CONNECT for Depressed Cannabis Users Trial

NCT03727659 | Completed DMC

• 1 other identifier: CONNECT
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the usefulness of a computer-assisted intervention for depressed cannabis users by combining peer and therapist social network support via Facebook that uses the techniques of cognitive behavioral therapy and motivational enhancement therapy (CBT/MET) to help with relapse prevention skills, reduce cannabis use and depressive symptoms, and improve treatment adherence. All participants will receive 10 weeks of the computer assisted intervention which includes weekly 60 minute (1 hour) sessions. All participants will also be part of a secret Facebook group (CONNECT). The goal of this secret Facebook group is to reinforce the knowledge and skills taught in the computer assisted intervention and to provide social support.

Conditions

Substance Abuse; Depression

Keywords

Cannabis; CONNECT; Depression; FaceBook

Outcome Measures

Primary Outcomes (3)

• Change in illicit drug use between study visits and at follow up

  Substance use will be tracked with urine drug screens between each study visit.

  Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14).

• Change in depression symptoms and severity between study visits and at follow up

  Depression will be tracked with a questionnaire designed to capture frequency and severity of depression symptoms; Patient Health Questionnaire-9 (PHQ9) at each study visit. The scale of the PHQ-9 is 0-27 where 0-4=Minimal or none; 5-9=Mild; 10-14=Moderate; 15-19=Moderately severe; 20-27=Severe.

  Baseline (week 0), weekly during treatment (weeks 1-10) and follow up (week 14)

• Change in adherence to collateral psychiatric treatment between study visits and at follow up

  Treatment adherence to collateral therapy and medication will be tracked with self-report questionnaire (Ancillary Treatment Record).

  Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)

Secondary Outcomes (2)

• Change in alcohol use between study visits and at follow up

  Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)

• Change in alcohol, tobacco and other drug use between study visits and at follow up

  Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)

Study Arms (1)

SHADE therapy + CONNECT FaceBook support

EXPERIMENTAL

SHADE is a 10-week, 10-session, computerized CBT/MET intervention for Cannabis Use Disorder and depression. At each visit, a study clinician meets with participants for a 'check-in' session, which includes: review of homework; plans for completing homework; suicide risk and mood assessment. The CONNECT FB intervention component will facilitate social support for between-session homework and CBT skills practice for managing depression and preventing relapse, and bolstering motivation to change. Daily posts will be delivered. Only those participating in the study will know about the existence of this group and will be able to access it. A weekly real-time, Facebook chat session will be held to provide feedback concerning homework practice or answer questions.

Behavioral: SHADE therapy + CONNECT FaceBook support

Interventions

SHADE therapy + CONNECT FaceBook support BEHAVIORAL

See "study arms" description.

SHADE therapy + CONNECT FaceBook support

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 65;
• DSM-5 diagnosis of CUD, with use reported on \>50 of the past 90 days;
• DSM-5 diagnosis of Major Depressive Disorder (Lifetime);
• Current Patient Health Questionnaire-9 (PHQ9) score \> 9;
• Uses Facebook or willing to join and learn how to use it;
• Having received treatment for depression in the past year.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Integrated Substance Abuse Programs

Los Angeles, California, 90025, United States

Location

Related Publications (3)

• Glasner-Edwards S, Rawson R. Evidence-based practices in addiction treatment: review and recommendations for public policy. Health Policy. 2010 Oct;97(2-3):93-104. doi: 10.1016/j.healthpol.2010.05.013. Epub 2010 Jun 16.

  PMID: 20557970 BACKGROUND

• Aspis I, Feingold D, Weiser M, Rehm J, Shoval G, Lev-Ran S. Cannabis use and mental health-related quality of life among individuals with depressive disorders. Psychiatry Res. 2015 Dec 15;230(2):341-9. doi: 10.1016/j.psychres.2015.09.014. Epub 2015 Sep 10.

  PMID: 26388103 BACKGROUND

• Cornelius JB, Cato MG, Toth JL, Bard PM, Moore MW, White A. Following the trail of an HIV-prevention Web site enhanced for mobile cell phone text messaging delivery. J Assoc Nurses AIDS Care. 2012 May-Jun;23(3):255-9. doi: 10.1016/j.jana.2011.03.002. Epub 2011 May 7. No abstract available.

  PMID: 21550826 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Marijuana Abuse

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Suzette Glasner, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

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: Research Psychologist

Model Details: Participants will receive SHADE therapy for drug use and depression for 10 weeks plus CONNECT FaceBook social support.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 1, 2018
• Study Start: March 22, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)