The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy

Insomnia Clinical Trial

— RESTING  

Official title:

Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532282
• Other study ID #: 45874
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.

Description:

All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• insomnia disorder

Exclusion Criteria:

• Unable to be consented in English without an interpreter

• In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score < 25)

• Unable to use the internet

• Study physician determines participation is not medically advised for any reason

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• ONLINE ONLY
Access to an online cognitive behavioral therapy for insomnia
• STEPPED CARE
A two step treatment that starts with either an online or therapist led cognitive behavioral therapy for insomnia, depending on a decision algorithm. Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Insomnia Severity Index (ISI)	Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity	at baseline and at months 2, 4, 6, 9, & 12
Primary	Change in the use of prescription sleep medication	the number of minimal effective doses of a given sleep medication over 7 nights; A greater number means that a person is taking more sleep medication, with a value of 0 meaning that the person is not taking any sleep medication.	at baseline and at months 2, 4, 6, 9, & 12
Secondary	Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) - sleep related impairment questionnaire	Questionnaire measuring sleep related impairment. The range of scores is 8 to 40, with higher score representing greater perceived impairment in function related to sleep.	at baseline and at months 2, 4, 6, 9, & 12
Secondary	Change in the PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)	A validated questionnaire measuring depressive and anxiety symptom severity. The total score ranges between 0 and 12. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).	at baseline and at months 2, 4, 6, 9, & 12