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This is a pilot trial to test the feasibility and acceptability of a virtual cognitive behavioral program for insomnia for patients with cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral: Intervention - Adapted Virtual Insomnia Program | Experimental | 4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences of patients with cirrhosis. Interventionists will participate in weekly supervision. Participants will be asked to complete sleep diaries and wear sleep trackers for one-week prior to starting the intervention and one-week after completing the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Virtual Insomnia Program | Behavioral | 4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences of patients with cirrhosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Enrollment rate of those screened and eligible | Percent of those screened and eligible who enroll (i.e., sign consent and complete baseline). Reasons for ineligibility, refusal, or drop out, will also be measured along with session attendance. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction | Participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the program in exit interviews, which will use open-ended questions and response probes to explicate each rating | Baseline to Week 8 (4 weeks post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Quality | Change in sleep quality will be assessed using the validated Pittsburgh Sleep Quality Index. | Baseline up to Week 8 (1 month post-intervention) |
| Change in Anxiety and Depression Symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Munroe | Contact | 617-726-0161 | Wlmunroe@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| Change in Insomnia Severity | Change in insomnia severity will be assessed using the validated Insomnia Severity Index (ISI). Scores of 8 or higher on the ISI indicate clinically significant insomnia. | Baseline up to Week 8 |
Change in anxiety and depression symptoms will be assessed using the validated Hospital Anxiety and Depression Scale. Score range 0-21 with higher scores indicating higher psychological distress.
| Baseline up to Week 8 (1 month post-intervention) |
| Change in Pain Severity | Change in pain severity will be assessed using the validated Brief Pain Index | Baseline up to Week 8 (1 month post-intervention) |
| Change in Symptom Burden | Change in symptom burden will be assessed using the validated Edmonton Symptom Assessment System | Baseline up to Week 8 (1 month post-intervention) |
| Change in Cognitive Function | Change in cognitive function will be assessed using the validated Simplified Animal Naming Test | Baseline up to Week 8 (1 month post-intervention) |
| Change in health-related quality of life | Change in health-related quality of life, including fatigue, will be assessed using the validated PROMIS-29+2 scale | Baseline up to Week 8 (1 month post-intervention) |
| Change in nightly subjective sleep and covariance with objective sleep | Subjective Sleep: Measured via sleep diary. Total sleep time, sleep latency, sleep efficiency, and wake after sleep onset will be assessed using a sleep diary (i.e., timings of sleep/wake, timings of being in bed) for 1-2 weeks to achieve 7 consecutive days of sleep reporting at each timepoint. | Baseline up to Week 8 (1 month post-intervention) |
| Change in nightly objective sleep and covariance with subjective sleep | Objective Sleep: Measured via actigraphy data collection. During the same time period as participants complete the sleep diary, objective sleep will be assessed using actigraphy devices to calculate: total sleep time, sleep latency, sleep efficiency, wake after sleep onset, and a Mean Activity Score (actigraph counts/min) | Baseline up to Week 8 (1 month post-intervention) |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |