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Eine Studie entspricht den Filterkriterien
Kartenansicht
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment (HEART)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04667520 (HEART) ist eine interventionsstudie zur Untersuchung von Alkoholkonsumstörung, Depression und hat den Status offene rekrutierung. Die Studie startete am 10. Mai 2021 und soll 214 Teilnehmer aufnehmen. Durchgeführt von Butler Hospital ist der Abschluss für 30. Juni 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. April 2025 aktualisiert.
Kurzbeschreibung
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.
Ausführliche Beschreibung
Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men. Physical activity (PA) interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse.
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 & 2, 5 & 6, and again at weeks 11 & 12.
Offizieller Titel
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Erkrankungen
AlkoholkonsumstörungDepressionWeitere Studien-IDs
- HEART
- 202006-001
- R01AA028186 (Zuwendung/Vertrag der US-NIH)
NCT-Nummer
Studienbeginn (tatsächlich)
2021-05-10
Zuletzt aktualisiert
2025-04-06
Studienende (vorauss.)
2026-06-30
Geplante Rekrutierung
214
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellLPA+Fitbit Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data | Lifestyle Physical Activity (LPA) This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation. |
Aktives VergleichspräparatFitbit Only Participants in this group are provided with a Fitbit to collect activity data | Nur Fitbit Participants are provided with a Fitbit during their study participation. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Percent of sample that is abstinent from alcohol | Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed. | 12 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Alcohol-Related Consequences | The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period. | 12 months |
Depressive symptoms | Symptoms of depression, as measured by the Patient Health Questionnaire-9 | 12 months |
Physical Activity levels | Objectively measured steps/day with a Fitbit | 12 months |
Alcohol Abstinence Self-Efficacy | Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale | 12 months |
Cardiorespiratory Fitness (estimated peak VO2) | Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test | 12 months |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
- female
- between 18 and 65 years of age
- score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2)
- Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months)
- are currently engaged in alcohol treatment
- own a smartphone - to allow for EMA software and Fitbit application
- current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
- a history of psychotic disorder or current psychotic symptoms
- current suicidality or homicidality
- current mania
- marked organic impairment according to either the medical record or responses to the diagnostic assessments
- physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician)
- current pregnancy or intent to become pregnant during the next 12 weeks
Butler HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Zentrale Studienkontakte
Kontakt: Ana Abrantes, PhD, 401-455-6652, [email protected]
Kontakt: Debra Herman, PhD, 401-455-6652, [email protected]
1 Studienstandorte in 1 Ländern
Rhode Island
Butler Hospital, Providence, Rhode Island, 02906, United States
Ana M Abrantes, Ph.D., Kontakt, 401-455-6440
Julie Desaulniers, M.S., Kontakt, 401-455-6219
Offene Rekrutierung