Researching Effective Sleep Treatments (Project REST) — REST  

Insomnia Clinical Trial

Official title: A Pilot Study Examining the Effectiveness of Partner-Assisted Cognitive Behavioral Therapy for Insomnia

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Objective: To investigate whether partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) has a positive impact on subjective and objective sleep and quality of life in individuals with insomnia. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and impact on broader psychiatric functioning.

Research Design: This is an open trial, feasibility study designed to examine the effectiveness of partner-assisted CBT-I on insomnia patient's sleep and quality of life. After individuals, Veterans and non-Veterans, and their respective bed partners consent to participate in this treatment study, we will collect de-identified data including self-report questionnaires, daily sleep diaries, and actigraphy (ambulatory sleep/wake monitoring). For Veteran participants, we also plan to collect data from medical records. Study participants will be seen for study partner-assisted CBT-I treatment at the VA San Diego Healthcare System (VASDHS) Sleep and Mood Clinic. The initial screening appointment and 1-month follow up assessment will be conducted in the Veterans Medical Research Foundation (VMRF) building. The entire study will take two years; participation for Veterans and non-Veterans will last about 3 months from the date of initial screening appointment to their follow up assessment.

Methodology:

Procedures:

Participants will primarily be recruited through the VASDHS's Sleep and Mood Clinic by physician and clinician referrals as well as posted study fliers in these clinics. Non-veterans such as those enrolled in other UCSD research studies will also be recruited. All individuals who meet eligibility criteria will be offered the opportunity to participate and informed consent will be obtained for those who wish to do so. Participation or non-participation in the protocol will not affect clinical care. Assessments of sleep symptoms, health-related quality of life, treatment adherence, relationship satisfaction, and psychiatric functioning will occur as part of standard treatment protocols. Assessments include self-report questionnaires as well as weekly sleep diaries and two weeks of actigraphy (e.g., at the start and end of treatment). Assessment data will be de-identified and analyzed to determine: (a) descriptive characteristics of study participants; (b) effectiveness of partner-assisted CBT-I treatment; (c) relationship functioning; (d) treatment adherence (e.g., did participants follow treatment recommendations from week to week); and, (e) any reduction in symptoms of psychiatric conditions that frequently co-occur with insomnia including mood and/or PTSD symptoms.

Treatment:

We aim to test the effectiveness of partner-assisted CBT-I treatment in patients with insomnia. There are currently no published studies on a couple-based CBT-I approach. The proposed treatment will closely resemble the CBT-I manual currently used for insomnia group therapy in the VA Sleep and Mood Clinic. The main difference will be the inclusion of patients' partners in treatment and administering the manual with emphasis on how patients' partners can assist the patient in making behavioral changes outlined and prioritized in the existing manual.

Data Extraction and Security Plan:

Data will be collected and extracted in a de-identified format and coded only with a study specific number.

• Demographic information: e.g., age, relationship status, era of military service (for Veteran participants), gender, race and ethnicity.

• Treatment information: e.g., number of sessions attended, treatment adherence, treatment barriers.

• Medical / Psychiatric Information: e.g., history of treatment for psychiatric co-morbidities, use of pharmacological agents, and presence of medical conditions.

Statistical Procedures:

• Prior to quantitative analyses, data will be screened to ensure quality and to check standard statistical assumptions.

• Descriptive Statistics will be used to calculate frequency of demographic variables in patients.

• Paired sample t-tests will examine change in pre-treatment and post-treatment means for sleep, quality of life and relationship satisfaction variables.

• Paired sample t-tests will also examine change in post-treatment and follow-up means for sleep, quality of life and relationship satisfaction variables.

• Descriptive Statistics will calculate average weekly treatment adherence from the participant, partner and the therapist perspectives. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

• NCT number: NCT02120989
• Study type: Interventional
• Source: University of California, San Diego
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: February 2015