What side effects are associated with this type of intervention?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe and well-tolerated, with few reported side effects. However, some individuals may experience temporary increases in anxiety, emotional discomfort, or distress as they become more aware of their thoughts and feelings. Other common treatments for health behaviors, such as Cognitive Behavioral Therapy (CBT), may also cause initial increases in anxiety or emotional discomfort as patients confront challenging thoughts and behaviors. Overall, these side effects are typically mild and transient, and the benefits of these therapies often outweigh the temporary discomfort.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments aimed at improving psychological well-being and managing stress-related health behaviors. Selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and sertraline are commonly prescribed for anxiety and depression, which are often associated with high stress levels. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) like duloxetine have been approved for similar indications. While these medications are effective for many, non-pharmacological interventions like Mindfulness-Based Stress Reduction (MBSR) are increasingly recognized for their benefits in reducing stress and enhancing psychological well-being without the side effects associated with medications.

What other types of research exist?

Promising alternatives to MBSR for reducing stress and improving psychological well-being include: <ol> <li>Cognitive Behavioral Therapy (CBT) - Effective for short-term pain reduction and improving quality of life.</li> <li></li> </ol> Yoga - Shown to improve functioning in children with autism and perceived outcomes in Parkinson's disease. 3. Qigong Massage - Demonstrated improvement in sensory and self-regulation problems in children with autism. 4. Neurofeedback - Used for treating attention-deficit/hyperactivity disorder, autism spectrum disorders, and learning disorders. 5. Guided Imagery - Effective as supportive therapy in cancer treatment and for pain reduction in advanced cancer patients.

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Behavioral Intervention

Online Mindfulness Program for Parents of Children with Autism

N/A

Recruiting

Led By Megan Chang, PhD

Research Sponsored by San Jose State University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates an online mindfulness course designed to help parents of children with autism manage stress and improve their well-being. The study will measure the program's effectiveness by assessing parents' stress levels, sleep quality, and resilience over time. The goal is to see if this online program can be as effective as in-person sessions.

Who is the study for?

This trial is for parents of children aged 6-12 with autism who speak English and haven't had prior mindfulness training or severe mental illness. They shouldn't be in psychotherapy or on medications for health issues, and must commit to an 8-week online program.

What is being tested?

The study tests if an online Mindfulness-Based Stress Reduction (MBSR) program helps parents manage stress, improve resilience, sleep better, and support their child's behavior. It compares results before and after the course using psychological assessments and physical stress measures.

What are the potential side effects?

Since this intervention involves a non-invasive therapy focused on meditation and mindfulness practices, significant side effects are not expected. However, participants may experience emotional discomfort when addressing personal stressors during the program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Connor-Davidson Resilience Scale from baseline to exit evaluation

Change in Connor-Davidson Resilience Scale from baseline to midpoint

Change in Connor-Davidson Resilience Scale from midpoint to exit evaluation

Secondary study objectives

Electrodermal activity (EDA)

Mindfulness Attention Awareness Scale

Parenting Stress Index - 4th edition Short Form

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Online MBSR 1Experimental Treatment1 Intervention

received modified online 8-week group-based MBSR intervention delivered by a UMASS trained MBSR instructor

Group II: Waitlist controlActive Control1 Intervention

On a waiting list to receive the identical intervention as the treatment group after the active treatment group completes.

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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

Mindfulness-Based Stress Reduction (MBSR) and similar treatments work by promoting mindfulness through practices like meditation, body scanning, and yoga. These practices help reduce stress by inducing relaxation and mitigating the body's stress response. They also improve psychological well-being by enhancing emotional regulation, reducing negative thought patterns, and increasing resilience. For patients, understanding these mechanisms is important as it underscores how these treatments can effectively address both mental and physical health aspects, leading to better overall health and quality of life.

Dimensions of distress tolerance and the moderating effects on mindfulness-based stress reduction.