Clinical trial NCT01648049: Treatment of Insomnia and Depression in Elders (TIDE)
Official title: Treatment of Insomnia and Depression in Elders (TIDE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Insomnia
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-07-24
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 3-month follow-up (23weeks post-treatment)
measure: Hamilton Depression Scale
timeFrame: 10 weeks Post-treatment
measure: Hamilton Depression Scale
timeFrame: 3 Month follow-up (23 weeks post treatment)
measure: Insomnia Severity Index
timeFrame: 10 weeks Post-treatment
Secondary outcomes:
measure: GDS
timeFrame: Pre-Treatment (Baseline/Week 0)
measure: SOL
timeFrame: Pre-Treatment (Baseline/Week 0)
measure: WASO
timeFrame: Pre-Treatment (Baseline/Week 0)
measure: SOL
timeFrame: 10 weeks Post-treatment
measure: SOL
timeFrame: 3-month follow-up (23weeks post-treatment)
measure: GDS
timeFrame: 10 weeks Post-treatment
measure: GDS
timeFrame: 3-month follow-up (23weeks post-treatment)
measure: WASO
timeFrame: 10 weeks Post-treatment
measure: WASO
timeFrame: 3-month follow-up (23weeks post-treatment)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: UATuscaloosa
state: Alabama
Study officials:
affiliation: University of Alabama, Tuscaloosa
name: Kenneth L. Lichstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama, Tuscaloosa
name: Forrest Scogin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: