- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alabama
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Tuscaloosa, Alabama, États-Unis, 35487
- UATuscaloosa
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Comparateur actif: Treatment as Usual
No additional treatment besides regular care.
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Standard Care - Treatment as usual
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insomnia Severity Index
Délai: 3-month follow-up (23weeks post-treatment)
|
Insomnia Measure
|
3-month follow-up (23weeks post-treatment)
|
|
Hamilton Depression Scale
Délai: 10 weeks Post-treatment
|
Depression measure
|
10 weeks Post-treatment
|
|
Hamilton Depression Scale
Délai: 3 Month follow-up (23 weeks post treatment)
|
Depression Measure
|
3 Month follow-up (23 weeks post treatment)
|
|
Insomnia Severity Index
Délai: 10 weeks Post-treatment
|
Insomnia Measure
|
10 weeks Post-treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
GDS
Délai: Pre-Treatment (Baseline/Week 0)
|
Self-reported Geriatric Depression Scale
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Pre-Treatment (Baseline/Week 0)
|
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SOL
Délai: Pre-Treatment (Baseline/Week 0)
|
self-reported Sleep Onset Latency
|
Pre-Treatment (Baseline/Week 0)
|
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WASO
Délai: Pre-Treatment (Baseline/Week 0)
|
Wake-time After Sleep Onset
|
Pre-Treatment (Baseline/Week 0)
|
|
SOL
Délai: 10 weeks Post-treatment
|
Self-reported Sleep onset latency
|
10 weeks Post-treatment
|
|
SOL
Délai: 3-month follow-up (23weeks post-treatment)
|
Self-reported Sleep onset latency
|
3-month follow-up (23weeks post-treatment)
|
|
GDS
Délai: 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
Délai: 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
Délai: 10 weeks Post-treatment
|
Wake-time After Sleep Onset
|
10 weeks Post-treatment
|
|
WASO
Délai: 3-month follow-up (23weeks post-treatment)
|
Wake-time After Sleep Onset
|
3-month follow-up (23weeks post-treatment)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa
- Chercheur principal: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10-0309
- 1R34MH086643-01A2 (Subvention/contrat des NIH des États-Unis)
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