Online Yoga vs. Behavioral Therapy for Depression

Not currently recruiting at 2 trial locations

Overseen By Giuliana M Chau, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe heart failure, Lung disease, others

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

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two online treatments for people with depression: a group-based yoga class and an individualized behavioral therapy called Brief Behavioral Activation (BA). The researchers aim to determine which treatment more effectively improves depressive symptoms. Participants will either join yoga sessions focusing on gentle movements and breathing or BA sessions that encourage engaging in positive activities. Individuals with depressive symptoms living in NC, MA, MN, or RI might be a good fit for this trial, especially if they haven't recently practiced yoga or therapy. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for depression in a flexible, online format.

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.

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

Research has shown that both online Behavioral Activation (BA) and yoga are safe and well-tolerated methods for treating depression. A study on online group BA found it significantly reduced depression symptoms without major side effects. BA is simple and cost-effective, making it a popular therapy choice.

Yoga has also been studied for its impact on depression. A review of studies found that yoga significantly improved depression symptoms. Specifically, another study showed that older adults who practiced web-based Hatha yoga reported feeling less stressed, anxious, and depressed, and they also slept better.

Both treatments have demonstrated promise in reducing depression symptoms with minimal risk, making them safe options for participants in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for depression because they offer unique, accessible approaches. Unlike traditional options like medication or in-person therapy, the yoga-based intervention provides a gentle, physically accessible practice that integrates breathing and movement, delivered online for easy access. Meanwhile, the online Behavioral Activation therapy focuses on helping individuals re-engage in meaningful activities through targeted goal-setting and problem-solving, also available via telehealth. These treatments stand out by being conducted online, making them more accessible to a broader audience and potentially appealing to those seeking non-medication-based therapy.

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

This trial will compare two treatments: Online Behavioral Activation (BA) and an Online Yoga-based Intervention. Research has shown that digital Behavioral Activation (BA), which participants in this trial may receive, can reduce symptoms of depression. People using online BA often experience a better quality of life and fewer signs of depression over time. Specifically, those who participated in at least four therapy sessions noticed a significant drop in their depression levels.

For the yoga-based approach, another treatment option in this trial, studies have found that online Hatha Yoga can improve mental health and sleep quality. A review of research found that mindfulness yoga exercises effectively treat depression and boost mental well-being. Overall, yoga programs have been helpful in improving mental health across different groups. ^{1 6 7 8 9}

Who Is on the Research Team?

Lisa Uebelacker, PhD

Principal Investigator

Butler Hospital

Louisa Sylvia, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Online- BA
• Online- Yoga-based 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.

How Is the Trial Designed?

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.

Online- BA is already approved in United States, European Union for the following indications:

Approved in United States as Brief Behavioral Activation Treatment for Depression for:

• Major Depressive Disorder

Approved in European Union as Behavioral Activation Therapy for:

• Depression

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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