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Mindfulness-Based Yoga Intervention for Women With Depression

14 december 2015 bijgewerkt door: University of Minnesota
The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, & Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • 18 years of age or older
  • a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)
  • able to read and write in the English language
  • able to commit to two sessions (yoga or walking) per week for 12 weeks
  • demonstrate a willingness to be randomly assigned to either of the study arms
  • be yoga naïve, defined as not taking more than four yoga classes in the past two years and not more than one class in the past month.

Exclusion Criteria:

  • individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening
  • individuals not providing signed informed consent
  • individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions
  • individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mindfulness-based Yoga

Participants in the 12-week mindfulness-based yoga condition were guided by a gentle yoga DVD that included postures (asanas), pranayama (breathing exercises), and relaxation (meditation). Participants were asked to complete 60-75 minutes of the DVD twice per week and were encouraged to do more if they were interested.

Following the initial baseline assessment and randomization telephone interview, participants in the yoga group completed weekly 15-minute telephone sessions for the first month and bi-weekly telephone sessions for the second and third for a total of eight sessions over the 12 weeks. The mindfulness telephone sessions were modified from the Mindfulness-Based Stress Reduction.
Gedragsmatig: Mindfulness-based Yoga
See study arm description.
Actieve vergelijker: Walking Control Group

The 12-week walking control condition included twice-weekly home practice with a 65-minute walking DVD (Sansone, 2008) and eight telephone sessions with the telephone counselor.

Participants were asked to complete 60 minutes of the DVD (or other walking) twice weekly and encouraged to do more if they were interested.

Participants received telephone sessions on the same schedule as the yoga condition. The education sessions covered a variety of health and wellness related topics.
Gedragsmatig: Walking Control Condition
See study arm description.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Beck Depression Inventory
Tijdsspanne: 3 months
Change from Baseline Depression at 3 months
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ruminative Responses Scale
Tijdsspanne: 3 months
Change from Baseline Rumination at 3 months
3 months
Five Facet Mindfulness Questionnaire
Tijdsspanne: 3 months
Change from Baseline Mindfulness at 3 months
3 months
Perceived Stress Scale
Tijdsspanne: 3 months
Change from Perceived Stress at 3 months
3 months
Pittsburgh Sleep Scale
Tijdsspanne: 3 months
Change from Baseline Sleep at 3 months
3 months
Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
Tijdsspanne: 3 months
Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months
3 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body Mass Index
Tijdsspanne: 3 months
Change from Baseline Body Mass Index at 3 months
3 months
7-Day Physical Activity Recall
Tijdsspanne: 3 months
Change from Baseline Physical Activity at 3 months
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Minnesota

Onderzoekers

  • Studie stoel: Beth A Lewis, PHD, L.P., University of Minnesota

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2013

Primaire voltooiing (Werkelijk)

1 mei 2014

Studie voltooiing (Werkelijk)

1 mei 2014

Studieregistratiedata

Eerst ingediend

7 december 2015

Eerst ingediend dat voldeed aan de QC-criteria

14 december 2015

Eerst geplaatst (Schatting)

15 december 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

15 december 2015

Laatste update ingediend die voldeed aan QC-criteria

14 december 2015

Laatst geverifieerd

1 december 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1203P11124

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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