Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 887
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-8
研究概览
简要总结
Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.
The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.
The secondary aims of this study are to:
- calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.
- calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.
- calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.
- determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.
Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. Participants will be aware that there are other arms of the study to which other participants are randomized, but they will not be aware of what these other arms entail. Additionally, the measures will be self-administered, so there is no scope for evaluator bias.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Located in the United States
- •Baseline Patient Health Questionnaire-8 (PHQ-8) score >= 10
- •Able to read and write English
- •Able to access to the internet via a computer, tablet or smartphone for the next eight weeks
排除标准
- •Participants who have participated in another related study on depression from our laboratory via the same participant recruitment platform in the past two months
- •Participants who have submitted gibberish in open response questions
研究组 & 干预措施
Arm 1
Experimental: Breathing exercise + active elements 1, 2, 3
In this arm, all three factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
- Action planning
干预措施: Psychoeducation (Behavioral)
Arm 1
Experimental: Breathing exercise + active elements 1, 2, 3
In this arm, all three factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
- Action planning
干预措施: Testimonials and Saying is believing exercises (Behavioral)
Arm 1
Experimental: Breathing exercise + active elements 1, 2, 3
In this arm, all three factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
- Action planning
干预措施: Action planning (Behavioral)
Arm 1
Experimental: Breathing exercise + active elements 1, 2, 3
In this arm, all three factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
- Action planning
干预措施: Breathing exercise (Behavioral)
Arm 2
Experimental: Breathing exercise + active elements 1, 2
In this arm, two factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
干预措施: Psychoeducation (Behavioral)
Arm 2
Experimental: Breathing exercise + active elements 1, 2
In this arm, two factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
干预措施: Testimonials and Saying is believing exercises (Behavioral)
Arm 2
Experimental: Breathing exercise + active elements 1, 2
In this arm, two factors are set to active (i.e. yes):
- Psychoeducation
- Testimonials and Saying is believing exercises
干预措施: Breathing exercise (Behavioral)
Arm 3
Experimental: Breathing exercise + active elements 1, 3
In this arm, two factors are set to active (i.e. yes):
- Psychoeducation
- Action planning
干预措施: Psychoeducation (Behavioral)
Arm 3
Experimental: Breathing exercise + active elements 1, 3
In this arm, two factors are set to active (i.e. yes):
- Psychoeducation
- Action planning
干预措施: Action planning (Behavioral)
Arm 3
Experimental: Breathing exercise + active elements 1, 3
In this arm, two factors are set to active (i.e. yes):
- Psychoeducation
- Action planning
干预措施: Breathing exercise (Behavioral)
Arm 4
Experimental: Breathing exercise + active elements 2, 3
In this arm, two factors are set to active (i.e. yes):
- Testimonials and Saying is believing exercises
- Action planning
干预措施: Testimonials and Saying is believing exercises (Behavioral)
Arm 4
Experimental: Breathing exercise + active elements 2, 3
In this arm, two factors are set to active (i.e. yes):
- Testimonials and Saying is believing exercises
- Action planning
干预措施: Breathing exercise (Behavioral)
Arm 5
Experimental: Breathing exercise + active element 1
In this arm, one factor is set to active (i.e. yes):
• Psychoeducation
干预措施: Psychoeducation (Behavioral)
Arm 5
Experimental: Breathing exercise + active element 1
In this arm, one factor is set to active (i.e. yes):
• Psychoeducation
干预措施: Breathing exercise (Behavioral)
Arm 6
Experimental: Breathing exercise + active element 2
In this arm, one factor is set to active (i.e. yes):
• Testimonials and Saying is believing exercises
干预措施: Testimonials and Saying is believing exercises (Behavioral)
Arm 6
Experimental: Breathing exercise + active element 2
In this arm, one factor is set to active (i.e. yes):
• Testimonials and Saying is believing exercises
干预措施: Breathing exercise (Behavioral)
Arm 7
Experimental: Breathing exercise + active element 3
In this arm, one factor is set to active (i.e. yes):
• Action planning
干预措施: Action planning (Behavioral)
Arm 7
Experimental: Breathing exercise + active element 3
In this arm, one factor is set to active (i.e. yes):
• Action planning
干预措施: Breathing exercise (Behavioral)
Arm 8
Experimental: Breathing exercise only
In this arm, none of the three factors are set to active (i.e. yes)
干预措施: Breathing exercise (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-8
时间窗: Baseline to 8-week post-intervention
Patient Health Questionnaire-8 is a well-validated and self-administered measure to assess depression symptom severity in the general population. Participants are asked to rate how often they are bothered by 8 items (e.g., Poor appetite or overeating) on a scale of 0 (Not at all) to 3 (Nearly every day). Total score can range from 0 to 24, with higher scores indicating higher symptom severity.
次要结局
- Balanced measure of Psychological Needs scale(Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention)
- Beck Hopelessness Scale-4(Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention)
- Patient Health Questionnaire-8(Baseline to 2-week post-intervention)
研究者
Jessica Schleider
Associate Professor, Northwestern University
Northwestern University