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CONNECT for Depressed Cannabis Users Trial (CONNECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03727659
Recruitment Status : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Suzette Glasner-Edwards, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Depression Behavioral: SHADE therapy + CONNECT FaceBook support Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will receive SHADE therapy for drug use and depression for 10 weeks plus CONNECT FaceBook social support.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CONNECT: A Social Media Intervention for Depressed Cannabis Users
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727659


Locations
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United States, California
UCLA Integrated Substance Abuse Programs
Los Angeles, California, United States, 90025
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Suzette Glasner, PhD University of California, Los Angeles

Publications:
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Responsible Party: Suzette Glasner-Edwards, Research Psychologist, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03727659     History of Changes
Other Study ID Numbers: CONNECT
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suzette Glasner-Edwards, University of California, Los Angeles:
Cannabis
CONNECT
Depression
FaceBook

Additional relevant MeSH terms:
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Depression
Marijuana Abuse
Substance-Related Disorders
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders