Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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 4-PHQ score showing moderate MDD at the maximum
Exclusion criteria
Exclusion criteria: 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 11-Patients with epilepsy 12-If unable to perform the yoga therapy module 13-Unwilling to enroll for CBT-I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia treatment response (ISI total score reduction more than 6 points from baseline) Timepoint: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Insomnia Remission (ISI total score less than 11) 2- Improvement in mood symptoms 3-Improvement in DBAS- 16 4-Improvement in measures of hyperarousal 5-Improvement in Sleep onset latency, Total Wake Time, Sleep Efficiency 6-Reduction of use of hypnotic medication (Cumulative dose/ week) Timepoint: 4 months | — |
Countries
India
Contacts
All India Institute of medical sciences Rishikesh