Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)
|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
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||Phase|
|Depression Insomnia||Behavioral: Integrated Cognitive Behavioral Therapy (CBT) Behavioral: Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Insomnia and Depression in Elders (TIDE)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2015|
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
- Insomnia Severity Index [ Time Frame: 3-month follow-up (23weeks post-treatment) ]Insomnia Measure
- Hamilton Depression Scale [ Time Frame: 10 weeks Post-treatment ]Depression measure
- Hamilton Depression Scale [ Time Frame: 3 Month follow-up (23 weeks post treatment) ]Depression Measure
- Insomnia Severity Index [ Time Frame: 10 weeks Post-treatment ]Insomnia Measure
- GDS [ Time Frame: Pre-Treatment (Baseline/Week 0) ]Self-reported Geriatric Depression Scale
- SOL [ Time Frame: Pre-Treatment (Baseline/Week 0) ]self-reported Sleep Onset Latency
- WASO [ Time Frame: Pre-Treatment (Baseline/Week 0) ]Wake-time After Sleep Onset
- SOL [ Time Frame: 10 weeks Post-treatment ]Self-reported Sleep onset latency
- SOL [ Time Frame: 3-month follow-up (23weeks post-treatment) ]Self-reported Sleep onset latency
- GDS [ Time Frame: 10 weeks Post-treatment ]Self Reported Geriatric Depression Scale
- GDS [ Time Frame: 3-month follow-up (23weeks post-treatment) ]Self-reported Geriatric Depression Scale
- WASO [ Time Frame: 10 weeks Post-treatment ]Wake-time After Sleep Onset
- WASO [ Time Frame: 3-month follow-up (23weeks post-treatment) ]Wake-time After Sleep Onset
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648049
|United States, Alabama|
|Tuscaloosa, Alabama, United States, 35487|
|Principal Investigator:||Kenneth L. Lichstein, Ph.D.||University of Alabama, Tuscaloosa|
|Principal Investigator:||Forrest Scogin, Ph.D.||University of Alabama, Tuscaloosa|