Substance AbuseCONNECTNCT03727659
CONNECT for Depressed Cannabis Users Trial
A study testing SHADE therapy + CONNECT FaceBook support in people with Substance Abuse and Depression, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse, Depression
- What is being tested?
- SHADE therapy + CONNECT FaceBook support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Abuse, Depression
- Being tested
- SHADE therapy + CONNECT FaceBook support
- Keywords
- Cannabis, CONNECT, Depression, FaceBook
- Medical subject headings
- Substance-Related Disorders, Depression, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHADE therapy + CONNECT FaceBook supportBehavioural
See "study arms" description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SHADE therapy + CONNECT FaceBook support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Breathalyzer test will be used at each study visit to obtain blood alcohol level.
Measured: 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
Alcohol tobacco and other drug use will be obtained through verbal history using the Timeline follow back (TLFB) interview at each study visit.
Measured: Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start22 Mar 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive SHADE therapy for drug use and depression for 10 weeks plus CONNECT FaceBook social support.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzette Glasner-Edwards, University of California, Los Angeles
- Investigators
- Suzette Glasner, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727659
- Sponsor's protocol ID
- CONNECT
- Acronym
- CONNECT
- Status last verified
- Feb 2021
- First submitted
- 17 Oct 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Publications
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.
PubMed 20557970Aspis 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.
PubMed 26388103Cornelius 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.
PubMed 21550826
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONNECT: A Social Media Intervention for Depressed Cannabis Users
- ClinicalTrials.gov ID
- NCT03727659
- Acronym / sponsor ID
- CONNECT / CONNECT
- Conditions
- Substance Abuse, Depression
- Keywords
- Cannabis, CONNECT, Depression, FaceBook
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive SHADE therapy for drug use and depression for 10 weeks plus CONNECT FaceBook social support.
| Arm | Type | Receives |
|---|---|---|
| SHADE therapy + CONNECT FaceBook support | Experimental | Behavioral: SHADE therapy + CONNECT FaceBook supportSHADE 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHADE therapy + CONNECT FaceBook supportSee "study arms" description. | Behavioural | SHADE therapy + CONNECT FaceBook support |
Primary outcome
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).
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 20557970Glasner-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.
- Background: PubMed 26388103Aspis 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.
- Background: PubMed 21550826Cornelius 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
Related trials for Substance Abuse
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
RecruitingObservational study
Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
Voiding Dysfunction, Substance Abuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzette Glasner, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHADE therapy + CONNECT FaceBook support in people with Substance Abuse and Depression, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.