Researching Effective Sleep Treatments (Project REST)

NCT02120989 | Completed

• 1 other identifier: H140059
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Keywords

insomnia; cognitive behavioral therapy for insomnia (CBT-I); partner-assisted

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Functioning from Baseline to the End of Treatment

  Primary outcome measures (see below for more information about the measures) will assess the change in sleep functioning from baseline to the end of treatment. We will also examine change in sleep functioning from baseline to the 1-month post treatment assessment. Sleep diaries. Participants will be asked to complete a daily sleep diary throughout the 8 week treatment and one week prior to the 1 month post-treatment follow up appointment. Each morning participants are asked to record sleep habits, such as bedtime, wake time, time in bed, and number and duration of awakenings. Our sleep diary will include questions to track treatment adherence. Sleep diaries are widely used in studies of insomnia. Questionnaire. Insomnia Severity Index (ISI; Morin et al., 2011). The ISI consists of 7-items that assess severity of insomnia, satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties in the past week.

  baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up

Secondary Outcomes (2)

• Change in Quality of Life from Baseline to the End of Treatment

  baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up

• Change in Relationship Functioning from Baseline to the End of Treatment

  baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up

Interventions

Partner-Assisted Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Veterans Medical Research Foundation: collaborator
• San Diego Veterans Healthcare System: collaborator

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (6)

• 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.

  PMID: 8037252 BACKGROUND

• 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.

  PMID: 11772681 BACKGROUND

• Perlis, M.L., et al., Cognitive-behavioral therapy for insomnia, in Clinical Handbook of Insomnia. 2004, Springer. p. 155-171.

  BACKGROUND

• 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.

  PMID: 21532953 BACKGROUND

• 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.

  PMID: 8290681 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sean PA Drummond, PhD

  VA San Diego Healthcare System and University of California San Diego

  PRINCIPAL INVESTIGATOR

• Melissa M Jenkins, PhD

  VA San Diego Healthcare System and University of California San Diego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 23, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

US (1)