Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients

NCT03250468 | Terminated

• 1 other identifier: 6997
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Research aims:

1. 1.To determine if participation in a group-based cognitive behavioural therapy intervention (CBT-I) intervention results in improved sleep quality.
2. 2.To determine if participation in a group-based CBT-I intervention results in improved cardiovascular disease risk factors, and if the CBT-I intervention moderates that relationship.

Conditions

Insomnia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  Sleep quality will be measured using the Consensus Sleep Diary.

  Through study completion, up to 3 months

Secondary Outcomes (6)

• Sleep Symptoms

  Through study completion, up to 3 months

• Sleepiness

  Through study completion, up to 3 months

• Activity

  Through study completion, up to 3 months

• Mental Health

  Through study completion, up to 3 months

• Quality of life

  Through study completion, up to 3 months

Study Arms (2)

CBT-I

EXPERIMENTAL

Participants randomized to receive the intervention will attend 6 weekly group-based CBT-I sessions. Each 90-minute group will include 6-12 participants.

Behavioral: CBT-I

Wait-list control

NO INTERVENTION

The wait-list control group will receive treatment as per our standard cardiac rehabilitation program. After completion of the 3-month follow-up questionnaire, wait-list control participants may take part in the intervention.

Interventions

CBT-I BEHAVIORAL

Each weekly session will focus on several psychological and behavioural techniques that include sleep restriction, relaxation strategies, cognitive therapy, stimulus control therapy, and education about proper sleep hygiene.

CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sleep disturbance as indicated by a score on the Insomnia Severity Index (ISI) of 8 or above.
• Enrolled in the cardiac rehabilitation program offered by the University of Ottawa Heart Institute.
• Willing to be randomized.
• Willing to wear a monitor that tracks sleep and physical activity.

You may not qualify if:

• Untreated or undiagnosed obstructive sleep apnea (as per standard cardiac rehabilitation intake assessment, patients with a score of 5 or above on the STOP-BANG (a brief assessment for sleep apnea) will be referred for a sleep assessment by a cardiac rehabilitation physician).
• Unable to converse in English (i.e., while patient materials and questionnaires will be offered in both English and French, the intervention is only offered in English).
• Unable to provide written, informed consent.
• Unable to attend 6 weeks of onsite CBT-I intervention.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Heather Tulloch, Ph.D

  Clinical, Health, and Rehabilitation Psychologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 15, 2017
• Study Start: April 19, 2018
• Primary Completion: February 28, 2020
• Study Completion: March 2, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

CA (1)