An exploratory randomized controlled trial protocol evaluating Cognitive Behavioral Therapy for Insomnia with adjunct Ayurvedic external therapies (Siro-pichu and Padabhyanga) in perimenopausal women
Exploratory trial examines the effects of CBT and Ayurvedic therapies on insomnia in perimenopausal women, highlighting treatment feasibility.
Key Points
This study aims to explore the feasibility and preliminary effectiveness of combining CBT for insomnia with Ayurvedic therapies in perimenopausal women.
Conducted as a single-center, parallel-group, exploratory randomized controlled trial.
Included sixty-two perimenopausal women aged 45-55 with subthreshold to moderate insomnia.
Participants received standardized CBT-I for 4 weeks; the integrative arm received additional Ayurvedic therapies.
Siro-pichu was administered for seven days, and Padabhyanga for fourteen days, starting at baseline.
Change in insomnia severity index (ISI) score will be assessed at Week 4 as the primary outcome.
Secondary outcomes will evaluate early response at Week 2 and changes in sleep quality over 3 months of follow-up.
Exploratory measures include safety, treatment adherence, and behavioral dependency risk.