A-B-C Program for Sedentary Older Adults With Depressive Symptoms

NCT07176637 | Not Yet Recruiting

• 2 other identifiers: 273ROH-24-004
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sedentary Older Adults; Sedentariness and Well-being; Sedentary; Aging

Keywords

sedentary older adults; depressive symptoms; behavioural economics; A-B-C Program; physical activity; decision making; automatic thoughts; cognitive biases

Outcome Measures

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.

  From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.

Secondary Outcomes (3)

• Patient Health Questionnaire 9 (PHQ-9)

  From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.

• Rosenberg Self-Esteem Scale (RSE)

  From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.

• Perceived Stress Scale

  From enrollment to the end of treatment at 4 weeks (post-intervention); every 3 months up to 12 months post-intervention.

Study Arms (2)

A-B-C Group

EXPERIMENTAL

The intervention group will be led by Dr. Klil-Drori, a staff academic psychiatrist in the Geriatric Department at The Royal Ottawa Mental Health Centre. Dr. Klil-Drori completed clinical and research postdoctoral fellowships at McGill University and the University of Toronto, and developed the "A-B-C" program. The "A-B-C" program is a structured group intervention that meets twice weekly for four weeks, with each session lasting 60 minutes. Small groups of five participants will be facilitated by Dr. Klil-Drori. The program covers topics such as automatic thoughts and their associated emotions, common cognitive distortions (or cognitive biases), and how these influence decision-making and behaviour. Concepts introduced during sessions will be reinforced through structured group discussions and daily home practice assignments. The full outline for the A-B-C program, and the program journal can be found in 'Other Documents'.

Behavioral: A-B-C Program

Physical activity education

ACTIVE COMPARATOR

The 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.

Other: Physical Activity Educational Program

Interventions

A-B-C Program BEHAVIORAL

The 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.

A-B-C Group

Physical Activity Educational Program OTHER

The 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.

Physical activity education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. 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.
• \. Score on the PHQ-9 is between 2-14. 5. The participant agrees to attend all the meetings for the duration of the study, and to practice home assignments.
• \. Adequate command of English to be able to participate in the group sessions. 7. Current weekly duration of exercise\* ≤60 minutes/week. (\*Exercise: a specific type of physical activity \[PA\], which is structured, and has the intention of improving either health or fitness. Exercise differs from PA, which includes any physical effort, however without the intention of improving health or fitness \[e.g., driving, cleaning, standing, etc. are examples for PA, not exercise\]) 8. Participants have interest in increasing their weekly time of physical activity, and willingness to practice skills learned during the program.
• \. Agree to participate in any of the study groups according to a randomized allocation.

You may not qualify if:

• \. 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).
• \. Patients currently involved in routine intensive exercise\* \> 1 hour/ week. 7. Lack of interest to increase their daily time of physical activity 8. Refuse to participate in any of the study groups according to a randomized allocation.
• \. PHQ-9 score less than 2, or greater than 14.

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

MeSH Terms

Conditions

Sedentary Behavior; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Central Study Contacts

Sivan Klil-Drori, MD

CONTACT

(613) 722-6521; sivan.klil-drori@theroyal.ca

Anvita D Gupta, MSc

CONTACT

(613) 722-6521; anvita.gupta@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share