CONNECT for Depressed Cannabis Users Trial (CONNECT)

February 8, 2021 updated by: Suzette Glasner-Edwards, University of California, Los Angeles

CONNECT: A Social Media Intervention for Depressed Cannabis Users

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An estimated 8.4 million adults in the U.S. experience co-occurring psychiatric and SUDs, largely accounted for by comorbid mood disorder-SUD. Cannabis is the most widely used illicit substance among individuals with depressive disorders1. Likewise, elevated rates of major depression are observed among those with cannabis use disorders (CUD)2.

The use of technology-based platforms for behavioral intervention delivery in primary care settings, focusing on comorbidity, is a promising approach to broadening availability of evidence-based treatments for this high-need population, at low cost.

With support from a NIDA High Priority, Short-Term Project Award, the present investigative team (PI Dr. Glasner-Edwards and Drs. Budney and Kay-Lambkin) piloted SHADE (Self-Help for Alcohol and Other Drug Use and Depression), a computerized intervention model combining cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET), in a primary psychiatric care setting, where integrated interventions addressing both mental health and SUDs are not readily accessible. Preliminary data indicate that SHADE: (1) was feasible and acceptable, (2) facilitated treatment engagement and retention in a difficult-to-treat comorbid population with major depression and CUD; and (3) effectively reduced cannabis use and depression. As a next step to optimize the efficacy of this intervention model, the present proposal is designed to develop and integrate a social media component to the SHADE intervention program, based on a program established and tested by Co-I Dr. Ramo in an RCT4.

To this end, we propose to: (a) develop and refine, with user feedback, a social media-assisted therapy intervention, CONNECT (Connected Cannabis Users' Network for Enhancement of Cognitive Therapy), which combines the use of Facebook for social network support with SHADE in a population of adults with CUD and major depression; and (b) collect preliminary data to evaluate effect sizes and investigate trends for the impact of CONNECT plus SHADE on cannabis use, depressive symptoms, and health service utilization. Moreover, we will gather preliminary data for social network analysis, to understand the mechanism(s) by which the social media component of CONNECT promotes health behavior change in the key outcome domains of the present study.

The use of a social media platform (i.e., Facebook) will increase the accessibility of the intervention as Facebook can be accessed using a variety of technology devices.

Aim 1. To develop and refine, with user feedback, a 10-week, social media-assisted intervention (CONNECT) combining a computer-assisted, integrated treatment program (SHADE) with private Facebook groups to facilitate peer and clinician support for therapeutic objectives. The CONNECT intervention targets cannabis use and depression in a population of depressed adults with CUD receiving psychiatric care.

Hypothesis 1: Participants will report that CONNECT is user-friendly and helpful in providing opportunities for between-session practice of therapy skills, peer and clinician support, and information that enable them to prevent cannabis relapse and manage depression.

Aim 2. To test the impact of CONNECT plus SHADE on cannabis use, depression, adherence to psychiatric care, and healthcare outcomes.

Hypothesis 2a: Among depressed substance dependent adults in an outpatient psychiatric care setting, CONNECT plus SHADE will led to clinical outcomes in reducing cannabis use and depression, and improving adherence to psychiatric care during and after treatment.

Aim 3. To test whether social network variables mediate or moderate the impact of CONNECT.

Hypothesis 3: Participants with more expansive Facebook social networks within CONNECT will benefit more from the program. Factors that influence engagement in the Facebook component of CONNECT will also be explored (e.g., social network characteristics and content of peer and therapist interaction via the social network), and engagement will be examined as a potential moderator of cannabis use and depression outcomes.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • UCLA Integrated Substance Abuse Programs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHADE therapy + CONNECT FaceBook support
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
See "study arms" description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in illicit drug use between study visits and at follow up
Time Frame: Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14).
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
Time Frame: Baseline (week 0), weekly during treatment (weeks 1-10) and follow up (week 14)
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
Time Frame: Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alcohol use between study visits and at follow up
Time Frame: Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)
Breathalyzer test will be used at each study visit to obtain blood alcohol level.
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
Time Frame: Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)
Alcohol tobacco and other drug use will be obtained through verbal history using the Timeline follow back (TLFB) interview at each study visit.
Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Suzette Glasner, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONNECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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