Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Insomnia
• Intervention / Treatment: Behavioral: Integrated Cognitive Behavioral Therapy (CBT); Behavioral: Treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35487
      • UATuscaloosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT; Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.	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).
Active Comparator: Treatment as Usual; No additional treatment besides regular care.	Behavioral: Treatment as usual; Standard Care - Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	Insomnia Measure	3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale	Depression measure	10 weeks Post-treatment
Hamilton Depression Scale	Depression Measure	3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index	Insomnia Measure	10 weeks Post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GDS	Self-reported Geriatric Depression Scale	Pre-Treatment (Baseline/Week 0)
SOL	self-reported Sleep Onset Latency	Pre-Treatment (Baseline/Week 0)
WASO	Wake-time After Sleep Onset	Pre-Treatment (Baseline/Week 0)
SOL	Self-reported Sleep onset latency	10 weeks Post-treatment
SOL	Self-reported Sleep onset latency	3-month follow-up (23weeks post-treatment)
GDS	Self Reported Geriatric Depression Scale	10 weeks Post-treatment
GDS	Self-reported Geriatric Depression Scale	3-month follow-up (23weeks post-treatment)
WASO	Wake-time After Sleep Onset	10 weeks Post-treatment
WASO	Wake-time After Sleep Onset	3-month follow-up (23weeks post-treatment)

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa; Principal Investigator: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 10-0309; 1R34MH086643-01A2 (U.S. NIH Grant/Contract)