A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

Mental Disorders Clinical Trial

Official title:

A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469233
• Other study ID #: R01MH105513
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 17, 2019

Study information

• Verified date: December 2019
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to determine if an intervention to improve sleep can improve functioning and reduce symptoms and impairment. We will conduct this study in community mental health centers to ensure that the results contribute to closing the worrisome gap between research and practice and to ensure that the findings are generalizable to the real world.

Description:

Despite advances in treatment, severe mental illness (SMI) remains common, chronic and difficult to treat. SMI is defined as having at least one mental disorder that lasts for 12-months and leads to substantial life interference. Sleep and circadian dysfunctions are among the most prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced by people with SMI. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused—they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real life sleep and circadian problems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, we aim to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. We will recruit participants across DSM diagnoses and across common sleep and circadian problems. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in community settings with community-based providers. Accordingly, we propose to conduct an 'efficacy in the real world' randomized controlled trial within Alameda County Behavioral Health Care Services (ACBHCS), the community mental health center (CMHC) for Alameda County. We will recruit 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS. Individuals will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before, immediately following treatment (ie. 9-14 weeks later) and again 6 months later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18+ years

• English language fluency

• Presence of at least one DSM-V mental disorder for 12 months

• One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview:

• =30 mins to get to sleep , 3 or more nights per week

• Waking in the middle of the night for =30 minutes, 3 or more nights per week

• Obtaining less than 6 hours of sleep per night, 3 or more nights per week

• Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week

• More than 2.78 hours of variability in sleep-wake schedule across one week

• Bedtime later than 2 am, 3 or more nights per week

• Guaranteed bed to sleep in for the duration of the treatment phase

• Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager

Exclusion Criteria:

• Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible.

• Current serious suicide risk (assessed by our staff, a case manager or psychiatrist) or homicide risk (assessed by our staff, a case manager or psychiatrist)

• Night shift work >2 nights per week in the past 3 months

• Pregnancy or breast-feeding

• Not able/willing to participate in and/or complete the pre-treatment assessments

Related Conditions & MeSH terms

• Mental Disorders

Intervention

Behavioral:
• Transdiagnostic Intervention for Sleep and Circadian Dysfunction
The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.

Locations

Country	Name	City	State
United States	Alameda Country Behavioral Health Care Services	Oakland	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Berkeley	Alameda County Behavioral Health Care Services, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )		Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
Other	Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)		Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other	Sleep and Circadian Problems Interview		Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other	Insomnia Severity Index		Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other	Hypersomnia Severity Index		Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other	Therapy Process Measure	Credibility Expectancy Questionnaire	Administered at the end of Session 2 of treatment
Other	Medication and Other Treatment Tracking form		Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other	Additional screen for sleep apnea	STOP BANG Questionnaire	Baseline Only
Other	Brief Pain Inventory (Short Form)	Current symptoms of chronic pain	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Other	Clinic Staff Qualitative Assessment	Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting	One time at the convenience of clinic staff
Other	Client Behavior Change Interview	Exploration of barriers and facilitators to behavior change	One time following the completion of the first post-treatment assessment
Other	Salivary Cytokine Assay	Measure of cytokines present in saliva (e.g., IL-1 beta, IL-6, IL-8, TNF alpha, and/or CRP) to assess immune function	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Other	Credibility Evaluation Questionnaire (CEQ)	Client evaluation of treatment	Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
Other	Patient Recall Task	Participant recall of sleep coaching treatment	Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
Other	Patient Learning Task (Application and Thoughts subsections)	Client feedback and application of treatment	Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Other	Useful and Utilized Questionnaire	Measure of sleep coaching elements used/useful to clients	Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Other	Treatment Adherence Rating Scale-Therapist Version	Therapist evaluation of client adherence to treatment	After each treatment session filled out by therapist (8 times)
Other	Body weight	To calculate BMI	Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Other	Height	To calculate BMI	Pre-treatment
Primary	Impairment (Sheehan Disability Scale)	Sheehan Disability Scale (sleep)	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Primary	Disorder-Focused Composite Score (DSM-5)	DSM-5 Cross Cutting Measure	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Primary	Sleep and Circadian Function	PROMIS-Sleep Disturbance and PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Depression (QIDS)	QIDS (Quick Inventory of Depressive Symptoms)	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Substance use (ASSIST )	ASSIST (Alcohol, Smoking and Substance Involvement Screening Test)	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Psychotic symptoms (PSYRATS )	PSYRATS (Psychotic Symptom Rating Scales)	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Means and Variability of sleep efficiency (Daily Sleep Diary)	Daily Sleep Diary means and variability for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime.	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Actigraphy Measured Sleep	Actigraphy: Means and variability for Total sleep time (TST), Total wake time (TWT)	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Daytime Activity (Actigraphy)	Actigraphy Measured Daytime Activity Count	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Impairment (World Health Organization Disability Assessment Schedule 2.0)		Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Overall Health ('Healthy Days' core module)	Four question 'healthy days' core module developed by the CDC	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Secondary	Composite Sleep Health Score	Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation across the 7 day sleep diary), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint across the 7 day sleep diary), Efficiency (Sleep efficiency based on the 7 day sleep diary) and Duration (Total Sleep Time based on 7 day sleep diary).	Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6- month followupt