What side effects are associated with this type of intervention?

Common treatments for depression that focus on stress reduction, improved mood, and increased physical activity, such as mindfulness-based stress reduction (MBSR), cognitive behavioral therapy (CBT), and aerobic exercise, generally have minimal side effects. MBSR and CBT may occasionally cause temporary increases in anxiety or emotional discomfort as individuals confront distressing thoughts and feelings. Aerobic exercise can lead to physical side effects such as muscle soreness or fatigue, particularly in those who are not accustomed to regular physical activity. Antidepressant medications, often used alongside these therapies, can have side effects including nausea, weight gain, sexual dysfunction, and insomnia. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for depression that align with the benefits of yoga, including antidepressants like SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., venlafaxine, duloxetine), which help improve mood and reduce stress. Additionally, exercise has been recognized for its moderate clinical benefits in treating depression, promoting physical activity, and enhancing overall well-being. While yoga itself is not FDA-approved, its components of stress reduction and physical activity are supported by these approved treatments.

What other types of research exist?

Promising novel alternatives to yoga for depression patients include: 1) Mindfulness-Based Stress Reduction (MBSR), which has shown broad symptom improvement in breast cancer survivors and can be adapted for depression; 2) Behavioral Activation Therapy, which is an evidence-based behavioral therapy for depression; 3) Acupuncture, which has been effective in reducing joint pain and may have mood-enhancing benefits; 4) Qigong, which has improved quality of life and reduced fatigue and mood disturbances in cancer patients; and 5) Guided Imagery and Progressive Muscle Relaxation, which have been effective in reducing pain and improving psychological symptoms in cancer patients.

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Online Yoga vs. Behavioral Therapy for Depression

N/A

Recruiting

Led By Louisa Sylvia, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week: 0, 6, 12, 18, 24

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include typical risks associated with physical activity like muscle strain for the yoga intervention. Behavioral Activation Therapy generally has minimal side effects but could include emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week: 0, 6, 12, 18, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week: 0, 6, 12, 18, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week: 0, 6, 12, 18, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Health Questionnaire-9 (PHQ-9)

Secondary study objectives

PROMIS-29 Anxiety Subscale

PROMIS-29 Sleep Subscale

World Health Organization-5 Well-Being Index (WHO-5)

Other study objectives

PROMIS Anger

PROMIS-29 Pain Interference

PROMIS-29 Physical Functioning Subscale

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Behavioral ActivationActive Control1 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 InterventionActive Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as yoga and behavioral therapies, work through several mechanisms. Yoga and similar practices reduce stress by lowering cortisol levels and promoting relaxation, which can alleviate symptoms of anxiety and depression. These activities also improve mood by increasing the production of endorphins and serotonin, neurotransmitters associated with feelings of well-being and happiness. Additionally, the physical activity involved in yoga enhances overall physical health, which can lead to better mental health outcomes. For depression patients, these mechanisms are crucial as they address both the psychological and physiological aspects of the disorder, providing a holistic approach to treatment.