Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia in Rural Adults

CER-2018C2-13262

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 1200 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.

2022-02-25

2024-05-01

2024-05-01

Active (not recruiting)

Early phase I

1200

Inclusion Criteria: * Age 18-80 * Insomnia Severity Index score \> 10 * Regular internet and computer access * Receives primary care in a Non-metropolitan/Rural residence Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized (1:1:1) comparative effectiveness trial of medication preference (zolpidem or trazodone), CBT-I, and the combination for the treatment of insomnia in 1200 men and women aged 18-80 years living in rural areas.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Masking of participants and providers is not possible given two very different treatment types. The Prime Principal Investigator and a statistician at the Data Coordinating Center will be masked to individual treatment assignment.', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}

2023-06-05