- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01178424
My Depression Wellness Toolkit Study
Major depressive disorder (MDD) continues to have a profound impact on individuals, families, and the health care system. Despite marked success in treating active individual episodes of unipolar depression, our understanding of the neural and cognitive mechanisms involved in the return of symptoms remains extremely limited, and few interventions exist that specifically target factors involved in prophylaxis. The research being proposed is among the first that is designed to examine neurocognitive markers for depressive relapse vulnerability and link them directly to clinical prognosis.
Hypothesis 1: Cortical midline structures (CMS) network recruitment will be associated with behavioural and neural indices of a reflexive attentional bias towards dysphoric stimuli in a divided attention task.
Hypothesis 2: Behavioural and neural indices of dysphoric attentional bias following mood challenge will predict depression relapse in prospective 18-month follow up.
Hypothesis 3: Relative to CBT, Mindfulness Based Cognitive Therapy (MBCT) will normalize CMS and right insular/fronto-opercular cortices (INS-FO) network imbalance.
Hypothesis 4: Relative to CBT, MBCT will normalize to healthy control levels, behavioural and neural indices of dysphoric attentional bias, which will be predictive of reduced relapse risk across a 24 month follow up.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Women or men 18-65 years of age
- Meeting criteria for prior depression, currently in recovery or remission, according to Diagnostic and Statistical Manual of Mental Disorders (4th eg; DSM-IV-TR, (American Psychiatric Association, 2000)
- A baseline score of ≤ 12 on the HRSD (Hamilton, 1960)
- Internet access
- English proficiency at or above a grade 8 level
Exclusion Criteria:
- Schizophrenia or current psychosis
- Organic mental disorder
- Pervasive developmental delay (PDD)
- Current substance dependence
- Imminent suicide or homicide risk
- Axis I or II disorder that necessitates primary treatment not provided in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is a manualized, group skills training program (Segal et al., 2013) 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 participate in 8 weekly sessions, each of which incorporates didactic and experiential learning, along with home practice of mindfulness skills taught in the program.
|
Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2013) 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 participate in 8 weekly sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
|
Aktiv komparator: Cognitive Behaviour Therapy
CBT is an evidence based depression-specific psychotherapy that examines the relationship between thinking styles and the perpetuation of mood symptoms in major depression.
Patients use thought records and activity scheduling, among other tools, to record and reappraise their thinking during situations where negative affect is present, both in session and for homework.
|
CBT is an evidence based depression-specific psychotherapy that examines the relationship between thinking styles and the perpetuation of mood symptoms in major depression.
Patients use thought records and activity scheduling, among other tools, to record and reappraise their thinking during situations where negative affect is present, both in session and for homework.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rates of relapse/recurrence based on CMS and INS/FO configuration.
Tidsramme: 2 years
|
Patients who relapse will show Increased neural activation in CMS compared to INS/FO regions compared to non relapsers
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes in CMS and INSFO network imbalance following MBCT compared to CBT
Tidsramme: 2 years
|
Patients in MBCT will show greater levels of activation in INS/FO compared to patients in CBT
|
2 years
|
Changes in attentional processing of dysphoric stimuli between the groups
Tidsramme: 8 weeks
|
Relapsers will show greater attention to negative self-descriptive adjectives compared to non-relapsers.
|
8 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Zindel V. Segal, PhD, Centre for Addiction and Mental Health
Publikationer og nyttige links
Generelle publikationer
- Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
- Farb NA, Segal ZV, Mayberg H, Bean J, McKeon D, Fatima Z, Anderson AK. Attending to the present: mindfulness meditation reveals distinct neural modes of self-reference. Soc Cogn Affect Neurosci. 2007 Dec;2(4):313-22. doi: 10.1093/scan/nsm030.
- Farb NA, Anderson AK, Mayberg H, Bean J, McKeon D, Segal ZV. Minding one's emotions: mindfulness training alters the neural expression of sadness. Emotion. 2010 Feb;10(1):25-33. doi: 10.1037/a0017151. Erratum In: Emotion. 2010 Apr;10(2):215.
- Segal, Z. V., Williams, J. M., & Teasdale, J. D. (2013). Mindfulness-based cognitive therapy for depression (2nd ed.). New York: Guilford Press.
- Farb NAS, Desormeau P, Anderson AK, Segal ZV. Static and treatment-responsive brain biomarkers of depression relapse vulnerability following prophylactic psychotherapy: Evidence from a randomized control trial. Neuroimage Clin. 2022;34:102969. doi: 10.1016/j.nicl.2022.102969. Epub 2022 Feb 19.
- Segal ZV, Anderson AK, Gulamani T, Dinh Williams LA, Desormeau P, Ferguson A, Walsh K, Farb NAS. Practice of therapy acquired regulatory skills and depressive relapse/recurrence prophylaxis following cognitive therapy or mindfulness based cognitive therapy. J Consult Clin Psychol. 2019 Feb;87(2):161-170. doi: 10.1037/ccp0000351. Epub 2018 Nov 15.
- Farb N, Anderson A, Ravindran A, Hawley L, Irving J, Mancuso E, Gulamani T, Williams G, Ferguson A, Segal ZV. Prevention of relapse/recurrence in major depressive disorder with either mindfulness-based cognitive therapy or cognitive therapy. J Consult Clin Psychol. 2018 Feb;86(2):200-204. doi: 10.1037/ccp0000266. Epub 2017 Dec 21.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 093/2010
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