Developing an Ecological Momentary Exercise Intervention: Open Trial With Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 主要终点
- Credibility-Expectations Questionnaire (CEQ)
研究概览
简要总结
Multiple studies indicate that exercise is effective in treating depressed mood and reducing anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in individuals with anxiety and depressive disorders, exercise could help reduce these symptoms and aid in the overall treatment of these disorders. This project aims to test an ecological momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in individuals with anxiety or depressive disorders. Previous protocols have tested the acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the study, focus groups were conducted to explore the acceptability and usability of the Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6 healthy participants. Preliminary unpublished findings indicate that the app was acceptable and promoted increased physical activity. The aim of this protocol is to test the acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood in patients with anxiety or depressive disorders.
详细描述
Design: A multiple baseline design will be employed: the intervention will be introduced in the 1st participant after a baseline period of 8 days, in the 2nd participant after 11 days, and in the 3rd participant after 15 days. The same pattern will be followed for participants 4-6. Participants will be in the intervention period for 21 days, 18 days, and 14 days respectively, at a prescription of 150 minutes of moderate intensity
Screening Visit:
Individuals who pass the phone screen will be invited to come to our laboratory for remaining screening procedures. At the screening visit, in-person assessment will include informed consent procedures, evaluation of psychiatric inclusion/exclusion criteria and mood, anxiety and traumatic stress disorders with the Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 Adult Version (ADIS-5) and additional informal assessment if needed (e.g. to assess eating disorders). The diagnostic assessment will be performed by a study staff member who has been trained in administration of the ADIS-5 and clinical interviewing. If a diagnostic assessment has been conducted at the Center for Anxiety and Related Disorders (CARD) at Boston University within the last six weeks, participants will be given the option to provide consent for it to be used instead (plus additional portions of the ADIS-5 if needed). Eligible participants will be assigned to one of the three conditions above (as this is a single case design, it is not randomized; participants are assigned sequentially to the conditions above). The Screening Visit, which will last 1 hour, may take place on the same or a different day as the pre-baseline visit depending on the researcher and participant's availability.
Pre-Baseline Visit (Day 1):
This in-person visit will occur on Day 1 before the baseline recording period and last 45 minutes. Participants will complete baseline questionnaires and a Physical Activity Recall interview (PAR). Participants' height and weight will be collected. Participants will be given a tutorial on and be provided with an activity and heart monitoring device to wear. Participants will be instructed to engage in their normal level of activity until their next visit. They will be instructed to wear an activity monitor during all waking hours and a heart rate monitor if they exercise. They will be scheduled for a Pre-Intervention Visit either 8, 11, or 15 days later (depending on assignment above).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Adults ages 18 to
- •Ability to read and provide informed consent
- •Ownership of an iPhone smartphone device
- •Sedentary as defined as not participating in at least 90 minutes of moderate-intensity exercise per week for at least 3 months.
- •At least minimally active as defined as participating in an average of 10 minutes of mild-intensity physical activity (e.g. walking) per day for the past two weeks.
- •Interest in increasing exercise
- •Daily access to the Internet
- •Current DSM 5 diagnosis of an Anxiety Disorder, Depressive Disorder (i.e. Major Depressive Disorder or Persistent Depressive Disorder), or Post-Traumatic Stress Disorder (PTSD)
- •Sufficient command of the English language
排除标准
- •Participants considered high risk based on the American College Sports Medicine risk stratification guidelines.
- •Participants meeting DSM-5 criteria for a Substance-Related Disorder in the last three months (other than caffeine or nicotine dependence)
- •Participants meeting DSM-5 criteria for past or present Bipolar I or II Disorder or Schizophrenia Spectrum or Other Psychotic Disorder
- •Participants meeting DSM-5 criteria for past or present Eating Disorder
- •Participants endorsing active suicidality, homicidality, or self-destructive acts or urges as assessed through the phone screen and the ADIS
- •Individuals who are not stable (i.e., at the same dosage for at least the past 4 weeks) on psychotropic medications. Current engagement in psychotherapy is permitted.
研究组 & 干预措施
Exercise Group 1
Participants assigned to this group will complete a baseline period of 8 days and an Exercise4Mood Intervention period of 21 days.
干预措施: Exercise4Mood Intervention (Behavioral)
Exercise Group 2
Participants assigned to this group will complete a baseline period of 11 days and an Exercise4Mood Intervention period of 18 days.
干预措施: Exercise4Mood Intervention (Behavioral)
Exercise Group 3
Participants assigned to this group will complete a baseline period of 15 days and an Exercise4Mood Intervention period of 14 days.
干预措施: Exercise4Mood Intervention (Behavioral)
结局指标
主要结局
Credibility-Expectations Questionnaire (CEQ)
时间窗: Day 29
The CEQ is a 6-item self-report questionnaire, which assesses treatment rationale and expectancy. The scale has been used across a number of treatment trials.
Client Satisfaction Questionnaire (CSQ-8)
时间窗: Day 29
The CSQ-8 is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The CSQ-8 is a valid, efficient, and sensitive measure of client satisfaction and has been used across populations and mental health services (Attkisson et al, 1994; Attkisson \& Zwick, 1982).
7-Day Physical Activity Recall (PAR)
时间窗: Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days
The is an interviewer-administered procedure assessment of physical activity. Validity and reliability of this technique have been demonstrated (Blair et al., 1985; Sallis et al., 1998) and it has been used in numerous studies. This instrument has been shown to be sensitive to change in studies of moderate intensity activity (Dunn et al., 1998; Dunn et al., 1999).
Physical Activity measured in METS (assessed via Actigraphy)
时间窗: Change from the start of the baseline period, an expected average of 11 days assessed daily through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days
Participants will be lent an ActiGraph (ActiSleep-BT model) wireless activity monitor and Polar heart rate monitor (Polar FT) to wear during the baseline and intervention period. The actigraph is a compact and lightweight device that is worn on an adjustable elastic strap around the waist in conjunction with the heart rate monitor strap that fits securely around the participant's chest area. Participants will be asked to wear the activity monitor during all waking hours and the heart rate monitor only when they are exercising. They will return these devices at the Endpoint Visit.
次要结局
- Anxiety Sensitivity Index (ASI)(Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days)
- Center for Epidemiological Studies-Depression (CES-D)(Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days)
- PTSD Checklist for DSM 5 (PCL) - for individuals with PTSD diagnosis only(Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days)
- Depression Anxiety Stress Scale 21 (DASS 21)(Change from the start of the baseline period, an expected average of 11 days assessed weekly through the start of the intervention period, which is expected to last an expected average of 19 days for a total of 30 days)
研究者
Maria Alexandra Kredlow Acunzo
Graduate Student
Boston University