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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

24. januar 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

460

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Colorado
  - Denver, Colorado, Forente stater, 80237-8066
    - Kaiser Permanente Institute for Health Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Mindful Mood Balance An 8 session internet intervention targeting residual depressive symptoms.	Atferdsmessig: 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. Atferdsmessig: 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	Atferdsmessig: 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.

Deltakergruppe / Arm

Intervensjon / Behandling

Eksperimentell: Mindful Mood Balance

An 8 session internet intervention targeting residual depressive symptoms.

Atferdsmessig: 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.

Atferdsmessig: 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

Atferdsmessig: Usual Depression Care

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Toronto

Samarbeidspartnere

Kaiser Permanente

University of Colorado, Boulder

Etterforskere

Hovedetterforsker: Zindel V Segal, PhD, University of Toronto

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Mindfulness Based Cognitive Therapy Website

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2015

Primær fullføring (Faktiske)

1. november 2018

Studiet fullført (Faktiske)

1. november 2018

Datoer for studieregistrering

Først innsendt

10. juli 2014

Først innsendt som oppfylte QC-kriteriene

11. juli 2014

Først lagt ut (Anslag)

15. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance