Researching Effective Sleep Treatments (Project REST)

Completed · Not applicable

Conditions studied: Insomnia

In brief

We will undertake initial development of a new behavioral sleep intervention (i.e., partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold standard treatment, CBT-I. We will examine if the new treatment has a positive impact on subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and broader psychiatric functioning.

Key facts

Study ID

NCT02120989

Run by

University of California, San Diego

People needed

8

Starts

2014-05-01

Expected to finish

2015-02-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Meet diagnostic criteria for insomnia, including a score of 8 or higher on the Insomnia Severity Index (ISI)
• Stable bed partner (i.e., someone with whom they have lived for at least one month prior to the screening appointment and someone who they anticipate to continue living with for the next two months while in the study treatment) who can commit to participating in patient's insomnia treatment. Patients and bed partners who sleep in different beds are eligible to participate.
• English literacy
• Participation in the group Partner-Assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) class

You may not qualify if…

• A score of 7 or lower on the Insomnia Severity Index (ISI)
• Unmanaged psychosis or manic episodes in the past two months. For any interested potential participants with a history of bipolar disorder, their bipolar disorder must be stable (i.e., euthymic) for two months in order to be eligible to participate.
• Diagnosed (previously or by our study screen) and untreated sleep disorder other than insomnia. Sleep disorders diagnosed, but stably treated (e.g., obstructive sleep apnea treated with CPAP) will be allowed, as long as the treatment is not a hypnotic medication.
• Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
• Current substance use disorder, or meeting criteria for a SUD within the last 90 days

Where it is running

• VA San Diego Healthcare System — San Diego, California, United States

Full record on ClinicalTrials.gov

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