A-B-C Program for Sedentary Older Adults With Depressive Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe Royal Ottawa Mental Health Centre
About this trial
The importance and benefits of leading a physically active lifestyle have been long studied. Examples of the multiple advantages from physical activity are improved health of the heart and brain, having a more independent living and better quality of life. However, it is known that for many people, being active is challenging: physical activity is commonly viewed as a burden or inconvenience. In this study we will explore how some common everyday thoughts are hurdles to becoming physically active. We will discover ways to overcome this by using concepts from a field called "behavioral economics" that explains how we make decisions. The purpose of the program is to support participants in being more physically active. The study program is a newly developed way to overcome the intuitive preference for being sedentary. The experimental groups will learn simple ways to overcome expected hurdles in making decisions related to physical activity (the newly developed program), and the control groups will learn about the health benefits of physical activity and the health guidelines (the common practice today). We will compare the effectiveness of the newly developed intervention in promoting an active lifestyle, compared to the common practice today, of providing the knowledge and the recommended guidelines. The program in the study will be in small groups of 5-10 participants that will meet at The Royal for 60 minutes, twice a week, for 4 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. All sex and gender inclusive 2. Age 65 and over 3. Cognitive telephone screening via the 20-point Tele-MoCA with a score of 16 or higher.
Disqualifiers
1. Acute medical condition that requires treatment. 2. Existing medical conditions that contra-indicate or limit physical activity (e.g., post-surgery, recurrent falls, etc.) 3. Unstable psychiatric condition that requires acute care. 4. Current use of psychoactive medication that might compromise balance or induce risk when performing physical activity (e.g., high dose of sedative medications) 5. Current use of recreational drug use (must be free of substance use for 12 months).
Trial design
Design model
Parallel
Treatments tested in this trial
A-B-C Program
BehavioralThe purpose of this study is to assess the effectiveness of the 4-week "A-B-C" program in implementing and maintaining daily PA. We will explore outcomes for the effectiveness of the program, on (1) increasing the weekly duration of PA, and (2) reducing baseline depressive symptoms and other mental health outcomes among sedentary older adults with depressive symptoms at baseline. Specifically, we will evaluate the change in depressive symptoms, stress, and self-esteem from baseline, at the end of the 4-week intervention, and after additional 4 weeks from the end of the intervention (at follow-up). The intervention will be 4 weeks overall, with total of 8 sessions: the duration of each session will be 60 minutes each, and the frequency will be twice weekly for 4 weeks.
Physical Activity Educational Program
Other interventionThe control group will serve as an sham active comparator, designed to control for group format, scheduled sessions, and social interaction. The agenda for the control group was designed to specifically function as a control to compare the A-B-C program. These participants will also attend twice-weekly 60-minute sessions over four weeks, focusing on educational content about the health benefits of physical activity and current physical activity guidelines. The difference between the two interventions is that the control program is strictly educational, whereas the A-B-C program focuses on challenging cognitive biases that change decision making related to physical activity. To reiterate, the control program simply provides education on the effects of physical activity with physiological evidence.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: A-B-C GroupExperimental treatment 1 intervention
Group B: Physical activity educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Daily dose of PA
Daily dose of PA (intensity, duration) - will be self-reported and recorded participants in their daily program journals.
Time frame
From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.Secondary outcomes
1
Patient Health Questionnaire 9 (PHQ-9)
This is a validated 9-item questionnaire that is used to measure depressive symptoms. A clinically significant improvement in depressive symptoms will be defined by a finding of a statistically significant change of the PHQ-9 score at the time of assessment, compared to the PHQ-9 score at baseline, of each individual. The study population is defined with depressive symptoms: one of the inclusion criteria for the study is a minimum PHQ-9 score of 2 at baseline and a maximum score is 14.
Time frame
From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.2
Rosenberg Self-Esteem Scale (RSE)
The scale is a ten-item Likert scale with items answered on a four-point scale - from strongly agree to strongly disagree. The higher the score, the higher the self-esteem. A successful measurement is defined as a minimum increase of 10% on the score of RSE at baseline.
Time frame
From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.3
Perceived Stress Scale
4\. The Perceived Stress Scale (PSS-10) is a 10-item scale that will be used to measure stress, inquiring how participants felt in the past month and the degree to which life events were experienced and appraised as stressful, with responses ranging from 0 (never) to 4 (very often).
Time frame
From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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