ACT for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals

NCT05334914 | Not Yet Recruiting

• 1 other identifier: CAMH CCI ACT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the feasibility, acceptability and preliminary effectiveness of Acceptance Commitment Therapy, in conjunction with motivation enhancement, and the use of the ChillTime App, in reducing methamphetamine use in women with MUD with or without co-occurring psychiatric disorders. This intervention is designed to be delivered remotely (e.g., participants can complete the entire study from home), with the option for in person attendance if it is not feasible or safe for participants to attend from home.

Conditions

Methamphetamine Abuse; Methamphetamine-dependence

Keywords

Methamphetamine use disorder; Acceptance commitment therapy; Contingency management; Motivational interviewing; App-based interventions; Telehealth; Women; Gender Non-Conforming; Non-binary

Outcome Measures

Primary Outcomes (2)

• Feasibility of intervention

  Rates of eligible participants who agree to participate in the study intervention; Rates of retention in program (e.g., number of participants that completed all 15 sessions, number of participants that completed at least a full dose of 10 sessions, number of participants that dropped out before 10 sessions); Rate of use of ChillTime App

  Immediately after intervention

• Acceptability of intervention

  Acceptance and understanding of the program using qualitative assessments at the end of study and the Client Satisfaction Questionnaire

  1 month follow-up

Secondary Outcomes (12)

• Changes in methamphetamine use via the timeline followback (TLFB)

  Baseline, immediately after intervention, 1 month follow-up

• Changes in methamphetamine use via urinalysis

  Baseline, immediately after intervention, 1 month follow-up

• Changes in other substance use via the Timeline Followback (TLFB)

  Baseline, immediately after intervention, 1 month follow-up

• Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, immediately after intervention, 1 month follow-up

• Changes in depression via the Patient Health Questionnaire-9 (PHQ-9)

  Baseline, immediately after intervention, 1 month follow-up

Study Arms (1)

Intervention Arm

OTHER

Participants will complete the baseline session, a 1:1 motivation building session, and 8 weeks of ACT group therapy. They will then complete a final study visit and a follow-up study visit to occur 6 month after the end of therapy.

Behavioral: Acceptance Commitment Therapy

Interventions

Acceptance Commitment Therapy BEHAVIORAL

ACT: Consists of 15 sessions, twice per week. Each session is approximately 2.5 hours including breaks. Clients cover 3 modules (OPEN, ACTIVE, AWARE). Any participant who requires access to a device for any part of the study will be provided with one for the duration of the study. CM: Participants will be given progressive compensation for session attendance via gift cards or e-gift cards amounting to $520. Motivation Building Session: The study clinician will meet with each of the participants to explain the process of the therapy, reinforce expectations, and address any concerns or hesitations, and build motivation and commitment to fully engage in the program. ChillTime App Participants rate their emotional state and choose a coping strategy (either physical, emotional, cognitive or spiritual). The app's algorithm learns the individual's strategy preferences over time, allowing for more personalized suggestions. Participants are also able to access coping strategies ad hoc.

Also known as: Contingency Management, Motivation Building, App-Based Therapy

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as female, woman, or non-binary and is comfortable participating in a women's group
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet SCID DSM-5 criteria for Methamphetamine Use Disorder
• Over the age of 18
• Female, woman, or non-binary and comfortable participating in women's group
• Capacity to provide informed consent
• Adequate English language abilities

You may not qualify if:

• Experiencing acute or unmedicated psychosis that would reasonably prevent them from engaging in and/or benefiting from the intervention
• Experiencing acute and severe suicidal ideation such that institutionalization and supervised care is warranted
• Experiencing severe cognitive deficits that would reasonably prevent them from consenting, engaging in, and/or benefiting from the intervention

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bernard Le Foll, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Sabioni, PhD

CONTACT

4165358501; ACTforMUD@camh.ca; pamela.sabioni@camh.ca

Harminder Paul

CONTACT

4165358501; harminder.paul@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Single-arm, open-label, feasibility trial

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 19, 2022
• Study Start: March 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)