Researching Effective Sleep Treatments (Project REST)

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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