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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual therapy to improve sleep issues in young people with Down syndrome. Researchers compare two approaches: Mindfulness-Based Therapy for Insomnia and Brief Behavioral Therapy for Insomnia, to determine which is more effective. The trial also examines how improving sleep for both the person with Down syndrome and their caregiver affects overall outcomes. Individuals with Down syndrome who experience sleep disturbances, such as difficulty falling or staying asleep most nights, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance sleep therapies for individuals with Down syndrome and their caregivers.

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 prior data suggests that this protocol is safe for individuals with Down syndrome?

Research has shown that mindfulness-based therapies are generally easy for participants to handle and tend to cause fewer side effects than medication-based treatments. Studies of similar programs, such as Mindfulness-Based Therapy for Insomnia (MBTI), have demonstrated promising results in improving sleep without significant issues.

Mindfulness-based approaches emphasize relaxation and awareness, offering gentle and low-risk options. Some individuals might experience mild discomfort, such as temporarily heightened stress awareness, but this usually subsides quickly.

In this trial, the treatment is specifically designed for individuals with Down syndrome, considering their unique needs. The therapy incorporates visual aids and shorter sessions, making it even more accessible. Research supports that these tailored mindfulness programs are safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome because it offers a non-pharmacological approach to managing insomnia, differing from traditional treatments like medication. MBTI focuses on mental practices, helping individuals develop skills to manage stress and improve sleep through mindfulness techniques delivered in structured sessions. This approach is particularly engaging because it emphasizes self-regulation and mind-body awareness, potentially offering sustainable, long-term improvements in sleep quality without the side effects commonly associated with sleep medications.

What evidence suggests that Mindfulness-Based Therapy for Insomnia could be effective for improving sleep in individuals with Down syndrome?

Research shows that Mindfulness-Based Therapy for Insomnia (MBTI) can help with sleep problems. In past studies, MBTI proved more effective in reducing insomnia than standard sleep education. For people with Down syndrome, behavioral sleep treatments like MBTI effectively address sleep issues. This trial will evaluate MBTI, providing participants with the intervention over 8 sessions. The therapy uses mindfulness techniques to promote relaxation and better sleep habits. These findings suggest that MBTI could be a promising way to improve sleep quality in young people with Down syndrome. ^{1 2 3 4 6}

Who Is on the Research Team?

Caroline G Richter, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

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

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

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06783725

Sleep Intervention and Quality of Life in Down Syndrome This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people ...

2. trialx.com trialx.com/clinical-trials/listings/305661/sleep-intervention-and-quality-of-life-in-down-syndrome/

Sleep Intervention and Quality of Life in Down Syndrome This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/512/downs-syndrome

Down's Syndrome Clinical Research Trials This study aims to address the significant gap in effective behavioral treatments for sleep problems in individuals with Down syndrome (DS).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8867746/

Randomized behavioral sleep clinical trial to improve ... A small-scale randomized clinical trial of a behavioral sleep treatment designed specifically for children with Down syndrome.

5. withpower.com withpower.com/trial/phase-down-syndrome-2-2025-e9a8c?condition=&query=Mindfulness-Based+Intervention&overallStatus=Recruiting&hasNoPlacebo=false

Mindfulness-Based Therapy for Insomnia for Down ... Mindfulness-based cognitive therapy for insomnia (MBCT-I) showed a significant short-term reduction in insomnia severity compared to a sleep psycho-education ...

6. uabccts.trialstoday.org uabccts.trialstoday.org/trial/NCT06783725

Sleep Intervention and Quality of Life in Down Syndrome This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) ...