Exercise, Mood and Stress Study (NCT02887027) | Clinical Trial Compass
CompletedPhase 1
Exercise, Mood and Stress Study
4 participantsStarted 2016-02
Plain-language summary
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 Preliminary unpublished findings indicate that the app was acceptable and promoted increased physical activity.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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults ages 18 to 65.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Credibility-Expectations Questionnaire (CEQ)
Timeframe: Day 29
2
Client Satisfaction Questionnaire (CSQ-8)
Timeframe: Day 29
3
7-Day Physical Activity Recall (PAR)
Timeframe: 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
4
Physical Activity measured in METS (assessed via Actigraphy)
Timeframe: 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
. 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)
Exclusion criteria
. 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.