Mindfulness-Based Therapy for Insomnia for Down Syndrome

(SleepDS Trial)

Overseen By Sylvie Mrug, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe sensory or motor impairments, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS and sleep medicine to ensure that the intervention protocol is relevant and appropriate for young people with DS (age 12 and older). Planned adaptations include 1) utilization of visual aids and videos to increase engagement and reinforce mindfulness concepts and practices; 2) shortened meditation practices to accommodate concentration limits of individuals with DS; 3) caregiver involvement reflecting the important role of caregivers in daily functioning of individuals with DS; 4) adapted homework to cater to the learning styles of individuals with DS; 5) daily reminders to encourage regular practice and reinforce the importance of consistency; and 6) modified session structure to ensure that participants are able to discuss their experiences and refine their mindfulness practice. During the first 6 months of the project, the investigators will meet monthly with the community advisory board and use an iterative process to develop detailed intervention protocol for a virtual MBTI suitable for young people with DS. Aim 2 of the project will be to pilot test the efficacy of the virtual MBTI for young people with DS. In the second half of the one-year project, the investigators will conduct a pilot randomized clinical trial (RCT) of the intervention developed in Aim 1. This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people with Down syndrome (DS). The interventions will be compared on their impact on improving sleep problems, quality of life, and functional outcomes. This project will also test if targeting the sleep of the caregiver in addition to the individual with Down syndrome has any effect on the outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial organizers or your healthcare provider for guidance.

What data supports the effectiveness of the treatment Mindfulness-Based Therapy for Insomnia for Down Syndrome?

Research shows that mindfulness-based therapies, which include meditation and self-regulation practices, can help improve sleep and reduce insomnia symptoms. These therapies have been effective in treating insomnia by reducing stress and improving emotional regulation, which are key factors in sleep disturbances. ^{1 2 3 4 5}

Is mindfulness-based therapy for insomnia safe for humans?

Mindfulness-based therapy for insomnia is generally considered safe for humans, as it is a non-drug approach that focuses on meditation and self-regulation practices to improve sleep and reduce stress. ^{1 2 4 5 6}

How is Mindfulness-Based Therapy for Insomnia different from other treatments for insomnia?

Mindfulness-Based Therapy for Insomnia is unique because it combines behavioral treatments for insomnia with mindfulness meditation practices, which help individuals manage stress and emotions, potentially improving sleep quality without medication. ^{1 2 3 4 7}

Research Team

Caroline G Richter, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for young individuals aged 12 and older with Down syndrome who experience sleep problems. Caregivers will also be involved in the therapy process. Participants must have a stable living situation and internet access for virtual sessions.

Inclusion Criteria

I have been diagnosed with Down syndrome.

I experience sleep problems most nights, as noted by someone who cares for me.

Nonverbal mental age of at least 36 months, as determined by a baseline measure of adaptive skills

Exclusion Criteria

Inability to complete assessments or participate in the intervention sessions due to behavioral or medical conditions

I am not currently participating in any other sleep or behavioral studies.

Caregiver inability or unwillingness to provide accurate reports or assist in intervention activities as needed

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of the virtual Mindfulness-Based Therapy for Insomnia (MBTI) protocol with community advisory board

6 months

Treatment

Participants receive the MBTI intervention over 8 sessions, one session per week

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for sleep quality and quality of life improvements

1 week

Treatment Details

Interventions

• Mindfulness-Based Therapy for Insomnia

Trial Overview The study tests an adapted Mindfulness-Based Therapy for Insomnia (MBTI) against a control group on wait-list to see if it improves sleep quality, life quality, and daily functioning in those with Down syndrome.

Participant Groups

Group I: Mindfulness-Based Therapy for Insomnia Experimental Treatment 1 Intervention

Individuals with Down syndrome will receive the MBTI intervention over 8 sessions lasting 1 hour over 8 weeks (one session per week). One trained graduate research assistant will deliver the intervention with supervision of a licensed Clinical Psychologist.

Group II: Wait-list control Placebo Group 1 Intervention

The control group will do the pre and post assessments but will not be part of any intervention. The wait-list control group will receive the MBTI intervention after the post-intervention measures are completed.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Mindfulness-based cognitive therapy for insomnia (MBCT-I) showed a significant short-term reduction in insomnia severity compared to a sleep psycho-education with exercise control (PEEC) group, with a notable effect size at 2 months.

While MBCT-I improved wake time after sleep onset at 2 and 5 months, both MBCT-I and PEEC groups exhibited similar long-term improvements in sleep parameters by 8 months, indicating that MBCT-I may not provide sustained benefits over PEEC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial. Wong, SY., Zhang, DX., Li, CC., et al.[2022]

Mindfulness-based therapy for insomnia (MBT-I) combines behavioral treatments with mindfulness meditation to help individuals with chronic sleep disturbances.

Preliminary evidence suggests that MBT-I can effectively aid in emotion regulation and stress reduction, offering a novel approach to managing insomnia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based approach to the treatment of insomnia. Ong, J., Sholtes, D.[2021]

Mindfulness-based interventions (MBIs) have been shown to effectively improve sleep and reduce cognitive arousal, which are key factors in managing insomnia.

The article suggests that MBIs can be used as an adjunct or alternative treatment to cognitive behavioral therapy for insomnia (CBT-I), highlighting their potential role in enhancing sleep treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as an Adjunct or Alternative to CBT-I. Ong, JC., Kalmbach, DA.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial. [2022]

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

A Meta-Analysis of Mindfulness-Based Therapies for Insomnia and Sleep Disturbance: Moving Towards Processes of Change. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treating subclinical and clinical symptoms of insomnia with a mindfulness-based smartphone application: A pilot study. [2022]

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

A mindfulness-based approach to the treatment of insomnia. [2021]

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

Mindfulness as an Adjunct or Alternative to CBT-I. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects and mechanisms of a mindfulness-based intervention on insomnia. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Insomnia: A Meta-Analysis of Randomized Controlled Trials. [2020]