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CONNECT for Depressed Cannabis Users Trial (CONNECT)

Primary Purpose

Substance Abuse, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHADE therapy + CONNECT FaceBook support
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Cannabis, CONNECT, Depression, FaceBook

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • UCLA Integrated Substance Abuse Programs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHADE therapy + CONNECT FaceBook support

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Change in alcohol use between study visits and at follow up
Breathalyzer test will be used at each study visit to obtain blood alcohol level.
Change in alcohol, tobacco and other drug use between study visits and at follow up
Alcohol tobacco and other drug use will be obtained through verbal history using the Timeline follow back (TLFB) interview at each study visit.

Full Information

First Posted
October 17, 2018
Last Updated
February 8, 2021
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03727659
Brief Title
CONNECT for Depressed Cannabis Users Trial
Acronym
CONNECT
Official Title
CONNECT: A Social Media Intervention for Depressed Cannabis Users
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Depression
Keywords
Cannabis, CONNECT, Depression, FaceBook

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will receive SHADE therapy for drug use and depression for 10 weeks plus CONNECT FaceBook social support.
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHADE therapy + CONNECT FaceBook support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SHADE therapy + CONNECT FaceBook support
Intervention Description
See "study arms" description.
Primary Outcome Measure Information:
Title
Change in illicit drug use between study visits and at follow up
Description
Substance use will be tracked with urine drug screens between each study visit.
Time Frame
Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14).
Title
Change in depression symptoms and severity between study visits and at follow up
Description
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.
Time Frame
Baseline (week 0), weekly during treatment (weeks 1-10) and follow up (week 14)
Title
Change in adherence to collateral psychiatric treatment between study visits and at follow up
Description
Treatment adherence to collateral therapy and medication will be tracked with self-report questionnaire (Ancillary Treatment Record).
Time Frame
Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)
Secondary Outcome Measure Information:
Title
Change in alcohol use between study visits and at follow up
Description
Breathalyzer test will be used at each study visit to obtain blood alcohol level.
Time Frame
Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)
Title
Change in alcohol, tobacco and other drug use between study visits and at follow up
Description
Alcohol tobacco and other drug use will be obtained through verbal history using the Timeline follow back (TLFB) interview at each study visit.
Time Frame
Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzette Glasner, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Programs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers.
Citations:
PubMed Identifier
20557970
Citation
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.
Results Reference
background
PubMed Identifier
26388103
Citation
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.
Results Reference
background
PubMed Identifier
21550826
Citation
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.
Results Reference
background

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CONNECT for Depressed Cannabis Users Trial

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