Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
24 april 2018 uppdaterad av: Margit I. Berman, Dartmouth-Hitchcock Medical Center
Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial
The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself!
compared to a commercial behavioral weight loss program, Weight Watchers (WW).
Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments.
Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New Hampshire
-
Lebanon, New Hampshire, Förenta staterna, 03766
- Dartmouth-Hitchcock Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- English-speaking
- Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
- Body Mass Index (BMI) greater than or equal to 30
- Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)
Exclusion Criteria:
- current substance dependence
- history of psychotic symptoms
- high risk of suicide/self-harm
- current enrollment in a weight-loss program
- weight loss surgery in the past year
- current psychotherapy
- inability to postpone weight loss or depression treatment interventions for the duration of the study
- taking antipsychotic, tricyclic, or oral corticosteroid medication
- unwilling to be randomized to the study treatments
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Accept Yourself! Intervention
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
|
Andra namn:
|
|
Aktiv komparator: Behavioral Weight Loss
Weight Watchers groups
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in clinician assessed depression symptoms
Tidsram: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
|
Change in self-reported depression symptoms
Tidsram: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
As assessed by Patient Health Questionnaire-9 (PHQ-9)
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in fasting Lipids
Tidsram: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
|
At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
|
|
|
Change in systolic and diastolic blood pressure
Tidsram: At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
|
|
Change in fasting blood glucose
Tidsram: At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
|
|
Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)
Tidsram: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
|
|
Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)
Tidsram: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
|
|
Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
Tidsram: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
|
|
Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
Tidsram: At post-treatment (immediately following the three-month intervention)
|
At post-treatment (immediately following the three-month intervention)
|
|
|
Change in weight
Tidsram: At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).
|
At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
|
Change in self-reported physical activity
Tidsram: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
|
|
Change in cardiovascular fitness as assessed by six-minute walk test
Tidsram: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Margit I Berman, Ph.D, Dartmouth College
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 augusti 2015
Primärt slutförande (Faktisk)
7 maj 2017
Avslutad studie (Faktisk)
7 maj 2017
Studieregistreringsdatum
Först inskickad
14 juli 2015
Först inskickad som uppfyllde QC-kriterierna
15 juli 2015
Första postat (Uppskatta)
17 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D15151
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .