- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01648049
Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Alabama
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Tuscaloosa, Alabama, Verenigde Staten, 35487
- UATuscaloosa
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
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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).
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Actieve vergelijker: Treatment as Usual
No additional treatment besides regular care.
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Standard Care - Treatment as usual
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Insomnia Severity Index
Tijdsspanne: 3-month follow-up (23weeks post-treatment)
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Insomnia Measure
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3-month follow-up (23weeks post-treatment)
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Hamilton Depression Scale
Tijdsspanne: 10 weeks Post-treatment
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Depression measure
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10 weeks Post-treatment
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Hamilton Depression Scale
Tijdsspanne: 3 Month follow-up (23 weeks post treatment)
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Depression Measure
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3 Month follow-up (23 weeks post treatment)
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Insomnia Severity Index
Tijdsspanne: 10 weeks Post-treatment
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Insomnia Measure
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10 weeks Post-treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
GDS
Tijdsspanne: Pre-Treatment (Baseline/Week 0)
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Self-reported Geriatric Depression Scale
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Pre-Treatment (Baseline/Week 0)
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SOL
Tijdsspanne: Pre-Treatment (Baseline/Week 0)
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self-reported Sleep Onset Latency
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Pre-Treatment (Baseline/Week 0)
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WASO
Tijdsspanne: Pre-Treatment (Baseline/Week 0)
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Wake-time After Sleep Onset
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Pre-Treatment (Baseline/Week 0)
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SOL
Tijdsspanne: 10 weeks Post-treatment
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Self-reported Sleep onset latency
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10 weeks Post-treatment
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SOL
Tijdsspanne: 3-month follow-up (23weeks post-treatment)
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Self-reported Sleep onset latency
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3-month follow-up (23weeks post-treatment)
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GDS
Tijdsspanne: 10 weeks Post-treatment
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Self Reported Geriatric Depression Scale
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10 weeks Post-treatment
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GDS
Tijdsspanne: 3-month follow-up (23weeks post-treatment)
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Self-reported Geriatric Depression Scale
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3-month follow-up (23weeks post-treatment)
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WASO
Tijdsspanne: 10 weeks Post-treatment
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Wake-time After Sleep Onset
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10 weeks Post-treatment
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WASO
Tijdsspanne: 3-month follow-up (23weeks post-treatment)
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Wake-time After Sleep Onset
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3-month follow-up (23weeks post-treatment)
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa
- Hoofdonderzoeker: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10-0309
- 1R34MH086643-01A2 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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