Online Yoga vs. Behavioral Therapy for Depression

Recruiting at 1 trial location

Overseen By Ingrid R. Hsu, BA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe heart failure, Lung disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares online group yoga classes and one-on-one online therapy sessions for adults with significant depression. Yoga reduces stress and promotes relaxation, while therapy encourages activities that improve mood. Yoga has been explored as a complementary treatment for depression and anxiety, showing potential benefits in enhancing engagement and perceived clinical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Online Yoga vs. Behavioral Therapy for Depression?

Research shows that behavioral activation (BA), a key component of the treatment, is effective for depression, with studies indicating it can be as effective as antidepressant medication for severe cases and beneficial in the long term. Additionally, internet-based BA has been shown to be effective, making it suitable for online delivery. ^{1 2 3 4 5}

Is online yoga or behavioral therapy safe for humans?

Behavioral activation therapy, whether delivered online or in groups, has a dropout rate similar to other depression treatments, suggesting it is generally safe. Yoga, as a treatment for depression, is considered an alternative option with no specific safety concerns mentioned in the studies. ^{1 2 6 7 8}

How is the Online Yoga vs. Behavioral Therapy treatment for depression different from other treatments?

This treatment is unique because it combines online yoga and behavioral activation therapy, which can be delivered over the internet, making it accessible and convenient. Unlike traditional therapies that require in-person sessions, this approach allows for flexibility and can be administered by therapists with less specialized training. ^{5 6 7 9 10}

Research Team

Louisa Sylvia, PhD

Principal Investigator

Massachusetts General Hospital

Lisa Uebelacker, PhD

Principal Investigator

Butler Hospital

Eligibility Criteria

Adults with depression (PHQ-9 score ≥10) who can read English or Spanish, live in NC, MA, MN, or RI and have a healthcare provider. Not for those with recent bone fractures/joint surgery, severe heart/lung disease, advised against exercise by a doctor, currently pregnant or engaged in yoga/psychotherapy recently.

Inclusion Criteria

Live in NC, MA, MN, or RI

Has a healthcare provider (a primary care provider, clinic, or mental health care provider) whom the participant could contact if medical care were needed

Provides informed consent

Exclusion Criteria

I have been practicing yoga or attending psychotherapy sessions regularly in the past month.

I am unable to walk.

I am currently experiencing high mood or mania.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a yoga-based intervention or Behavioral Activation therapy over a 12-week period

12 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Assessments at weeks 18 and 24 (virtual)

Treatment Details

Interventions

• Online- BA (Behavioural Intervention)
• Online- Yoga-based Intervention (Behavioural Intervention)

Trial Overview This study compares an online group-based yoga program to individualized behavioral therapy (BA) for depression over 12 weeks. Participants will be randomly assigned to either the yoga or BA group and assessed at multiple points during and after treatment.

Participant Groups

Group I: Behavioral Activation Active Control 1 Intervention

The goal of Behavioral Activation Psychotherapy is to help people identify and (re)engage in meaningful and positive activities through psychoeducation, identification of values and associated activities, goal setting, problem-solving, and monitoring of goal completion. There will be a BA manual for therapists and training provided by study staff on the manual (e.g., asynchronous and synchronous training sessions). BA therapists will be community clinicians. BA will be provided individually via telehealth and will be billed to participant insurance. At the start of BA treatment, participants will be oriented to the time-limited nature of BA, with the expectation that they will attend 8 sessions over the course of 3 months.

Group II: Yoga-based Intervention Active Control 1 Intervention

Yoga classes will be gentle and physically accessible for people who are naïve to yoga. Teachers will frequently guide participants to focus on their breathing and coordinate movements with breath. Teachers will offer variations on the postures and encourage participants to choose variations that provide some challenge but do not cause strain or pain. Classes will be 1 hour long and include a brief sitting meditation, warm-ups, standing postures, and a final resting meditation. All participants will be invited to attend a synchronous yoga class via a HIPAA-compliant videoconference option once per week during the first 3 months of the study. Classes will be offered at multiple times throughout the week.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Butler Hospital

Collaborator

Trials

133

Recruited

16,700+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Hennepin Healthcare Research Institute

Collaborator

Trials

94

Recruited

77,100+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Findings from Research

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

Group behavioral activation (BA) significantly improves depression outcomes compared to control groups, with a moderate to large effect size (SMD 0.72) based on 19 trials involving 461 participants.

The dropout rate for group BA (14%) is comparable to other active depression treatments (17%), indicating that it is an acceptable treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Efficacy of Group Behavioral Activation for Depression Among Adults: A Meta-Analysis. Simmonds-Buckley, M., Kellett, S., Waller, G.[2019]

The brief behavioral activation treatment for depression is a simple and cost-effective method aimed at increasing exposure to positive activities, which can improve mood and thoughts.

This treatment is based on behavioral theory and recent evidence suggesting that the behavioral component is key to achieving positive changes in cognitive-behavioral therapies for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief behavioral activation treatment for depression. Treatment manual. Lejuez, CW., Hopko, DR., Hopko, SD.[2022]

Behavioral activation therapy (BA) has been shown to be more effective than cognitive therapy and comparable to antidepressant medication for treating severe depression, based on a large-scale study from Washington University in St. Louis.

BA is recommended as a first-line treatment for mild to moderate depression due to its simplicity and time efficiency, although further research is needed to optimize its application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence for the Efficacy of Behavioral Activation against Depressive Disorder: A Literature Review]. Kuroki, T., Ishibashi, H.[2018]

An 8-week internet-based behavioral activation (BA) program combined with acceptance and commitment therapy (ACT) showed a large effect in reducing depression symptoms, with a significant effect size of d=0.98 based on the Beck Depression Inventory II among 80 participants.

25% of participants in the treatment group achieved remission (BDI score ≤ 10) compared to only 5% in the waiting list control group, indicating the potential efficacy of this online intervention for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based behavioral activation and acceptance-based treatment for depression: a randomized controlled trial. Carlbring, P., Hägglund, M., Luthström, A., et al.[2022]

A study involving 128 participants with major depressive episodes found that a Health Action Process Approach (HAPA)-based internet-delivered behavioral activation intervention significantly reduced clinician-rated depressive symptoms compared to a control group, with a strong effect size at 8 weeks (d = 0.79).

The intervention group also showed improvements in self-rated depressive symptoms, behavioral activation, and various motivational and volitional outcomes, indicating that the HAPA framework effectively enhances treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. Mueller-Weinitschke, C., Bengel, J., Baumeister, H., et al.[2023]

An 8-week hatha yoga intervention significantly reduced depression severity in adults with mild-to-moderate major depression, showing a large effect size (Cohen's d = -0.96) compared to a control group.

Participants in the yoga group were more likely to achieve remission from depression, with a significant decline in Beck Depression Inventory (BDI) scores, indicating that yoga can be an effective alternative treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating major depression with yoga: A prospective, randomized, controlled pilot trial. Prathikanti, S., Rivera, R., Cochran, A., et al.[2022]

Behavioral activation has been shown to be more effective than waitlist and treatment-as-usual control groups for treating depression, with effect sizes comparable to cognitive behavior therapy and cognitive therapy.

This treatment may have advantages over pharmacotherapy, such as lower dropout rates, reduced relapse and recurrence, and fewer risks associated with medication, making it a viable option for various populations, including those with severe depression or substance abuse issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation is an evidence-based treatment for depression. Sturmey, P.[2022]

In a study involving 137 out-patients with major depression, those who practiced yoga (either alone or alongside medication) showed significantly greater reductions in depression scores compared to those who only received medication.

No adverse events were reported in patients practicing yoga, suggesting it is a safe and effective complementary treatment for depression in non-suicidal out-patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive antidepressant effects of generic yoga in depressive out-patients: A comparative study. Gangadhar, BN., Naveen, GH., Rao, MG., et al.[2021]

A randomized controlled trial involving 47 participants showed that behavioral activation is significantly more effective than treatment as usual in reducing depression symptoms, with a notable improvement on the Beck Depression Inventory-II.

The study suggests that behavioral activation can be effectively delivered by generic mental health workers, making it a potentially accessible treatment option for depression that requires less specialized training than cognitive-behavioral therapy (CBT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Ekers, D., Richards, D., McMillan, D., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Acceptability and Efficacy of Group Behavioral Activation for Depression Among Adults: A Meta-Analysis. [2019]

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

A brief behavioral activation treatment for depression. Treatment manual. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

[Evidence for the Efficacy of Behavioral Activation against Depressive Disorder: A Literature Review]. [2018]

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

Internet-based behavioral activation and acceptance-based treatment for depression: a randomized controlled trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. [2023]

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

Treating major depression with yoga: A prospective, randomized, controlled pilot trial. [2022]

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

Behavioral activation is an evidence-based treatment for depression. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Positive antidepressant effects of generic yoga in depressive out-patients: A comparative study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. [2018]