Treatment of Insomnia and Depression in Elders (TIDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Alabama, Tuscaloosa
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT01648049
First received: June 26, 2012
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Depression
Insomnia
Behavioral: Integrated Cognitive Behavioral Therapy (CBT)
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Insomnia and Depression in Elders (TIDE)

Further study details as provided by University of Alabama, Tuscaloosa:

Primary Outcome Measures:
  • Insomnia Severity Index [ Time Frame: 3-month follow-up (23weeks post-treatment) ] [ Designated as safety issue: No ]
    Insomnia Measure

  • Hamilton Depression Scale [ Time Frame: 10 weeks Post-treatment ] [ Designated as safety issue: No ]
    Depression measure

  • Hamilton Depression Scale [ Time Frame: 3 Month follow-up (23 weeks post treatment) ] [ Designated as safety issue: No ]
    Depression Measure

  • Insomnia Severity Index [ Time Frame: 10 weeks Post-treatment ] [ Designated as safety issue: No ]
    Insomnia Measure


Secondary Outcome Measures:
  • GDS [ Time Frame: Pre-Treatment (Baseline/Week 0) ] [ Designated as safety issue: No ]
    Self-reported Geriatric Depression Scale

  • SOL [ Time Frame: Pre-Treatment (Baseline/Week 0) ] [ Designated as safety issue: No ]
    self-reported Sleep Onset Latency

  • WASO [ Time Frame: Pre-Treatment (Baseline/Week 0) ] [ Designated as safety issue: No ]
    Wake-time After Sleep Onset

  • SOL [ Time Frame: 10 weeks Post-treatment ] [ Designated as safety issue: No ]
    Self-reported Sleep onset latency

  • SOL [ Time Frame: 3-month follow-up (23weeks post-treatment) ] [ Designated as safety issue: No ]
    Self-reproted Sleep onset latency

  • GDS [ Time Frame: 10 weeks Post-treatment ] [ Designated as safety issue: No ]
    Self Reproted Geriatric Depression Scale

  • GDS [ Time Frame: 3-month follow-up (23weeks post-treatment) ] [ Designated as safety issue: No ]
    Self-reported Geriatric Depression Scale

  • WASO [ Time Frame: 10 weeks Post-treatment ] [ Designated as safety issue: No ]
    Wake-time After Sleep Onset

  • WASO [ Time Frame: 3-month follow-up (23weeks post-treatment) ] [ Designated as safety issue: No ]
    Wake-time After Sleep Onset


Estimated Enrollment: 46
Study Start Date: June 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648049

Contacts
Contact: Kenneth L. Lichstein, Ph.D. 205 348-4962 lichstein@ua.edu

Locations
United States, Alabama
UATuscaloosa Recruiting
Tuscaloosa, Alabama, United States, 35487
Contact: Kenneth L Lichstein, Ph.D.    205-348-4962    Lichstein@ua.edu   
Contact: Forrest Scogin, Ph.D    205.348.1924    fscogin@as.ua.edu   
Principal Investigator: Kenneth Lichstein, Ph.D.         
Principal Investigator: Forrest Scogin, Ph.D.         
Sponsors and Collaborators
University of Alabama, Tuscaloosa
Investigators
Principal Investigator: Kenneth L. Lichstein, Ph.D. University of Alabama, Tuscaloosa
Principal Investigator: Forrest Scogin, Ph.D. University of Alabama, Tuscaloosa
  More Information

No publications provided

Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT01648049     History of Changes
Other Study ID Numbers: 10-0309, 1R34MH086643-01A2
Study First Received: June 26, 2012
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014