Evaluation of an ACT-based Narrative Intervention for Individuals Taking Antidepressant Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in depression severity
研究概览
简要总结
This study aims to compare the efficacy of LifeStories on depression symptomatology compared to antidepressant treatment alone, in addition to examining the effect of the intervention on health-related quality of life. Participants will be randomly assigned to either an online ACT-based narrative intervention (Lifestories) or the waitlist control condition (antidepressant treatment alone). It is hypothesized that participants who receive the LifeStories will result in decreased depression and increased quality of life, general functioning and decreased psychological inflexibility compared to the waitlist group.
详细描述
The purpose of this study is to test the efficacy of an online, self-guided ACT-based narrative intervention for adults currently taking antidepressant medication. To test the effects of LifeStories on depression severity, quality of life, general functioning and psychological inflexibility, the investigators will conduct a randomized controlled trial with two conditions (LifeStories and waitlist control) using a sample of 90 adults currently taking antidepressant medication. Interested individuals will complete a screening survey to determine eligibility. After being informed about the study and potential risks, eligible participants who provide informed consent will be asked to complete a baseline survey. Participants will then be randomized to LifeStories or a waitlist control conditions, each lasting 4 weeks. Those in the waitlist group will be asked to not use other self-help websites or books for four weeks, after which they will be given weekly access to LifeStories modules. Participants in both groups will be asked to complete a midtreatment survey 2 weeks after baseline, and a posttreatment survey 4 weeks after baseline (i.e. after completing the 4-week video intervention for those in the active condition).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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 of age or older
- •Currently residing in the United States
- •Currently taking antidepressant medication prescribed by a primary care provider (PCP)
- •Meets criteria for at least moderate depression on the 9-item Patient Health Questionnaire
- •Fluent in English
- •Reliable access to an internet browser, and internet speed that is sufficient for streaming online videos
排除标准
- •Change in medication regimen in past 6 weeks
- •Presently seeing a mental health specialist (e.g. psychologist, psychiatrist, counselor, social worker)
研究组 & 干预措施
Lifestories
Participants in this condition will be actively participating in the online intervention for 4 weeks.
干预措施: LifeStories (Behavioral)
Waitlist Control Condition
Participant in the waitlist group will be asked to not use other self-help websites or books for four weeks, after which they will be given weekly access to LifeStories modules. All participants will be asked to continue their antidepressant treatment as usual as directed by their primary care provider.
结局指标
主要结局
Change in depression severity
时间窗: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)
Patient Health Questionnaire 9-item (PHQ-9; Kroenke et al., 2001): The PHQ is a 9-item measure of depression severity, which asks respondents to report their frequency of depressive symptoms over the past two weeks, rated from 0 "not at all" to 3 "nearly every day". The PHQ-9 provides a total score which indicates current depression severity according to the following levels: minimal, mild, moderate, moderately severe, and severe. Higher scores indicate higher depression.
次要结局
- Change in psychological inflexibility(Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline))
- Change in health-related quality of life(Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline))
研究者
Michael Levin
Associate Professor
Utah State University