- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387965
A Brief Cannabis Use Psychoeducation Intervention for Eating Disorder Patients
A Brief Psychoeducation Intervention to Address Cannabis Use Amongst Patients Seeking Eating Disorder Treatment: A Single Blind Randomized Control Trial
The goal of this clinical trial is to learn if providing eating disorder patients with education about the consequences of cannabis (marijuana) use on mental health, gastrointestinal symptoms, eating disorder symptoms, and eating disorder treatment effectiveness increases their knowledge about the cannabis use consequences, intention to reduce cannabis use, and motivation to seek treatment for their cannabis use. The main questions this study aims to answer are:
- Does education about consequences of cannabis use increase eating disorder patients' knowledge about the risks of cannabis use?
- Does education about the consequences of cannabis use increase intention to reduce cannabis use and seek cannabis use treatment among those with eating disorders?
- Does cannabis use interfere with how successful eating disorder treatment is for eating disorder patients?
All participants will receive 20 weeks of eating disorder treatment. In week 1 of treatment, participants will either be assigned to receive education about cannabis use consequences, or be assigned to a control condition where they receive education about consequences of poor sleep. Participants will be asked to complete a number of questionnaires that measure knowledge about cannabis use consequences, intention to reduce use and seek cannabis use treatment, eating disorder symptoms, and cannabis use habits. Researchers will assess how effective providing education about cannabis use consequences is on changing knowledge about cannabis use risks, intention to reduce use, and intention to seek cannabis use treatment. It will also be examined if effectiveness of eating disorder treatment is related to cannabis use habits.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah McComb, Ph.D., C. Psych
- Phone Number: 34263 905-522-1155
- Email: smccomb@stjoes.ca
Study Contact Backup
- Name: Keisha Gobin, Ph.D., C. Psych
- Phone Number: 34093 905.522.1155
- Email: kgobin@stjoes.ca
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8N 3K7
- St. Joseph's Healthcare Hamilton, West 5th Campus
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Contact:
- Sarah McComb, Ph.D., C.Psych
- Phone Number: 34263 905-522-1155
- Email: smccomb@stjoes.ca
-
Contact:
- Keisha Gobin, Ph.D., C. Psych
- Phone Number: 34093 905-522-1155
- Email: kgobin@stjoes.ca
-
Principal Investigator:
- Sarah McComb, Ph.D., C. Psych
-
Sub-Investigator:
- Keisha Gobin, Ph.D., C. Psych
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A patient of St. Joseph's Healthcare Hamilton Eating Disorder Program (i.e. is currently seeking eating disorders treatment)
- Participant has been diagnosed with an eating disorder
- Aged 16+
- Understands written and spoken English
Exclusion Criteria:
- Has not been diagnosed with an eating disorder
- Under the age of 17
- Does not understand written and spoken English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cannabis psychoeducation intervention
Brief psychoeducation will be provided to eating disorder patients seeking treatment regarding the impact of cannabis use on comorbid mental health conditions, sleep, gastrointestinal symptoms, eating disorder symptoms, and eating disorder treatment outcomes.
|
This intervention will provide psychoeducation to eating disorder patients about the risks of using cannabis on mood, anxiety, sleep, substance use, gastrointestinal symptoms, eating disorder symptoms, and eating disorder treatment outcomes.
|
|
Placebo Comparator: Psychoeducation control condition
Brief psychoeducation will be provided to eating disorder patients seeking treatment regarding the impact of poor sleep on mental health outcomes and appropriate sleep hygiene habits.
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Eating disorder patients in the control condition will receive psychoeducation about impacts of poor sleep on mental health and eating disorder treatment outcomes, and strategies to improve sleep hygiene.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of cannabis use consequences
Time Frame: Will be measured at baseline (i.e. 5 minutes into Session 1 of treatment for eating disorders before cannabis psychoeducation is administered), and again at 140 minutes into Session 1 of treatment for eating disorders.
|
Self-perceived knowledge about consequences of cannabis use will be measured using a 100 point visual analogue scale.
Higher scores will indicate greater self-perceived knowledge about the consequences of cannabis use.
|
Will be measured at baseline (i.e. 5 minutes into Session 1 of treatment for eating disorders before cannabis psychoeducation is administered), and again at 140 minutes into Session 1 of treatment for eating disorders.
|
|
Intention to reduce cannabis use
Time Frame: Will be measured at baseline (i.e. 5 minutes into Session 1 of treatment for eating disorders before cannabis psychoeducation is administered), and again at 140 minutes into Session 1 of treatment for eating disorders.
|
Intention to reduce personal cannabis use will be measured using a 100 point visual analogue scale.
Higher scores indicate greater intention to reduce cannabis use.
|
Will be measured at baseline (i.e. 5 minutes into Session 1 of treatment for eating disorders before cannabis psychoeducation is administered), and again at 140 minutes into Session 1 of treatment for eating disorders.
|
|
Intention to seek cannabis use treatment
Time Frame: Will be measured at baseline (i.e. 5 minutes into Session 1 of treatment for eating disorders before cannabis psychoeducation is administered), and again at 140 minutes into Session 1 of treatment for eating disorders.
|
Intention to seek cannabis use treatment will be measured using a 100 point visual analogue scale.
Higher scores indicate greater intention to seek cannabis use treatment.
|
Will be measured at baseline (i.e. 5 minutes into Session 1 of treatment for eating disorders before cannabis psychoeducation is administered), and again at 140 minutes into Session 1 of treatment for eating disorders.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivations for cannabis use
Time Frame: Measured at baseline (i.e. Week 1 of CBT for eating disorders) and through treatment completion (i.e. Week 20 of CBT for eating disorders).
|
Motivations for cannabis use will be measured using the Marijuana Motives Questionnaire (5 subscales measuring motivations regarding enhancement, coping, conformity, expansion, and social). Responses range from 1 to 5, with higher scores indicating greater endorsement of that motivation. Subscale scores are calculated by taking the average score of subscale items. Motivations for cannabis use will also be measured using the Comprehensive Cannabis Motivates Questionnaire (8 subscales measuring motivations regarding food, medicinal, sleep, social, to get high, coping, conformity, creativity). Responses range from 1-5, with higher scores indicating greater endorsement of that motivation. Subscale scores are calculated by taking the average score of subscale items. |
Measured at baseline (i.e. Week 1 of CBT for eating disorders) and through treatment completion (i.e. Week 20 of CBT for eating disorders).
|
|
Cannabis use frequency
Time Frame: Weekly use will be monitored for 20 weeks using a Likert-type question. The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory will be measured twice during Week 1 and Week 20 of CBT for eating disorders
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Will be measured weekly for 20 weeks using a Likert-type question and at Week 1 and Week 20 of CBT for eating disorders using the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory.
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Weekly use will be monitored for 20 weeks using a Likert-type question. The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory will be measured twice during Week 1 and Week 20 of CBT for eating disorders
|
|
Eating disorder symptoms
Time Frame: Administered at Week 1 (baseline) and Week 20 of CBT for eating disorders.
|
Measured using the Eating Disorder Examination Questionnaire, which assesses for symptoms such as restrictive eating, binge eating, purging, exercise, and body image.
This measure has 4 subscale scores (restraint, concern about eating, weight concerns, and shape concerns) and one global score.
Items are answered on a scale of 0 to 6, with higher scores indicating greater eating disorder symptoms.
Subscale scores are calculated by taking the average of subscale item scores.
The global score is calculated by averaging the sum of the 4 subscale scores.
|
Administered at Week 1 (baseline) and Week 20 of CBT for eating disorders.
|
|
Impairment caused by eating disorder
Time Frame: Administered at Week 1 and Week 20 of CBT for eating disorders.
|
Measured using the Clinical Impairment Assessment.
Assesses for impairment caused by eating disorder symptoms, such as negative emotions, concentration difficulties, social impairment.
Items are responded to on a scale of 0 to 3, with higher scores indicating greater impairment on that item.
A total score is calculated by summing all item scores.
|
Administered at Week 1 and Week 20 of CBT for eating disorders.
|
|
Problematic cannabis use
Time Frame: Administered at Week 1 and Week 20 of CBT for eating disorders.
|
Measured using Cannabis Use Disorder Identification Test-Revised.
Assesses for indicators of problematic cannabis use, such as inability to reduce use, using in risky circumstances, increased impairment, and frequency of use.
Items are answered on a scale of 0 to 4, with higher scores indicating more problematic use.
A total score is calculated by summing item scores.
|
Administered at Week 1 and Week 20 of CBT for eating disorders.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah McComb, Ph.D., C. Psych, St. Joseph's Healthcare Hamilton
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18846
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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