ACT-based Physical Activity Program for Depression

Overseen By Lauren C Bohlen, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Mindfulness practice, BMI, Suicidal thoughts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different physical activity programs can help adults with symptoms of depression. It compares two approaches: ACTivity, which uses Acceptance and Commitment Therapy (ACT) to encourage exercise, and Relaxercise, which focuses on relaxation training along with standard exercise advice. People who feel down and engage in less than 60 minutes of moderate exercise per week might be a good fit. Participants will attend weekly online sessions and receive a 6-month YMCA membership to support their physical activity journey. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can improve mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Commitment Therapy (ACT), used in the ACTivity program, is generally safe and positively impacts people with depression. Studies have found that ACT can significantly improve depression symptoms and increase physical activity. Participants reported a better quality of life and improved stress management. These studies have not reported any major safety issues.

For the Relaxercise program, which combines relaxation techniques with physical activity, specific data is less available. However, similar programs are typically safe and well-received by participants.

Both the ACTivity and Relaxercise programs in this trial aim to increase physical activity, which is generally safe and beneficial for mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for depression because they incorporate unique strategies to boost physical activity, which is a key factor in mental health. The ACTivity program uses Acceptance and Commitment Therapy (ACT) to enhance motivation for physical activity, encouraging individuals to embrace their thoughts and feelings while committing to behavior changes. This approach is different from traditional depression treatments, which often focus more on medication or cognitive-behavioral therapy. Meanwhile, Relaxercise combines relaxation techniques with standard physical activity promotion, offering a holistic way to engage the body and mind. These programs aim to provide more personalized and potentially effective alternatives to traditional methods, sparking interest in their potential benefits.

What evidence suggests that this trial's treatments could be effective for depression?

This trial will compare two approaches: ACTivity and Relaxercise. Research has shown that Acceptance and Commitment Therapy (ACT), part of the ACTivity arm in this trial, can significantly improve depression symptoms and enhance mental adaptability. Past studies combining ACT with exercise have demonstrated positive effects on mental health and physical fitness, lasting up to six months post-treatment.

The Relaxercise approach, another arm in this trial, includes relaxation training and regular physical activity. Research has proven that exercise alone, such as walking, yoga, and strength training, can effectively treat depression and noticeably boost mood. Longer and more intense exercise sessions further reduce depression symptoms.

Both treatments in this trial use physical activity to ease depression, with ACTivity adding mental strategies and Relaxercise focusing on the well-known benefits of exercise. ^{2 4 6 7 8}

Who Is on the Research Team?

Da M Wil, Ph.D.

Principal Investigator

Brown University School of Public Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with depressive symptoms who are not very active (less than 60 minutes of moderate exercise per week). They must be able to attend weekly virtual sessions and have a stable Rhode Island address. Exclusions include extreme BMI, conditions limiting physical activity, active suicidal thoughts, participation in other related studies, non-English speakers, and regular mindfulness practitioners.

Inclusion Criteria

You are not physically active and do not engage in moderate exercise for at least 60 minutes per week.

Elevated depressive symptoms (CES-D score of greater than or equal to 10)

Willing and able to attend weekly virtual video sessions via Zoom

Exclusion Criteria

Your body weight is too low or too high for this study.

You have a medical condition that could make physical activity risky for you.

You are currently thinking about or trying to harm yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ACT-based physical activity promotion or Relaxercise for 8 weeks

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in depression symptoms and physical activity over 6 months

6 months

Monthly check-ins

What Are the Treatments Tested in This Trial?

Interventions

• ACTivity
• Relaxercise

Trial Overview The study compares an acceptance and commitment therapy program aimed at increasing physical activity (ACTivity) against a standard physical activity education plus relaxation training (Relaxercise). Participants will be randomly assigned to one of these two groups for an 8-week treatment period and followed up for six months.

How Is the Trial Designed?

Group I: ACTivity Experimental Treatment 1 Intervention

Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Group II: Relaxercise Active Control 1 Intervention

Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Center for Complementary and Integrative Health (NIH)

Collaborator

Trials

1

Recruited

80+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Physical activity interventions have a moderate and significant antidepressant effect on adolescents with depression, with an effect size of -0.47 based on a meta-analysis of 9 studies involving 431 participants.

To maximize effectiveness, physical activity sessions should be of at least moderate intensity, and while the treatments are generally well accepted, the low quality of the studies suggests that further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. Oberste, M., Medele, M., Javelle, F., et al.[2023]

Depressed patients often have low physical fitness due to inactivity, suggesting that incorporating physical fitness training into treatment for depression could be beneficial.

Exercise, including both aerobic and nonaerobic forms, has been shown to have antidepressant effects in patients with mild to moderate depression, and many patients continue exercising after treatment, leading to lower depression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of exercise for the treatment of depression. Martinsen, EW.[2022]

This systematic review aims to evaluate how different types of exercise—specifically aerobic, resistance, and meditative movement—affect sleep quality in patients with unipolar depression, using a comprehensive search of multiple databases and rigorous methodology.

The study will assess not only sleep quality but also secondary outcomes like sleep duration, daytime functioning, and the use of sleep medications, providing a thorough understanding of the potential benefits and risks of exercise interventions for improving sleep in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of aerobic, resistance, and meditative movement exercise on sleep in individuals with depression: protocol for a systematic review and network meta-analysis. Brupbacher, G., Gerger, H., Wechsler, M., et al.[2023]

In a study of 258 patients with clinically confirmed depression, baseline leisure-time physical activity (LTPA) did not significantly influence the five-year prognosis for recovery from depression, as 29% still exhibited depressive symptoms at follow-up.

However, higher levels of baseline LTPA were linked to increased total physical activity after five years, suggesting that promoting physical activity could be beneficial for overall health management in depressed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does baseline leisure-time physical activity level predict future depressive symptoms or physical activity among depressive patients? Findings from a Finnish five-year cohort study. Raatikainen, I., Mäntyselkä, P., Heinonen, A., et al.[2022]

A randomized controlled trial with 242 depressed adults found that combining brief advice with supervised and home-based aerobic exercise and cognitive-behavioral sessions significantly increased moderate-to-vigorous physical activity (MVPA) at 3 months.

While the intervention was effective in the short term, the benefits in increasing aerobic exercise did not persist at 6 or 9 months, indicating a need for ongoing support to maintain activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project MOVE: A randomized controlled trial of Interventions for initiating and maintaining physical activity in depressed individuals. Uebelacker, LA., Epstein-Lubow, G., Sillice, MA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40020954/

Effects of acceptance and commitment therapy plus ... ACT+Ex significantly improved pain intensity, disability, psychological inflexibility, HRQoL, and physical fitness at post-treatment and 6-month follow-up.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212144720301630

Acceptance and Commitment Therapy on physical activity This study aimed to provide a systematic review on the application of ACT for increased PA and adherence to a PA regimen.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10293686/

An Overview of Reviews on the Effects of Acceptance and ... Most studies found that after an ACT treatment mental health symptoms including depression and anxiety alleviated and psychological flexibility increased.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590025005772

Effects of acceptance and commitment therapy plus ... ACT+Ex significantly improved pain intensity, disability, psychological inflexibility, HRQoL, and physical fitness at post-treatment and 6-month follow-up.

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-07067-w

Effects of acceptance and commitment therapy on negative ... ACT appears to significantly improve depressive symptoms, anxiety, and psychological flexibility in individuals with depression.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10465112/

Testing the Feasibility and Acceptability of ... - PubMed Central Acceptance and Commitment Therapy (ACT) may offer promise for increasing PA among adults with depressive symptoms due to its effects on distress tolerance and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5865382/

Exercise combined with Acceptance and Commitment ... Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, ...

8. contextualconsulting.co.uk contextualconsulting.co.uk/resources/promising-findings-act-for-physical-activity-a-systematic-review

Promising findings: ACT for physical activity - a systematic ... The results indicated that ACT showed promising outcomes in increasing physical activity levels and maintaining changes during follow-up. All studies ...