Testing av en livsstilsintervensjon for fysisk aktivitet for kvinner med depresjon i alkoholbehandling (HEART)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02906
- Butler Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: LPA+Fitbit
Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data |
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. |
|
Aktiv komparator: Fitbit Only
Participants in this group are provided with a Fitbit to collect activity data |
Participants are provided with a Fitbit during their study participation. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Likelihood of drinking alcohol during early recovery (first 3 months)
Tidsramme: 3 months
|
Timeline Follow-back Interview will be used to determined the likelihood participants drank alcohol on any given day during the time frame assessed. |
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Likely of drinking alcohol in the first year (12 months)
Tidsramme: 12 months
|
Timeline Follow-back Interview will be used to determined the likelihood participants drank alcohol on any given day during the time frame assessed. |
12 months
|
|
Alcohol-Related Consequences
Tidsramme: 12 months
|
The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period. |
12 months
|
|
Depressive symptoms
Tidsramme: 12 months
|
Symptoms of depression, as measured by the Patient Health Questionnaire-9 |
12 months
|
|
Physical Activity levels
Tidsramme: 12 months
|
Objectively measured steps/day with a Fitbit |
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ana Abrantes, PhD, Butler Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202006-001
- R01AA028186 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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