Group Cognitive Behavioral Therapy for Insomnia in Older Adults

NCT03117777 | Withdrawn

• 1 other identifier: 3763
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a quality assurance project to evaluate a therapy program offered to patients in Sleep Disorders Clinic. Group Cognitive Behavioral Therapy for Insomnia (CBT-I) is being offered to older adults. The study will consist of analyzing outcomes of a clinical program. As part of standard clinical process, patients complete measurements of sleep, daytime functioning, fatigue, quality of life, depression and anxiety symptoms before and after the treatment. The proposed study will pool and quantitatively analyze the existing clinical data. Only those program participants who consent to have their data pooled in the data analysis will be considered research subjects. Those patients who decline to have their individual data included in the analysis will continue in the therapeutic group as per usual clinical care standards. CBT-I is a gold standard treatment for people suffering from insomnia but it is difficult to access due to a shortage of trained therapists. Insomnia prevalence increases with age and is a common sleep disturbance in the elderly. Offering the group treatment can increase access and reduce healthcare costs associated with sleep problems in the elderly.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (5)

• Insomnia Severity Index

  a validated questionnaire to assess severity of insomnia symptoms, 7 items

  5 months

• Pittsburgh Sleep Quality Index

  a validated questionnaire about quality of sleep, 19 items

  5 months

• Epworth Sleepiness Scale

  a validated questionnaire about level of daytime sleepiness, 8 items

  5 months

• Dysfunctional Beliefs and Attitudes about Sleep Questionnaire

  a validated questionnaire to assess the patients core beliefs about their sleep, 16 items

  5 months

• Sleep logs

  standard instrument used in cognitive behavioral therapy of insomnia, patient fills out data regarding sleep duration and time-in-bed duration, time to sleep onset, time awake after sleep onset, allows to evaluate sleep patterns and calculate sleep efficiency

  5 months

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale

  5 months

• Short Forms Health Survey SF-36

  5 months

• patient satisfaction survey

  5 months

Interventions

group cognitive behavioral therapy for insomnia BEHAVIORAL

cognitive behavioral therapy for insomnia delivered in group setting for older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 65 years of age and older, who meet diagnostic criteria for insomnia disorder defined as difficulty initiating or maintaining sleep associated with daytime impairment, occurring at least 3 nights per week for at least 3 months.

You may qualify if:

• patients 65 years and older meeting diagnostic criteria for insomnia

You may not qualify if:

• significant physical or cognitive impairment that prevent the patients from participating in behavioural intervention (e.g. getting out of bed on their own) or cognitive intervention (e.g. learning sleep psychoeducation)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Sleep Disorders Clinic and Laboratory, QEII Health Sciences Centre

Halifax, Nova Scotia, B3H2E2, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Malgorzata rajda

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: October 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)