What side effects are associated with this type of intervention?

The most common treatments for stress management being studied in the Personalized Trial include guided mindfulness meditation, guided yoga, and guided brisk walking. Generally, these interventions are considered safe with minimal side effects. Mindfulness meditation and yoga may occasionally cause mild discomfort, such as muscle soreness or temporary emotional distress as individuals confront stressors. Brisk walking is also typically safe but can lead to minor issues like muscle strain or fatigue, especially in individuals who are not accustomed to regular physical activity. Overall, these treatments are low-risk and well-tolerated by most individuals.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs solely for the treatment of stress. However, medications such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines are commonly prescribed off-label to manage symptoms of stress and anxiety. In contrast, the Personalized Trial is exploring non-pharmacological interventions like guided mindfulness meditation, guided yoga, and guided brisk walking, which are not FDA-regulated but have shown promise in improving stress management outcomes.

What other types of research exist?

Promising, novel alternatives to Personalized Trials for stress management in 2024 include: 1) Digital mental health interventions such as mobile apps and online platforms offering cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR). 2) Virtual reality (VR) therapy, which provides immersive environments for relaxation and stress relief. 3) Biofeedback and neurofeedback techniques that help patients gain control over physiological functions to reduce stress. 4) Integrative approaches combining physical exercise, dietary modifications, and psychological support, as evidenced by recent studies on their effectiveness.

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Personalized Stress Management Techniques for Stress

Phase 2

Waitlist Available

Led By Karina Davidson, PhD, MASc

Research Sponsored by Northwell Health

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 ema pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests meditation, yoga, and walking to help people manage stress. It focuses on individuals looking to reduce their stress levels. Participants will try each method to find out which one works best for them.

Who is the study for?

This trial is for adults in the U.S. who feel stressed, can wear a Fitbit, and use a smartphone. They must speak English and score at least 20 on the Perceived Stress Scale. It's not for those with severe illnesses, substance abuse history, upcoming surgeries, or advised against walking or yoga.

What is being tested?

The study tests if 'Personalized Trials' (guided meditation, yoga, brisk walking) tailored to individuals are better than standard stress management techniques. Participants will follow different sequences of these activities or choose without a set order.

What are the potential side effects?

Since this trial involves non-invasive stress management techniques like meditation, yoga, and walking rather than medication or medical procedures; side effects may include muscle soreness from physical activity but are generally minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ema mood will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ema mood will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ema mood will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.

Secondary study objectives

Agreement of Intervention Selection Between Participant and Researcher.

Change in Mean Within-Subject Difference in Weekly Perceived Stress.

Mean System Usability Score (SUS).

+7 more

Other study objectives

Descriptive Content of Qualitative Interview Data

Mean Fitbit Device Adherence Rate.

Mean Participant Ecological Momentary Assessment (EMA) adherence rate.

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Personalized Trial CBAABCExperimental Treatment1 Intervention

Participants in Arm 2 will receive a Personalized Trial of the 3 stress management interventions in a CBAABC treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of the study-provided stress management content each week.

Group II: Personalized Trial ABCCBAExperimental Treatment1 Intervention

Participants in Arm 1 will receive a Personalized Trial of the 3 stress management interventions in an ABCCBA treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of study-provided stress management content each week.

Group III: Standard CareActive Control1 Intervention

Participants in Arm 3 will receive Standard Care of the 3 stress management techniques (mindfulness meditation, yoga, and brisk walking). Participants will receive access to the same number of views of the mindfulness meditation, yoga, and brisk walking content given to participants randomized in Arm 1 and Arm 2. However, they will not be prompted to complete any session according to a randomization sequence. A link to the stress management video will be delivered via text 1 time per week to the participant. Participants will be limited to 36 total views of study-provided stress management content (12 total views per stress management technique).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Personalized Trial ABCCBA

2022

Completed Phase 2

~220

Personalized Trial CBAABC

2022

Completed Phase 2

~220

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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

The most common treatments for stress management, such as guided mindfulness meditation, guided yoga, and guided brisk walking, work through different mechanisms to alleviate stress. Mindfulness meditation helps by promoting awareness and acceptance of the present moment, reducing the physiological and psychological impact of stress. Yoga combines physical postures, breathing exercises, and meditation to enhance physical flexibility, strength, and mental clarity, which collectively reduce stress levels. Brisk walking, a form of aerobic exercise, increases endorphin production, improves mood, and reduces anxiety. These treatments are important for stress patients as they offer non-pharmacological options that can be personalized to individual preferences and needs, potentially leading to better adherence and outcomes.

Mode-specific effects among three treatments for depression.