Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The recommended treatment for insomnia, cognitive behavioral therapy for insomnia (CBT-I), is effective. However, its long, multi-component nature makes it challenging to implement in ordinary primary care, where most people are treated. An important component of CBT-I is sleep restriction therapy, which may be comparatively easy to carry out in routine primary care. This project tests whether a brief nurse-led group intervention in primary care based on sleep restriction therapy for insomnia reduces insomnia severity and is cost-effective.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Fulfills the DSM-5 diagnostic criteria for insomnia disorder: a) Difficulty initiating sleep, difficulty maintaining sleep, and early morning awakenings despite adequate opportunity for sleep (e.g., adequate time and circumstances for sleep and a safe, quiet, and dark bedroom). b) The sleep difficulties cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. c) The sleep difficulties occur at least 3 nights per week and have been present for at least 3 months. d) The symptoms are not better explained by and do not occur exclusively during the course of another sleep-wake disorder. e) The symptoms cannot be attributed to the effects of a substance (e.g., drug abuse and medication). f) Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.

Locations
Other Locations
Sweden
Christina Sandlund
RECRUITING
Stockholm
Contact Information
Primary
Christina Bini, MSc
christina.bini@regionstockholm.se
46738732627
Backup
Christina Sandlund, PhD
christina.sandlund@ki.se
46702796563
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Experimental: Sleep restriction therapy
Four group sessions delivered at the participants' primary health care centers once a week for 3 weeks and again after a 4-week pause. The first session will last for 2 hours and the other sessions for 1 hour.
Active_comparator: Sleep hygiene
Participants in the active comparator group will receive a brochure with sleep hygiene advice from the primary health care center at baseline.
Related Therapeutic Areas
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov