Clinical trial NCT03250468: Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients
Official title: Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Cardiovascular Diseases
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Quality
timeFrame: Through study completion, up to 3 months
Secondary outcomes:
measure: Sleep Symptoms
timeFrame: Through study completion, up to 3 months
measure: Sleepiness
timeFrame: Through study completion, up to 3 months
measure: Activity
timeFrame: Through study completion, up to 3 months
measure: Mental Health
timeFrame: Through study completion, up to 3 months
measure: Quality of life
timeFrame: Through study completion, up to 3 months
measure: Cardiovascular Risk Factors
timeFrame: Through study completion, up to 3 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Clinical, Health, and Rehabilitation Psychologist
name: Heather Tulloch, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: