Methamphetamine Abuse Clinical Trial
Official title:
An Online/In Person Program Assessing Acceptance Commitment Therapy Matrix Plus Contingency Management for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | April 1, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Changes in methamphetamine use via the timeline followback (TLFB) | The Timeline Followback (TLFB) is a method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of methamphetamine use over the past 7-days | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in methamphetamine use via urinalysis | Liquid chromatography/mass spectrometry will be used to provide qualitative (yes/no) assessments of presence of methamphetamine in urine | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in other substance use via the Timeline Followback (TLFB) | The Timeline Followback (TLFB) is a method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of other drug use over the past 7-days | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in depression via the Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is the nine item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 can function as a screening tool, an aid in diagnosis, and as a symptom tracking tool that can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment. | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in trauma symptoms via the Trauma Screening Questionnaire (TSQ) | The TSQ is a 10-item symptom screen that was designed for use with survivors of all types of traumatic stress. The TSQ is based on items from the PTSD Symptom Scale - Self Report (PSS-SR; Foa et al., 1993) and has five re-experiencing items and five arousal items. | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in acceptance commitment skills via the Acceptance and Action Questionnaire [AAQ-2 | This 4-item measure uses 0-4 scale (0 = Not at All True; 4 = Very True) with lower sores correlating with higher psychological flexibility. | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in cravings/urges for methamphetamine via the Brief Substance Craving Scale BSCS | The BSCS is a 16 item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. Intensity and frequency of craving are recorded on a five-point Likert scale | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Changes in quality of life, including well-being, relationships, social activities, personal fulfillment and recreation via the World Health Organization Quality of Life- BREF [WHOQOL-BREF] | Measures Quality of Life defined as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. | Baseline, immediately after intervention, 1 month follow-up | |
Secondary | Drug use or harm reduction practices at the end of the study via semi-structured interviews | Semi-structured interview with member of research team | 1 month follow up | |
Secondary | Barriers to engaging in the intervention using qualitative assessments at the end of study | Semi-structured interview with member of research team | 1 month follow up | |
Secondary | Engagement in treatment | The Treatment Engagement Rating Scale was developed to assess patient engagement and behaviour change after an 8 week intervention; and will be adapted for this population. It is filled out by the study clinician for each participant. | Immediately after intervention |
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