Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
8 participants
INTERVENTIONAL
2014-05-31
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Partner-Assisted Cognitive Behavioral Therapy for Insomnia
Study treatment includes partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) and consists of 7-8 weekly group therapy sessions of 2 hours each. Partner-assisted CBT-I focuses on altering patients' sleep schedules and changing their behaviors and patterns around sleeping in order to help them sleep in a single block of time overnight. As part of this treatment, participants will be asked to change, possibly reduce, the amount of time spent in bed and to maintain a specific bed time and wake time, as well as other potential changes depending on his/her specific insomnia pattern. This treatment has been shown to be safe and efficacious for a wide range of patients.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Veterans Medical Research Foundation
OTHER
San Diego Veterans Healthcare System
FED
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sean P.A. Drummond
Associate Professor of Psychiatry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sean PA Drummond, PhD
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System and University of California San Diego
Melissa M Jenkins, PhD
Role: STUDY_DIRECTOR
VA San Diego Healthcare System and University of California San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA San Diego Healthcare System
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5.
Perlis, M.L., et al., Cognitive-behavioral therapy for insomnia, in Clinical Handbook of Insomnia. 2004, Springer. p. 155-171.
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
Spanier, G.B., Measuring Dyadic Adjustment: New Scales for Assessing the Quality of Marriage and Similar Dyads. Journal of Marriage and Family, 1976. 38(1): p. 15-28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H140059
Identifier Type: -
Identifier Source: org_study_id