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

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Integrated Cognitive Behavioral Therapy (CBT)

Behavioral:Treatment as usualStandard Care - Treatment as usual

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Treatment as UsualNo additional treatment besides regular care.

Study Status

Active, not recruiting

Start Date: June 2012

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Insomnia Severity Index

Secondary Outcome: GDS

Study sponsors, principal investigator, and references

Principal Investigator: Kenneth L. Lichstein, Ph.D.

Lead Sponsor: University of Alabama, Tuscaloosa

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT01648049

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