Yoga Therapy versus Cognitive Behavioral Therapy for Chronic Insomnia
- Conditions
- Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
- Registration Number
- CTRI/2020/09/027943
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1-Diagnosed with chronic insomnia as per ICSD-3
2-Has a score >= 15 on the Insomnia Severity Index
3-showed following using a sleep diary data during 1-week screening period:
a-Mean TWT >= 60 m/Night
b-Mean sleep efficiency <85%
4-PHQ score showing moderate MDD at the maximum
1-Urgent medical or psychiatric care required
2-Any suicide attempt in the past 6 months
3-Sleep disruptive co-morbid medical condition.
4-Any co-morbid significant Psychiatric condition and substance use that could worsen insomnia
5-Taking drugs having hypnotic potentials
6-Other sleep disorders that can disrupt sleep
7-Any of the following on baseline polysomnography (PSG):
a- Apnoea-Hypopnea Index > 15
b- Periodic limb movement in sleep > 15
8- Hypnotic dependent
9-Pregnant women
10- MMSE < 24
11-Patients with epilepsy
12-If unable to perform the yoga therapy module
13-Unwilling to enroll for CBT-I
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia treatment response (ISI total score reduction more than 6 points from baseline) <br/ ><br>Timepoint: 4 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1- Insomnia Remission (ISI total score less than 11) <br/ ><br>2- Improvement in mood symptoms <br/ ><br>3-Improvement in DBAS- 16 <br/ ><br>4-Improvement in measures of hyperarousal <br/ ><br>5-Improvement in Sleep onset latency, Total Wake Time, Sleep Efficiency <br/ ><br>6-Reduction of use of hypnotic medication (Cumulative dose/ week) <br/ ><br>Timepoint: 4 months