Exercise to Prevent Depression and Anxiety in Older Hispanics
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33136
- Jackson Memorial Mental Health Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
Andere Namen:
|
|
Aktiver Komparator: 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.
|
Comic book style informational booklet designed for people with low literacy to educate them on mental illness.
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
Zeitfenster: change from baseline at 16 months
|
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.
|
change from baseline at 16 months
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Zeitfenster: change from baseline at 16 months
|
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
|
change from baseline at 16 months
|
|
Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Zeitfenster: 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
|
change from baseline at 16 months
|
|
Self-efficacy as measured by the General Self-Efficacy Scale
Zeitfenster: 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.
|
change from baseline at 16 months
|
|
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Zeitfenster: 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
|
change from baseline at 16 months
|
|
Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Zeitfenster: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR
|
change from baseline at 16 months
|
|
Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Daniel E Jimenez, Ph.D., University of Miami
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 20140607
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .