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Research summary · 12 d ago

AI summary · not yet reviewedHuman studyPhase 2Trial registry record – peer review not applicable

Telehealth and Web-Based Cognitive Behavioral Therapy for Insomnia in Multiple Sclerosis

This Phase 2 interventional study evaluated the effectiveness of one-on-one telehealth cognitive behavioral therapy for insomnia (tCBT-I) and web-based CBT-I (wCBT-I) against treatment as usual (TAU) in 90 patients. The study aims to measure improvements in sleep outcomes, fatigue, and quality of life over 6 weeks and 6 months.

Tags: #MSResearch
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Source: Read original source

This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.

Human efficacy: Not yet assessed
Mechanism: Not yet assessed
Evidence strength: Not yet assessed
Outcome: Not yet assessed

Why it matters

This research is important as it seeks to address insomnia, a common symptom in multiple sclerosis, by comparing innovative cognitive behavioral therapies and their potential benefits on patient quality of life.

What this does not prove

No results have been posted yet, and the study has planned enrolment and endpoints that cannot be considered findings.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Interventional
Participants / samples: 90 · basis not reported
Randomised: Yes
Controlled: Not applicable
Primary endpoint met: Not reported
Relevant MS type: Not reported
Publication date: Not reported
Evidence reviewed: Trial registry record
Regulatory approval: No
Research areas: Not classified

Original sources

Trial registrationComparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection ↗

Supporting passages (13)

study phase"phases": [ "PHASE2" ]

study design"studyType": "INTERVENTIONAL"

subjects"conditions": [ "Multiple Sclerosis", "Insomnia" ]

sample size"count": 90, "type": "ESTIMATED"

randomized"allocation": "RANDOMIZED"

controlled"type": "OTHER"

regulatory approval"isFdaRegulatedDrug": false, "isFdaRegulatedDevice": false

intervention"description": "1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.",

comparator"Treatment as usual (TAU)"

primary endpoint"measure": "Insomnia Severity Index (ISI)"

follow up"timeFrame": "baseline, Week 6, Month 6"

findings"briefSummary": "The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4).

limitationsPlanned enrolment and endpoints are not findings.

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