CBT-I or Zolpidem/Trazodone for Insomnia
- Conditions
- Chronic Insomnia
- Interventions
- Registration Number
- NCT04468776
- Brief Summary
This study is a randomized (1:1:1) comparative effectiveness trial of medication (zolpidem or trazodone), cognitive-behavioral therapy for insomnia (CBT-I), and the combination (medication + CBT-I) for the treatment of chronic insomnia in men and women aged 18-80 living in rural areas with 1 year of follow-up. A total of 155 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.
- Detailed Description
Insomnia is a common health problem that causes distress, impaired function, and increased risk for other health problems. Chronic insomnia is defined by problems with the quality or amount of sleep, including difficulty falling asleep, frequent awakenings, and/or awakening early and being unable to return to sleep. In developing this application, patients, providers, payors, and the investigators identified both concerns and opportunities with current treatments for chronic insomnia. Medications and Cognitive-Behavioral therapy for insomnia (CBT-I; a treatment program to improve sleep through changes in behavior and thinking) are both effective for treating insomnia. Zolpidem, the most frequently prescribed insomnia medication, is widely available, but may cause side effects and dependency. Trazodone is increasingly prescribed off-label for treatment of insomnia, but evidence of efficacy and safety is more limited. CBT-I is the recommended first line treatment by many professional organizations, but it is not widely available in physicians' practices. Patients, providers, and payors face important unanswered questions: Which treatment should be used for the treatment of chronic insomnia? Is combination therapy more effective, and does it result in lower zolpidem use? Who responds best to which treatment? These dilemmas are particularly relevant to patients and providers in rural areas, where access to behavioral health specialists is limited, and concerns regarding use of controlled substances is particularly acute.
To address these questions, we propose the study, Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia in Rural Adults (COZI). The investigators will use a well-tested Internet version of CBT-I, which is just as effective as in-person CBT-I, but more widely available. The aims of COZI are to: 1: Compare the effectiveness of medication preference (zolpidem or trazodone), CBT-I, and combination treatment for insomnia symptoms over 6 months. 2: Compare the effectiveness of medication preference, CBT-I, and combination treatment for other symptoms and problems, including health-related quality of life, mood, and health outcomes. 3: Compare the side effects of medication preference, CBT-I, and combination treatment. COZI will study 155 patients recruited from 7 health care systems across the country, each of which has established practices in rural areas. Patients will be treated with medication prescribed by their own physician (zolpidem or trazodone), Internet CBT-I, or a combination of the two. The investigators will evaluate treatment effects at 9 weeks, and 6 and 12 months (with limited additional assessments for adverse events and medication use at 1 and 9 months). Our study questions and design reflect early and ongoing engagement of key stakeholders including patients, providers, and payors, who are members of the Study Advisory Committee (SAC). SAC members will work with study investigators to recommend the best strategies for recruiting patients, measuring treatment effects, and disseminating study findings. The SAC will meet quarterly. Patients and other stakeholders have already provided guidance on which treatments are most worth studying, and which symptoms would best reflect the effects of treatment. Patients and other stakeholders will also be part of the Steering Committee, which is the main decision-making group for our study, and which will meet monthly. COZI will lead to answers for patients and providers addressing insomnia; improved health and function for millions of rural Americans; and sustainable changes in how insomnia is treated in rural practices.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- Age 18-80
- Insomnia Severity Index score > 10
- Regular internet and computer access
- Receives primary care in a Non-metropolitan/Rural residence
- Use of hypnotic medication >2 times in the past week
- Current cognitive or cognitive behavioral treatment for insomnia
- Psychotic disorder
- Bipolar disorder
- Current substance use disorder
- Severe Chronic obstructive pulmonary disease (COPD) or other severe pulmonary disease (such as asthma or lung fibrosis)
- Cognitive impairment or dementia
- History of spontaneous or hypnotic-induced complex sleep behavior
- Delayed sleep phase disorder (DSPD)
- Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
- History of fracture or injurious fall in the past 12 months
- Currently pregnant, planning to become pregnant, or breastfeeding
- Other severe or uncontrolled mental or physical disorders that would make participation difficult or unsafe
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) Internet-based CBT-I program Combination Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program Combination Zolpidem Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program Medication (zolpidem or trazodone) Zolpidem Zolpidem or trazodone, as prescribed by physician Medication (zolpidem or trazodone) Trazodone Zolpidem or trazodone, as prescribed by physician Combination Trazodone Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program
- Primary Outcome Measures
Name Time Method Change in Insomnia Symptom Severity Baseline, 6 months Change in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Baseline ISI, Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Response of Insomnia Symptoms Baseline, 6 months Treatment response defined as a ≥6 point reduction in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Data presented as count of participants meeting treatment response criteria at 6 months.
Number of Participants With Remission of Insomnia Symptoms 6 months Remission of Insomnia symptoms defined as Insomnia Severity Index \<8 at follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Data presented as count of participants meeting insomnia remission criteria at 6 months.
Trial Locations
- Locations (7)
University of Missouri
đŸ‡ºđŸ‡¸Columbia, Missouri, United States
Penn State Hershey Medical Center
đŸ‡ºđŸ‡¸Hershey, Pennsylvania, United States
University of Virginia
đŸ‡ºđŸ‡¸Charlottesville, Virginia, United States
Oregon Health & Science University
đŸ‡ºđŸ‡¸Portland, Oregon, United States
University of Alabama at Birmingham
đŸ‡ºđŸ‡¸Birmingham, Alabama, United States
University of Pittsburgh
đŸ‡ºđŸ‡¸Pittsburgh, Pennsylvania, United States
University of Arizona
đŸ‡ºđŸ‡¸Tucson, Arizona, United States