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
|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse Depression||Behavioral: SHADE therapy + CONNECT FaceBook support||Not Applicable|
Show Detailed Description
|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)|
|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|
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.
- 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.
- 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.
- 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).
- 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.
- 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.
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
|United States, California|
|UCLA Integrated Substance Abuse Programs|
|Los Angeles, California, United States, 90025|
|Principal Investigator:||Suzette Glasner, PhD||University of California, Los Angeles|