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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

24 januari 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

460

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Colorado
  - Denver, Colorado, Verenigde Staten, 80237-8066
    - Kaiser Permanente Institute for Health Research

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

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

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: Dubbele

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Mindful Mood Balance An 8 session internet intervention targeting residual depressive symptoms.	Gedragsmatig: 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. Gedragsmatig: 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.
Actieve vergelijker: Usual Depression Care Usual Depression Care through Kaiser Permanente Colorado	Gedragsmatig: 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.

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: Mindful Mood Balance

An 8 session internet intervention targeting residual depressive symptoms.

Gedragsmatig: 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.

Gedragsmatig: 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.

Actieve vergelijker: Usual Depression Care

Usual Depression Care through Kaiser Permanente Colorado

Gedragsmatig: Usual Depression Care

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Patient Health Questionnaire-9 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Ruminative Responses Scale Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Depression Free Days Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: Change from Baseline to 12 weeks and 15 months	A behavioural measure of attentional bias	Change from Baseline to 12 weeks and 15 months

Medewerkers en onderzoekers

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

Sponsor

University of Toronto

Medewerkers

Kaiser Permanente

University of Colorado, Boulder

Onderzoekers

Hoofdonderzoeker: Zindel V Segal, PhD, University of Toronto

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Mindfulness Based Cognitive Therapy Website

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 (Werkelijk)

1 maart 2015

Primaire voltooiing (Werkelijk)

1 november 2018

Studie voltooiing (Werkelijk)

1 november 2018

Studieregistratiedata

Eerst ingediend

10 juli 2014

Eerst ingediend dat voldeed aan de QC-criteria

11 juli 2014

Eerst geplaatst (Schatting)

15 juli 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 januari 2019

Laatste update ingediend die voldeed aan QC-criteria

24 januari 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

R01MH102229-01A1 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance