Variable-dose Support in an Online Mental Health Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Weekly Change in Willingness to Refer
研究概览
简要总结
This is a pilot study of an online mental health treatment. The goals of the study are to determine the feasibility of an online treatment for depression and anxiety symptoms with little-to-no human support, in a sample of 50 adults with limited educational attainment. The treatment is based on the Unified Protocol, an evidence-based treatment for mood and anxiety symptoms. The study will enroll participants on a rolling basis until reaching the goal of 50 participants. The intervention lasts 16 weeks, with 12 weeks of online treatment focused on increasing mindfulness, decreasing avoidance, and increasing cognitive flexibility in order to decrease depression and anxiety symptoms. Participants will complete surveys about their symptoms and how they feel about the treatment to help us establish the feasibility of a larger trial.
详细描述
The study is a 12-week, randomized controlled trial ("Hazel") comparing an intervention for depression and anxiety symptoms with two different levels of support. Eligible participants will be randomized to receive: 1) a Unified Protocol intervention with 4 weeks of human support during exposure exercises in weeks 8-11 ("Partially Supported"); or 2) a Unified Protocol intervention without support at any point (the "Unsupported" arm). At 4 weeks post-intervention, participants will be sent a link to complete follow-up survey measures for depression and anxiety symptoms.
The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy.27 The Unified Protocol can be delivered in 12 to 18 weeks, with one one-hour session per week. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors while decreasing avoidance of emotions and physiological sensations. Each week, patients receive psychoeducation, complete in-session practice exercises and self-monitor symptom change. At the end of each session, patients are assigned a home practice assignment to increase adaptive coping and generalize skill use outside of the therapy room.
Participants in both arms will receive a 12-week Unified Protocol intervention delivered via the same web platform (REDCap). The intervention will include all 8 modules of the Unified Protocol. Every week, participants will be directed to complete the following content:
- depression symptom survey,
- anxiety symptom survey,
- information about their symptom change over time,
- psychoeducational text
- practice exercises,
- home practice instructions,
- writing exercise, and
- home practice worksheet(s).
The symptom surveys, symptom graph and writing exercise will remain the same each week. The psychoeducational text, practice exercises and homework assignments will vary based on that week's topic. For the writing exercise, participants will be prompted to write notes on their take-aways, questions about the material, and ways they can incorporate the lesson into their upcoming week. The investigators will aim to write as much text as possible at a 5th grade reading level, based on evidence that 52% of US residents read English at a 5th-grade level or below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Neither participants nor study therapists will be blinded to participant condition, as it is not feasible to blind to whether or not someone is receiving therapist support.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old
- •Fluent in reading and writing English
- •Internet/data plan and computer/tablet/phone access for length of study
- •Overall Depression Severity and Impairment Scale (ODSIS) and/or Overall Anxiety Severity and Impairment Scale (OASIS) summary score >= 8
- •Live in North Carolina for the duration of the study
排除标准
- •Educational attainment greater than high school diploma/equivalent
- •Currently receiving other psychotherapy or planning to receive other psychotherapy during course of intervention
- •>=8 sessions of cognitive-behavioral therapy in past 12 months
- •Currently taking psychiatric medications or planning to take psychiatric medications during course of intervention
- •Current suicidality, operationalized as a positive result on the Ask Suicide-Screening Questions (ASQ) Tool
- •Self-harm in past 12 months
- •Current psychosis, as measured by Mini International Neuropsychiatric Interview Subsection K. Psychotic Disorders
- •Substance abuse (other than nicotine, cannabis or caffeine) in the past 12 months, as measured by Structured Clinical Interview for The Diagnostic and Statistical Manual of Mental Disorders-5 substance use disorders subsection (past 12 months only)
- •BMI <= 18.5
结局指标
主要结局
Weekly Change in Willingness to Refer
时间窗: through study completion, an average of 12 weeks
yes/no question if participants would recommend the intervention to others
Change in COPE Inventory - Avoidance Factor Score
时间窗: through study completion, an average of 12 weeks
COPE Inventory is a survey of coping strategies with 60-items split across 15 4-item scales; factor analysis has identified a 16-item avoidance factor, comprising 4 4-item subscales (mental disengagement, denial, behavioral disengagement, and substance use) which will be used for this study as the remaining items on the full COPE Inventory are not related to primary mechanisms of change in this intervention
Change in Cognitive Flexibility Inventory Score
时间窗: through study completion, an average of 12 weeks
20-item measure of cognitive flexibility designed to be used for repeated measures over the course of an intervention
Change in Cognitive and Affective Mindfulness Scale-Revised Score
时间窗: through study completion, an average of 12 weeks
10-item questionnaire that assesses mindfulness of thoughts and emotions
Total Number of Referrals (Sum Score)
时间窗: through study completion, an average of 12 weeks
pts who select yes for willingness to refer will be given option to actually make referrals. this will calculate a sum score of total number of referrals
Change Between Baseline and Post-Treatment System Usability Scale Score
时间窗: through study completion, an average of 12 weeks
10-item, validated self-report user experience survey for digital systems answered on a five-point Likert scale
次要结局
- Change in Overall Depression Severity and Impairment Scale Score(through study completion, an average of 12 weeks)
- Change in Overall Anxiety Severity and Impairment Scale Score(through study completion, an average of 12 weeks)
研究者
Heather Parnell
PhD Candidate
Duke University