Clinical trial NCT05094440: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Substance Use Disorders
Keywords: dialectical behavior therapy, digital health
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University of Missouri, St. Louis
First posted: 2021-10-26
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Severity of Dependence Scale
timeFrame: 30 days
Secondary outcomes:
measure: Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
timeFrame: 14 days
measure: Generalized Anxiety Disorder-7 (GAD-7) Scale
timeFrame: 14 days
measure: Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
timeFrame: 30 days
measure: WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
timeFrame: 30 days
measure: Mindful Attention and Awareness Scale (MAAS)
timeFrame: 30 days
measure: Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)
timeFrame: 30 days
measure: Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)
timeFrame: 30 days
measure: NIDA Assist
timeFrame: 30 days
measure: Daily Drinking Questionnaire (DDQ)
timeFrame: 30 days
Other outcomes:
measure: Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)
timeFrame: 8 weeks
measure: Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
timeFrame: 30 days
Locations:
city: Toronto
country: Canada
facility: Campbell Family Mental Health Research Institute
state: Ontario
Study officials:
affiliation: Campbell Family Mental Health Research Institute, CAMH
name: Lena C. Quilty, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: