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

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ClinicalTrials.gov Identifier: NCT01648049
Recruitment Status : Unknown
Verified November 2015 by University of Alabama, Tuscaloosa.
Recruitment status was:  Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression Insomnia Behavioral: Integrated Cognitive Behavioral Therapy (CBT) Behavioral: Treatment as usual

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Insomnia and Depression in Elders (TIDE)
Study Start Date : June 2012
Primary Completion Date : March 2015
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: 3-month follow-up (23weeks post-treatment) ]
    Insomnia Measure

  2. Hamilton Depression Scale [ Time Frame: 10 weeks Post-treatment ]
    Depression measure

  3. Hamilton Depression Scale [ Time Frame: 3 Month follow-up (23 weeks post treatment) ]
    Depression Measure

  4. Insomnia Severity Index [ Time Frame: 10 weeks Post-treatment ]
    Insomnia Measure

Secondary Outcome Measures :
  1. GDS [ Time Frame: Pre-Treatment (Baseline/Week 0) ]
    Self-reported Geriatric Depression Scale

  2. SOL [ Time Frame: Pre-Treatment (Baseline/Week 0) ]
    self-reported Sleep Onset Latency

  3. WASO [ Time Frame: Pre-Treatment (Baseline/Week 0) ]
    Wake-time After Sleep Onset

  4. SOL [ Time Frame: 10 weeks Post-treatment ]
    Self-reported Sleep onset latency

  5. SOL [ Time Frame: 3-month follow-up (23weeks post-treatment) ]
    Self-reported Sleep onset latency

  6. GDS [ Time Frame: 10 weeks Post-treatment ]
    Self Reported Geriatric Depression Scale

  7. GDS [ Time Frame: 3-month follow-up (23weeks post-treatment) ]
    Self-reported Geriatric Depression Scale

  8. WASO [ Time Frame: 10 weeks Post-treatment ]
    Wake-time After Sleep Onset

  9. WASO [ Time Frame: 3-month follow-up (23weeks post-treatment) ]
    Wake-time After Sleep Onset

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648049

United States, Alabama
Tuscaloosa, Alabama, United States, 35487
Sponsors and Collaborators
University of Alabama, Tuscaloosa
National Institute of Mental Health (NIMH)
Principal Investigator: Kenneth L. Lichstein, Ph.D. University of Alabama, Tuscaloosa
Principal Investigator: Forrest Scogin, Ph.D. University of Alabama, Tuscaloosa
More Information

Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT01648049     History of Changes
Other Study ID Numbers: 10-0309
1R34MH086643-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases