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

Primary Purpose

Depression, Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Cognitive Behavioral Therapy (CBT)
Treatment as usual
Sponsored by
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UATuscaloosa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT

Treatment as Usual

Arm Description

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

No additional treatment besides regular care.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
Insomnia Measure
Hamilton Depression Scale
Depression measure
Hamilton Depression Scale
Depression Measure
Insomnia Severity Index
Insomnia Measure

Secondary Outcome Measures

GDS
Self-reported Geriatric Depression Scale
SOL
self-reported Sleep Onset Latency
WASO
Wake-time After Sleep Onset
SOL
Self-reported Sleep onset latency
SOL
Self-reported Sleep onset latency
GDS
Self Reported Geriatric Depression Scale
GDS
Self-reported Geriatric Depression Scale
WASO
Wake-time After Sleep Onset
WASO
Wake-time After Sleep Onset

Full Information

First Posted
June 26, 2012
Last Updated
November 30, 2015
Sponsor
University of Alabama, Tuscaloosa
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01648049
Brief Title
Treatment of Insomnia and Depression in Elders (TIDE)
Acronym
TIDE
Official Title
Treatment of Insomnia and Depression in Elders (TIDE)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
No additional treatment besides regular care.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Cognitive Behavioral Therapy (CBT)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Standard Care - Treatment as usual
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Insomnia Measure
Time Frame
3-month follow-up (23weeks post-treatment)
Title
Hamilton Depression Scale
Description
Depression measure
Time Frame
10 weeks Post-treatment
Title
Hamilton Depression Scale
Description
Depression Measure
Time Frame
3 Month follow-up (23 weeks post treatment)
Title
Insomnia Severity Index
Description
Insomnia Measure
Time Frame
10 weeks Post-treatment
Secondary Outcome Measure Information:
Title
GDS
Description
Self-reported Geriatric Depression Scale
Time Frame
Pre-Treatment (Baseline/Week 0)
Title
SOL
Description
self-reported Sleep Onset Latency
Time Frame
Pre-Treatment (Baseline/Week 0)
Title
WASO
Description
Wake-time After Sleep Onset
Time Frame
Pre-Treatment (Baseline/Week 0)
Title
SOL
Description
Self-reported Sleep onset latency
Time Frame
10 weeks Post-treatment
Title
SOL
Description
Self-reported Sleep onset latency
Time Frame
3-month follow-up (23weeks post-treatment)
Title
GDS
Description
Self Reported Geriatric Depression Scale
Time Frame
10 weeks Post-treatment
Title
GDS
Description
Self-reported Geriatric Depression Scale
Time Frame
3-month follow-up (23weeks post-treatment)
Title
WASO
Description
Wake-time After Sleep Onset
Time Frame
10 weeks Post-treatment
Title
WASO
Description
Wake-time After Sleep Onset
Time Frame
3-month follow-up (23weeks post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth L. Lichstein, Ph.D.
Organizational Affiliation
University of Alabama, Tuscaloosa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Forrest Scogin, Ph.D.
Organizational Affiliation
University of Alabama, Tuscaloosa
Official's Role
Principal Investigator
Facility Information:
Facility Name
UATuscaloosa
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States

12. IPD Sharing Statement

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Treatment of Insomnia and Depression in Elders (TIDE)

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