Treatment of Insomnia and Depression in Elders (TIDE)

NCT01648049 | Unknown DMC

• 2 other identifiers: 10-03091R34MH086643-01A2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Insomnia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• GDS

  Pre-Treatment (Baseline/Week 0)

• SOL

  Pre-Treatment (Baseline/Week 0)

• WASO

  Pre-Treatment (Baseline/Week 0)

• SOL

  10 weeks Post-treatment

• SOL

  3-month follow-up (23weeks post-treatment)

Study Arms (2)

CBT

EXPERIMENTAL

Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.

Behavioral: Integrated Cognitive Behavioral Therapy (CBT)

Treatment as Usual

ACTIVE COMPARATOR

No additional treatment besides regular care.

Behavioral: Treatment as usual

Interventions

Integrated Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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).

CBT

Treatment as usual BEHAVIORAL

Standard Care - Treatment as usual

Treatment as Usual

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UATuscaloosa

Tuscaloosa, Alabama, 35487, United States

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kenneth L. Lichstein, Ph.D.

  University of Alabama, Tuscaloosa

  PRINCIPAL INVESTIGATOR

• Forrest Scogin, Ph.D.

  University of Alabama, Tuscaloosa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 24, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)