Treatment of Insomnia and Depression in Elders (TIDE)

Depression Clinical Trial

— TIDE  

Official title:

Treatment of Insomnia and Depression in Elders (TIDE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01648049
• Other study ID #: 10-0309
• Secondary ID: 1R34MH086643-01A
• Status: Active, not recruiting
• Phase: N/A
• First received: June 26, 2012
• Last updated: November 30, 2015
• Start date: June 2012

Study information

• Verified date: November 2015
• Source: University of Alabama, Tuscaloosa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Insomnia and depression are two of the most prevalent mental health disorders and often co-occur.

Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources.

The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• 50 years of age or older,

• resident of the Black Belt or adjacent counties and receiving services from one of our primary care collaborators

• absence of significant cognitive impairment as indicated by a score of 24 or higher (17 or higher for those with only an eighth grade education) on the Mini-Mental Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975

• not currently receiving psychological treatment,

• absence of serious suicidality

• concurrent psychiatric/medical disorders are not automatic disqualifiers unless they prevent participants from attending CBT therapy sessions or impede data collection,

• a referral from their primary care physician indicating presence of both insomnia and depression symptoms of sufficient significance to warrant initiation or continuance of primary care treatment for newly emergent or residual symptoms. Persons who are currently receiving pharmacotherapy for insomnia and/or depression must evidence residual symptoms of both disorders of sufficient magnitude to be evaluated as clinically significant and warranting further treatment by their primary care physician.

Exclusion Criteria:

• age is below 50

• not receiving services from one of our primary care collaborators

• significant cognitive impairment is present as indicated by a score of 23 or lower (16 or lower for those with only an eighth grade education) on the MMSE

• currently receiving psychological treatment

• presence of serious suicidality

• intrusive and unstable concurrent psychiatric/medical disorders

• primary care physician declines to refer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insomnia

Intervention

Behavioral:
• Integrated Cognitive Behavioral Therapy (CBT)
CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
• Treatment as usual
Standard Care - Treatment as usual

Locations

Country	Name	City	State
United States	UATuscaloosa	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index	Insomnia Measure	3-month follow-up (23weeks post-treatment)	No
Primary	Hamilton Depression Scale	Depression measure	10 weeks Post-treatment	No
Primary	Hamilton Depression Scale	Depression Measure	3 Month follow-up (23 weeks post treatment)	No
Primary	Insomnia Severity Index	Insomnia Measure	10 weeks Post-treatment	No
Secondary	GDS	Self-reported Geriatric Depression Scale	Pre-Treatment (Baseline/Week 0)	No
Secondary	SOL	self-reported Sleep Onset Latency	Pre-Treatment (Baseline/Week 0)	No
Secondary	WASO	Wake-time After Sleep Onset	Pre-Treatment (Baseline/Week 0)	No
Secondary	SOL	Self-reported Sleep onset latency	10 weeks Post-treatment	No
Secondary	SOL	Self-reported Sleep onset latency	3-month follow-up (23weeks post-treatment)	No
Secondary	GDS	Self Reported Geriatric Depression Scale	10 weeks Post-treatment	No
Secondary	GDS	Self-reported Geriatric Depression Scale	3-month follow-up (23weeks post-treatment)	No
Secondary	WASO	Wake-time After Sleep Onset	10 weeks Post-treatment	No
Secondary	WASO	Wake-time After Sleep Onset	3-month follow-up (23weeks post-treatment)	No