Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability - Screening
研究概览
简要总结
This is a pilot study of acceptability, feasibility, and preliminary efficacy of a brief, 10-session Behavioral Activation intervention delivered via teletherapy to increase physical activity and treat depressive symptoms.
详细描述
This is a one-site, two-phase study that will use an initial group of individuals between the ages of 18 and 64 who have moderate to severe depressive symptoms and exercise less than 90 minutes a week. In both phases, participants will complete a total of 8 behavioral activation teletherapy sessions used to increase physical activity, followed by two biweekly booster sessions, for a total of 10 sessions. Participants will also complete weekly assessments remotely for both phases of the study. The screening visit and final intervention session will be in-person, and all other visits will be via telehealth. Participants will have the option to come to the clinic if they prefer.
In the initial phase (n = 15), participants who completed the intervention will have the option to participate in a focus group, and participants who partially completed the intervention will have the option to participate in a semi-structured interview. The total duration of phase one is 14 weeks. This initial phase will allow the researchers to refine and optimize the intervention to be delivered in the second phase.
In the second/pilot phase (n = 50), participants will complete a one-month and a two-month follow-up after the 10 intervention sessions. The total duration for phase two is 22 weeks.
Participants for both phases of the study will wear a Fitbit during the duration of their study participation, in order to record step count.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be18-64 years old;
- •Able and willing to provide informed consent;
- •Have moderate-to-severe depressive symptoms, with a PHQ-9 score ≥ 10;
- •Insufficient moderate-to-vigorous physical activity (< 90 minutes a week);
- •Demonstrated interest in increasing physical activity;
- •Have a smartphone.
排除标准
- •Have any current, past, or lifetime manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder;
- •Be currently experiencing active suicidal ideation (i.e. with suicidal thoughts, plan, and intent) or at a high risk for suicide during the course of the study, as designated by the PI;
- •Have a medical condition that prohibits physical activity; be medically prohibited to exercise by primary care physician (PCP), OB-GYN (obstetrician-gynecologist) or study MD.
- •Be in current, active psychotherapy
结局指标
主要结局
Feasibility and acceptability - Screening
时间窗: 1 week
Number of participants screened per week (Goal 1-2 per week)
Intervention Adherence
时间窗: Up to 14 weeks
Percentage of intervention sessions attended (goal 75%)
Participant retention
时间窗: Up to 22 weeks
Percentage of PHQ-9 assessments completed (Goal: 80%)
Participant outcome completion
时间窗: Up to 22 weeks
Percentage of valid Fitbit wear days \> 12 hours (Goal: 80%)
Feasibility and acceptability - Recruitment
时间窗: 1 week
Percentage of screened participants enrolled (Goal: 50%)
Intervention Validity via Quality of Behavioral Activation Short Form
时间窗: Up to 14 weeks
Fidelity on supervisor's structured feedback form with average item score ≥3. The 14-item scale has each item ranging from 0-6, with higher values indicating higher levels of fidelity.
次要结局
- Physical activity - self-report days per week(Up to 22 weeks)
- Physical activity - Fitbit step counter active minutes(Up to 22 weeks)
- Physical activity - self-report minutes per day(Up to 22 weeks)
- Physical activity - Fitbit step counter step count(Up to 22 weeks)
- Depressive symptoms - 9-item Patient Health Questionnaire(Up to 22 weeks)
研究者
Madhukar H. Trivedi, MD
Professor of Medicine
University of Texas Southwestern Medical Center