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

Research aims:

1. To determine if participation in a group-based cognitive behavioural therapy intervention (CBT-I) intervention results in improved sleep quality.
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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Insomnia
• Intervention / Treatment: Behavioral: CBT-I

Detailed Description

Cardiovascular disease affects 5% of the population and almost 20% of those meet the criteria for insomnia; twice as many as in the general population. Patients with cardiovascular disease and insomnia have been found to have elevated rates of anxiety and depression, which in turn places individuals at further cardiovascular risk via physiological pathways like increased blood pressure and/or vascular inflammation. Further, insomnia has been linked with negative health outcomes that exacerbate risk, including obesity, hypertension, and future acute myocardial infarction. Given the negative impact of poor sleep on cardiac health, some have argued that insomnia should now be included in the top 10 modifiable risk factors for cardiovascular disease.

Currently the best treatment for insomnia is a group-based cognitive behavioural therapy intervention (CBT-I); this intervention is more effective than pharmacotherapy. Evidence shows that CBT-I produces significant improvements after 6 weeks of intervention and improvements continue over the long term. This intervention program includes specific cognitive therapy exercises aimed at maladaptive thoughts about sleep, behaviour change techniques, and relaxation strategies (e.g., mindfulness, deep breathing); it also provides a supportive environment for individuals to discuss their sleep difficulties, allowing them to feel normalized and less isolated. For most people with insomnia however, their disorder goes untreated, leaving individuals at higher risk for affective disorders (e.g., depression), cardiovascular disease, and poorer quality of life. This lack of treatment is widespread and systemic; patients who want help with insomnia face a dearth of information about treatment, actual access to treatment and affordable services.

The proposed study is the first evaluation of a comprehensive CBT-I intervention designed for cardiac patients. Of note, the proposed study will be the first to evaluate the impact of this intervention on cardiovascular outcomes.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-I; 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; 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.
No Intervention: Wait-list control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Sleep quality will be measured using the Consensus Sleep Diary.	Through study completion, up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Symptoms	Sleep symptoms will be measured using the Insomnia Severity Index	Through study completion, up to 3 months
Sleepiness	The widely used Epworth Sleepiness Scale will be used to measure levels of sleepiness .experienced by patients	Through study completion, up to 3 months
Activity	Participants will wear an ActiGraph GTX3 accelerometer (ActiGraph, Pensacola, Florida) to assess sleep and physical activity	Through study completion, up to 3 months
Mental Health	Both symptoms and severity of anxiety and depression will be measured	Through study completion, up to 3 months
Quality of life	Patient quality of life will be measured using the 36-item short-form health survey (SF-36; version 1)	Through study completion, up to 3 months
Cardiovascular Risk Factors	Cardiovascular disease diagnosis, fasting blood glucose concentration, triglycerides, glycated hemoglobin (HbA1c), cholesterol (High-density lipoprotein ratio	Through study completion, up to 3 months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Heather Tulloch, Ph.D, Clinical, Health, and Rehabilitation Psychologist

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Cardiovascular Diseases; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 6997 (Duke legacy protocol number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No