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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment ACTivity, Relaxercise for depression?

Research shows that exercise can help reduce symptoms of depression, even if it's not aerobic exercise. Many people with depression find exercise to be a valuable part of their treatment, and those who keep exercising often feel better than those who don't. ^{1 2 3 4 5}

Is the ACT-based Physical Activity Program for Depression safe for humans?

Exercise, including aerobic and resistance training, is generally safe for people with depression and is often recommended as part of treatment. Studies have shown that exercise can improve mood and is well-tolerated by patients, with no significant adverse events reported. ^{2 6 7 8 9}

How does the ACT-based Physical Activity Program for Depression differ from other treatments for depression?

The ACT-based Physical Activity Program for Depression is unique because it combines physical activity with Acceptance and Commitment Therapy (ACT), which focuses on accepting thoughts and feelings rather than fighting them. This approach is different from traditional treatments like medication or standard psychotherapy, as it emphasizes both physical movement and psychological flexibility to help reduce depressive symptoms. ^{2 8 10 11 12}

Research Team

Da M Wil, Ph.D.

Principal Investigator

Brown University School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Benefits of exercise for the treatment of depression. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Project MOVE: A randomized controlled trial of Interventions for initiating and maintaining physical activity in depressed individuals. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Perceived barriers, benefits and correlates of physical activity in outpatients with Major Depressive Disorder: A study from Brazil. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Leisure time physical activity and its relation to psychiatric comorbidities in depression. Findings from Finnish Depression and Metabolic Syndrome in Adults (FDMSA) study. [2020]

6. England 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. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

The effects of exercise on oxidative stress (TBARS) and BDNF in severely depressed inpatients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise and Depressive Disorder. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Level and timing of physical activity during normal daily life in depressed and non-depressed individuals. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Walk on the bright side: physical activity and affect in major depressive disorder. [2022]