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

30 novembre 2015 aggiornato da: University of Alabama, Tuscaloosa

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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Anticipato)

46

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Alabama
      • Tuscaloosa, Alabama, Stati Uniti, 35487
        • UATuscaloosa

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
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).
Comparatore attivo: Treatment as Usual
No additional treatment besides regular care.
Standard Care - Treatment as usual

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Insomnia Severity Index
Lasso di tempo: 3-month follow-up (23weeks post-treatment)
Insomnia Measure
3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale
Lasso di tempo: 10 weeks Post-treatment
Depression measure
10 weeks Post-treatment
Hamilton Depression Scale
Lasso di tempo: 3 Month follow-up (23 weeks post treatment)
Depression Measure
3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index
Lasso di tempo: 10 weeks Post-treatment
Insomnia Measure
10 weeks Post-treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
GDS
Lasso di tempo: Pre-Treatment (Baseline/Week 0)
Self-reported Geriatric Depression Scale
Pre-Treatment (Baseline/Week 0)
SOL
Lasso di tempo: Pre-Treatment (Baseline/Week 0)
self-reported Sleep Onset Latency
Pre-Treatment (Baseline/Week 0)
WASO
Lasso di tempo: Pre-Treatment (Baseline/Week 0)
Wake-time After Sleep Onset
Pre-Treatment (Baseline/Week 0)
SOL
Lasso di tempo: 10 weeks Post-treatment
Self-reported Sleep onset latency
10 weeks Post-treatment
SOL
Lasso di tempo: 3-month follow-up (23weeks post-treatment)
Self-reported Sleep onset latency
3-month follow-up (23weeks post-treatment)
GDS
Lasso di tempo: 10 weeks Post-treatment
Self Reported Geriatric Depression Scale
10 weeks Post-treatment
GDS
Lasso di tempo: 3-month follow-up (23weeks post-treatment)
Self-reported Geriatric Depression Scale
3-month follow-up (23weeks post-treatment)
WASO
Lasso di tempo: 10 weeks Post-treatment
Wake-time After Sleep Onset
10 weeks Post-treatment
WASO
Lasso di tempo: 3-month follow-up (23weeks post-treatment)
Wake-time After Sleep Onset
3-month follow-up (23weeks post-treatment)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa
  • Investigatore principale: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2012

Completamento primario (Effettivo)

1 marzo 2015

Date di iscrizione allo studio

Primo inviato

26 giugno 2012

Primo inviato che soddisfa i criteri di controllo qualità

19 luglio 2012

Primo Inserito (Stima)

24 luglio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 dicembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 novembre 2015

Ultimo verificato

1 novembre 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 10-0309
  • 1R34MH086643-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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