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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

24. januar 2019 opdateret af: Zindel Segal, University of Toronto

Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.

Many patients report residual depressive symptoms despite seemingly successful treatment. With the investigators' previous funding, we developed - Mindful Mood Balance - an online treatment that targets RDS by teaching specific emotion regulation and depression self-management skills that are entirely compatible with antidepressant treatment. The investigators now propose a controlled study to determine whether MMB is more effective than usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery format would provide high fidelity and low-cost empirically supported management of residual symptoms, leading to more robust remission, improved functioning and sustained recovery from MDD over time.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Residual depressive symptoms (RDS) following remission of major depressive disorder (MDD) are reported by 80-90% of adults receiving first-line antidepressant pharmacotherapy and carry an elevated risk for a chronic course of illness, rapid relapse and functional impairment. Strategies for managing residual symptoms, however, have met with mixed success. Mindful Mood Balance (MMB; R34 MH0877223) is an individually tailored, web-based treatment designed to train remitted depressed patients to disengage from dysphoria-activated depressogenic thinking that perpetuates RDS and increases risk for relapse/recurrence. MMB was developed to increase access to Mindfulness-Based Cognitive Therapy (MBCT; R01 MH066992), an empirically supported prophylactic group treatment that can be easily sequenced with acute phase antidepressant pharmacotherapy. Results from our open trial of MMB (N=100) showed an effect size of d=1.09 for pre to post treatment reductions in depression scores among patients with RDS and d=1.54 in a quasi-experimental comparison to patients receiving usual care, with an on average reduction of 1.98 points on the PHQ-9 for MMB patients. The investigators now propose a pragmatic randomized clinical trial of MMB to evaluate its effectiveness in reducing RDS in recurrently depressed patients. Patients will be members of Kaiser-Permanente Colorado (N = 460), aged 18 to 75, who score >5 and <9 on the PHQ-9, in remission from MDD and will be randomized 1:1 to either the usual depression care pathway (DepCare) or Mindful Mood Balance (MMB)+DepCare.

The investigators plan to test whether patients receiving MMB+DepCare will show greater reductions in RDS at both 8 week and 12 months follow up, than those receiving DepCare alone. The investigators are also interested in examining whether fewer patients in MMB+DepCare will relapse over the follow up and will have higher end state functioning and quality of life. In order to examine the costs associated with adding this online treatment to the Depression Care Pathways at KPCO, the investigators will calculate the marginal costs per additional number of depression free days (DFDs) for patients. Resolution of RDS can reduce the enormous personal and social costs experienced by Americans with this persistent symptom burden.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

460

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater, 80237-8066
        • Kaiser Permanente Institute for Health Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with a PHQ-9 score between 5 and 9
  • At least one prior episode of MDD

Exclusion Criteria:

  • presence of schizophrenia or current psychosis, organic mental disorder or pervasive developmental delay

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindful Mood Balance
An 8 session internet intervention targeting residual depressive symptoms.
Adfærdsmæssigt: Usual Depression Care
Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
Adfærdsmæssigt: Mindful Mood Balance
Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990). Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
Aktiv komparator: Usual Depression Care
Usual Depression Care through Kaiser Permanente Colorado
Adfærdsmæssigt: Usual Depression Care
Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Health Questionnaire-9
Tidsramme: Change from Baseline to 12 weeks and 15 months
Changes in self reported depressive symptom severity
Change from Baseline to 12 weeks and 15 months
Patient Health Questionnaire-9
Tidsramme: Between 12 weeks and 15 months
Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9
Between 12 weeks and 15 months
Patient Health Questionnaire-9
Tidsramme: Between baseline to 12 weeks.
Conversion from moderate/high risk to low risk symptom categories, defined as a patient whose PHQ-9 score drops from a baseline PHQ-9 score between 5 and 9 to a mean score of 4 or less
Between baseline to 12 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ruminative Responses Scale
Tidsramme: Change from Baseline to 6 weeks, 12 weeks and 15 months
A self-report measure of rumination
Change from Baseline to 6 weeks, 12 weeks and 15 months
Five Facet Mindfulness Questionnaire
Tidsramme: Change from Baseline to 6 weeks, 12 weeks and 15 months
Self report measure of mindful awareness
Change from Baseline to 6 weeks, 12 weeks and 15 months
Five Facet Mindfulness Scale
Tidsramme: Change from Baseline to 6 weeks, 12 weeks and 15 months
Self report measure of mindful awareness
Change from Baseline to 6 weeks, 12 weeks and 15 months
Experiences Questionnaire
Tidsramme: Change from Baseline to 6 weeks, 12 weeks and 15 months
Self report measure of decentering/wider awareness
Change from Baseline to 6 weeks, 12 weeks and 15 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression Free Days
Tidsramme: Change from Baseline to 12 weeks and 15 months
Self report of days free of depression
Change from Baseline to 12 weeks and 15 months
Generalized Anxiety Disorder Assessment - 7
Tidsramme: Change from Baseline to 12 weeks and 15 months
Self report measure of generalized anxiety
Change from Baseline to 12 weeks and 15 months
Short Form Health Survey - 12
Tidsramme: Change from Baseline to 12 weeks and 15 months
Self report measure of physical and mental health
Change from Baseline to 12 weeks and 15 months
Emotion Dot Probe Task
Tidsramme: Change from Baseline to 12 weeks and 15 months
A behavioural measure of attentional bias
Change from Baseline to 12 weeks and 15 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Toronto

Samarbejdspartnere

Kaiser Permanente
University of Colorado, Boulder

Efterforskere

  • Ledende efterforsker: Zindel V Segal, PhD, University of Toronto

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2015

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Faktiske)

1. november 2018

Datoer for studieregistrering

Først indsendt

10. juli 2014

Først indsendt, der opfyldte QC-kriterier

11. juli 2014

Først opslået (Skøn)

15. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01MH102229-01A1 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Depressive symptomer

Kliniske forsøg med Usual Depression Care

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Betingelser

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