An exploratory randomized controlled trial protocol evaluating Cognitive Behavioral Therapy for Insomnia with adjunct...

Insomnia during perimenopause is a common and clinically significant condition associated with impaired daytime functioning and reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line non-pharmacological treatment in international guidelines; however, symptom improvement may require several weeks, potentially affecting adherence. External Ayurvedic procedures such as Siro-pichu (localized retention of medicated oil over the scalp) and Padabhyanga (therapeutic oil massage of the feet) using Ksirabala Taila are traditionally described as supportive interventions for sleep regulation. The present study is designed to explore the feasibility and preliminary signal of integrating these procedures with CBT-I.

This single-center, parallel-group, exploratory randomized controlled trial (CTRI/2025/11/098172) is conducted at the Amrita School of Ayurveda, Kerala, India, with a 1:1 allocation ratio. Sixty-two perimenopausal women aged 45-55 years with subthreshold to moderate insomnia (Insomnia Severity Index [ISI] 8-21) will receive standardized CBT-I for 4 weeks (both groups). The integrative arm will additionally receive Siro-pichu for seven consecutive days and Padabhyanga for fourteen consecutive days, commencing at baseline. Follow-up continues for 3 months. The exploratory primary outcome is change in ISI score from baseline to Week 4. Exploratory secondary outcomes assess early response (ISI at Week 2), durability of change during follow-up (ISI and PSQI), sleep quality (PSQI), safety (adverse event monitoring), behavioral dependency risk (Severity of Dependence Scale), and treatment adherence (Daily Sleep and Treatment Engagement Diary).

This exploratory trial evaluates feasibility, safety, adherence, and preliminary effect-size estimation within a hypothesis-generating framework. It is not designed to establish confirmatory efficacy or superiority.

The trial was prospectively registered with the Clinical Trials Registry-India (CTRI/2025/11/098172).