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临床试验/NCT03727659
NCT03727659已完成不适用

CONNECT: A Social Media Intervention for Depressed Cannabis Users

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Change in depression symptoms and severity between study visits and at follow up

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Change in depression symptoms and severity between study visits and at follow up

时间窗: 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

时间窗: 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 illicit drug use between study visits and at follow up

时间窗: 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.

次要结局

  • Change in alcohol use between study visits and at follow up(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(Baseline (week 0), weekly during treatment (weeks 1-10), and follow up (week 14))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzette Glasner-Edwards

Research Psychologist

University of California, Los Angeles

研究点 (2)

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