive the intervention and then receive the Pocket Skills webapp for the subsequent 2 months (8 weeks). The waitlist period and subsequent intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program.

Outcomes

Primary Outcome Measures

Severity of Dependence Scale
Level of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.

Secondary Outcome Measures

Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
Level of depressive symptoms over the past 14 days. Minimum score: 0, maximum score 27. Higher scores mean worse outcome.
Generalized Anxiety Disorder-7 (GAD-7) Scale
Level of generalized anxiety symptoms over the past 14 days. Minimum score: 0, maximum score 21. Higher scores mean worse outcome.
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
Level of emotion dysregulation or the difficulty in changing unwanted emotions effectively in the past month. Minimum score: 18, maximum score 90. Higher scores mean worse outcome.
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
Level of functional disability in the past month. Minimum score: 0, maximum score 48. Higher scores mean worse outcome.
Mindful Attention and Awareness Scale (MAAS)
Measure of core mindfulness skills around awareness and acceptance, over the past month. Minimum score: 0, maximum score 6 (mean score on 15 items). Higher scores indicate more positive outcome (e.g., more mindful awareness).
Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)
Measure of suicidal ideation and behaviors over the past month. Minimum score: 3, maximum score: 18. Higher scores indicate worse outcome.
Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)
Measure of risky and impulsive behavior, past month. Only subscales pertaining to sexual behavior and general reckless behavior will be used. Minimum score: 0, Maximum score: 40. Higher scores indicate worse outcome (e.g., more impulsive and/or risky behaviors)
NIDA Assist
Assesses the frequency of non-alcohol substance use over the past month. Minimum score per item: never used substance; maximum score per item: used substance daily or almost daily. Higher scores indicate worse outcome (e.g., more substance use).
Daily Drinking Questionnaire (DDQ)
Assesses the frequency and quantity of alcohol use and binge drinking episodes over the past month. Minimum score: no alcoholic drinks on specific day; Maximum score: 15+ drinks on a specific day. Higher scores indicate worse outcome (E.g., more alcoholic drinks consumed).

Full Information

First Posted
October 14, 2021
Last Updated
September 13, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
University of Missouri, St. Louis
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1. Study Identification

Unique Protocol Identification Number
NCT05094440
Brief Title
A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use
Official Title
Feasibility, Acceptability, and Efficacy of a Dialectical Behavioral Therapy Digital Health Solution in the CAMH Rainbow/COMPASS Service
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University of Missouri, St. Louis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention (e.g., a waitlist control condition).
Detailed Description
Seventy adult outpatients and community members seeking treatment for substance use from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive immediate or delayed (1 month) access to a web-based DBT skills training intervention called Pocket Skills in addition to standard care. Participants will complete interviews and questionnaires at baseline. Following baseline, participants complete questionnaires at months 1, 2, and 3 months. Measures will assess alcohol and drug consumption, substance use disorder symptoms, and other clinical features.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Substance Use Disorders
Keywords
dialectical behavior therapy, digital health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app intervention will be primarily monitored for one month, but followed for up to 3 months, and will be supplemented with a walk through manual and links to DBT worksheets. The intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program or greater community.
Arm Title
Waitlist and Delayed Treatment
Arm Type
Active Comparator
Arm Description
Waitlist control whereby outpatients or members of the community will wait 1 month (4 weeks) to receive the intervention and then receive the Pocket Skills webapp for the subsequent 2 months (8 weeks). The waitlist period and subsequent intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavioral therapy skills training (DBT-ST)
Other Intervention Name(s)
Pocket Skills
Intervention Description
Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app will occur primarily over 1 month, followed by 2 months of follow-up, and will be supplemented with a walk through manual and links to DBT worksheets.
Primary Outcome Measure Information:
Title
Severity of Dependence Scale
Description
Level of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
Description
Level of depressive symptoms over the past 14 days. Minimum score: 0, maximum score 27. Higher scores mean worse outcome.
Time Frame
14 days
Title
Generalized Anxiety Disorder-7 (GAD-7) Scale
Description
Level of generalized anxiety symptoms over the past 14 days. Minimum score: 0, maximum score 21. Higher scores mean worse outcome.
Time Frame
14 days
Title
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
Description
Level of emotion dysregulation or the difficulty in changing unwanted emotions effectively in the past month. Minimum score: 18, maximum score 90. Higher scores mean worse outcome.
Time Frame
30 days
Title
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
Description
Level of functional disability in the past month. Minimum score: 0, maximum score 48. Higher scores mean worse outcome.
Time Frame
30 days
Title
Mindful Attention and Awareness Scale (MAAS)
Description
Measure of core mindfulness skills around awareness and acceptance, over the past month. Minimum score: 0, maximum score 6 (mean score on 15 items). Higher scores indicate more positive outcome (e.g., more mindful awareness).
Time Frame
30 days
Title
Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)
Description
Measure of suicidal ideation and behaviors over the past month. Minimum score: 3, maximum score: 18. Higher scores indicate worse outcome.
Time Frame
30 days
Title
Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)
Description
Measure of risky and impulsive behavior, past month. Only subscales pertaining to sexual behavior and general reckless behavior will be used. Minimum score: 0, Maximum score: 40. Higher scores indicate worse outcome (e.g., more impulsive and/or risky behaviors)
Time Frame
30 days
Title
NIDA Assist
Description
Assesses the frequency of non-alcohol substance use over the past month. Minimum score per item: never used substance; maximum score per item: used substance daily or almost daily. Higher scores indicate worse outcome (e.g., more substance use).
Time Frame
30 days
Title
Daily Drinking Questionnaire (DDQ)
Description
Assesses the frequency and quantity of alcohol use and binge drinking episodes over the past month. Minimum score: no alcoholic drinks on specific day; Maximum score: 15+ drinks on a specific day. Higher scores indicate worse outcome (E.g., more alcoholic drinks consumed).
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)
Description
Whether or not the treatment is seen as acceptable and helpful with respect to current symptoms/problems. Minimum score: 6, maximum score: 42. Higher scores indicate better treatment acceptability and positive perceptions of the treatment.
Time Frame
8 weeks
Title
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
Description
Measure of treatment credibility and expectancy for interventions. Minimum score: 4; Maximum score: 56; Higher scores mean participants perceive the intervention to provide expected benefits and/or improvements.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age Fluency in English Understanding and willingness to comply with study requirements Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services Smartphone, tablet, or computer with access to the Internet Reports at least "contemplation" levels of wanting to reduce substance use Use of target substance in past month Alcohol or substance use disorder in the past year Exclusion Criteria: Any known practical factor that would preclude participation (e.g., extended absences) Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis) Participation in another treatment/intervention study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C. Quilty, Ph.D.
Organizational Affiliation
Campbell Family Mental Health Research Institute, CAMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campbell Family Mental Health Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://camh.ca/research
Description
Information about research at the Centre for Addiction and Mental Health
URL
https://camhstudies.ca/cgi-bin/findCAMHstudy_study.php?d=1331
Description
Study webpage

Learn more about this trial

A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use

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