Status:

COMPLETED

Cracking the Code to Better Sleep: A Pioneering Study on Remote Support for Insomnia Relief

Lead Sponsor:

Overcome

Conditions:

Insomnia

Eligibility:

All Genders

18-64 years

Phase:

NA

Brief Summary

The goals of this clinical trial are to assess the feasibility of an internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I) and Motivation Interviewing (MI) intervention for individuals aged...

Detailed Description

The study discusses the prevalence and impact of insomnia, a sleep disorder affecting a significant portion of the population. Insomnia is linked to various health issues, including hypertension, obes...

Eligibility Criteria

Inclusion

  • Adults aged 18-64
  • PHQ-9 score 0-12 indicates no depression, mild or moderate depression
  • GAD-7 score 0-12 indicates no anxiety, mild or moderate anxiety symptoms
  • Individuals with self-reported difficulties initiating or maintaining sleep which are aligned with the DSM-5 insomnia criteria.
  • Access to a computer or mobile with internet connectivity
  • Ability to understand and speak English.
  • Willingness and ability to participate in the internet-based CBT-I programme for five weeks (including the study-related assessments and post-follow-up interview)
  • Willing to provide informed consent.

Exclusion

  • Individuals with a history of severe or chronic insomnia
  • Those with a history of major psychiatric or neurological disorders (dementia, Alzheimer's disease)
  • Those with cognitive impairments
  • Those currently receiving or received CBT-I within the past year
  • Those currently receiving medication for insomnia
  • Individuals with known sleep disorders other than mild-moderate insomnia (sleep apnoea).
  • Individuals suffering from chronic pain
  • Pregnant and breastfeeding women.
  • Not able to understand and respond in the study language.

Key Trial Info

Start Date :

February 24 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 20 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06211075

Start Date

February 24 2024

End Date

March 20 2025

Last Update

July 2 2025

Active Locations (1)

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1

Overcome

Arnside, United Kingdom, LA5 0DP

Cracking the Code to Better Sleep: A Pioneering Study on Remote Support for Insomnia Relief | DecenTrialz