- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02371954
Exercise to Prevent Depression and Anxiety in Older Hispanics
6 septembre 2018 mis à jour par: Daniel Enrique Jimenez, University of Miami
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Eligible participants will be randomized to either the Happy Older Latinos are Active (HOLA) intervention or a psychoeducation condition.
Participants randomized to HOLA will participate in a group exercise, 3 times a week, for 16 weeks.
The exercise is a moderate intensity walk at a centrally located park in Miami-Dade county and will last for an hour (10 minute warmup/stretching, 30 minute walk, 5 minute cool down).
Groups will consist of 6 participants and be led by a community health worker.
During the cool down phase, participants will plan a pleasant event to be done in between sessions.
Participants randomized to the psychoeducation component will receive a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received.
These discussion groups will last one hour and will consist of 10 participants.
A total of 60 participants will be randomized (30 to HOLA, 30 to fotonovela).
Assessments will be conducted at baseline, post intervention, 6 months post-intervention, and 12 months post-intervention.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Florida
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Miami, Florida, États-Unis, 33136
- Jackson Memorial Mental Health Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Hispanic (self-identified);
- Age 60+;
- Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2);
- Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the MINI);
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
- Medical clearance for participation in an exercise program by a physician, physician's assistant, or nurse practitioner;
- Expect to be resident in Miami for the subsequent 12 months.
Exclusion Criteria:
- Currently residing in a nursing or group home;
- A terminal physical illness expected to result in the death within one year;
- A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24;
- Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months;
- History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder;
- High suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
- Participants taking cognitive enhancing medication or psychotropic medications (e.g. antidepressants);
- unable to complete 400 m walk test in less than 15 min;
- if participant heart rate exceeded 170 beats per minute OR systolic blood pressure exceeds 180 during 400 m walk test;
- chest or leg pain, dyspnea, dizziness, feeling faint, or other significant symptoms while completing 400 m walk test;
(i) acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Health Promotion
Happy Older Latinos are Active (HOLA) is multicomponent health promotion intervention led by a community health worker (CHW).
First component is a social and physical activation session.
Participants meet individually with CHW for 30 minutes once at week 1, then again at week 8 (the midway point).
Second component is a moderate intensity group walk.
Groups will consist of 6 participants and will meet for one hour, 3 times a week, for 16 weeks.
Third component is pleasant events scheduling during cool down phase of the group walk.
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Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
Autres noms:
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Comparateur actif: Psychoeducation
Participants will be given a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received.
These discussion groups will last one hour and will consist of 10 participants.
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Comic book style informational booklet designed for people with low literacy to educate them on mental illness.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
Délai: change from baseline at 16 months
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I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.
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change from baseline at 16 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Délai: change from baseline at 16 months
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I will be measuring the effect the HOLA intervention has on the scores of the Getting Around, Life Activities, and Self-Care subscales of the WHO-DAS 2.0
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change from baseline at 16 months
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Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Délai: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on the scores of the Getting Along with People and Participation in Life subscales of the WHO-DAS 2.0
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change from baseline at 16 months
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Self-efficacy as measured by the General Self-Efficacy Scale
Délai: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on total scores of the General-Self Efficacy Scale.
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change from baseline at 16 months
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Sleep quality as measured by the Pittsburgh Sleep Quality Index
Délai: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on the total scores of the Pittsburgh Sleep Quality Index
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change from baseline at 16 months
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Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Délai: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR
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change from baseline at 16 months
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Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
Délai: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on the total scores of the BAI
|
change from baseline at 16 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Daniel E Jimenez, Ph.D., University of Miami
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2013
Achèvement primaire (Réel)
1 août 2018
Achèvement de l'étude (Réel)
1 août 2018
Dates d'inscription aux études
Première soumission
21 janvier 2015
Première soumission répondant aux critères de contrôle qualité
20 février 2015
Première publication (Estimation)
26 février 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 septembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 septembre 2018
Dernière vérification
1 septembre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20140607
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .