- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01544205
Neurofeedback as a Treatment Tool for Depression (NFD)
13. desember 2016 oppdatert av: David Linden, Cardiff University
fMRI Based Neurofeedback as a Treatment Method for Depression
The purpose of the study is to investigate whether neurofeedback delivered via functional magnetic resonance imaging signals can be used to train depressed patients to self-regulate emotion networks and whether this improves clinical symptoms.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
43
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Wales
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Cardiff, Wales, Storbritannia, CF14 4XN
- School of Medicine, Cardiff University
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Cardiff, Wales, Storbritannia, CF103AT
- CUBRIC
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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:
- major depressive disorder (MDD) diagnosis
- stable antidepressant dose medication
Exclusion Criteria:
- Other physical or psychiatric disorders
- Current substance abuse
- Current psychotherapy or other specific intervention
- Exclusion criteria applicable to MRI
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Emotion network up-regulation
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).
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5 sessions lasting one hour each
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Aktiv komparator: Place processing network up-regulation
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to place and house pictures (as identified during a functional localiser scan).
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5 sessions lasting one hour each
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
Tidsramme: Before start trial (baseline), after intervention (appr. 2 months)
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Before start trial (baseline), after intervention (appr. 2 months)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up
Tidsramme: Baseline, 3-month follow-up
|
Baseline, 3-month follow-up
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Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
|
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
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Baseline, end of intervention (appr. 2 months)
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Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
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Change from Baseline in the Quality of Life Scale (QOLS) at follow-up
Tidsramme: Baseline, 3-month follow-up
|
Baseline, 3-month follow-up
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Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
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Baseline, end of intervention (appr. 2 months)
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Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
|
|
Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
|
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Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
|
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Change from Baseline in the Thought control questionnaire (TCQ) at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Change from Baseline in the Thought control ability questionnaire (TCAQ) at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
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Baseline, end of intervention (appr. 2 months)
|
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Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up
Tidsramme: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
|
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Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up
Tidsramme: Baseline, 3-month follow-up
|
Baseline, 3-month follow-up
|
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Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at the end of intervention (after 5th session)
Tidsramme: Baseline, end of intervention (appr. 2 months)
|
Baseline, end of intervention (appr. 2 months)
|
|
Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up
Tidsramme: Baseline, 3-months follow-up
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Baseline, 3-months follow-up
|
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Change from Baseline in health service resource use as measured with a Resource Use Questionnaire
Tidsramme: Baseline, 3-months follow-up
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Baseline, 3-months follow-up
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Change from before to after scan in the Profile of Mood States (POMS)
Tidsramme: Before and after each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)
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Measure to address any imminent changes in mood state.
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Before and after each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)
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Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control
Tidsramme: Integrating imaging and psychometric data across the intervention period (appr. 2 months)
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Analysis of the relationship between scores on the self-efficacy scales, thought control questionnaire (TCQ), thought control ability questionnaire (TCAQ) and the behavioural inhibition system and behavioural activation system (BIS/BAS) scales and fMRI data.
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Integrating imaging and psychometric data across the intervention period (appr. 2 months)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: David E Linden, MD, Cardiff University
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
- Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. doi: 10.1016/j.neuroimage.2009.07.056. Epub 2009 Jul 29.
- Johnston S, Linden DE, Healy D, Goebel R, Habes I, Boehm SG. Upregulation of emotion areas through neurofeedback with a focus on positive mood. Cogn Affect Behav Neurosci. 2011 Mar;11(1):44-51. doi: 10.3758/s13415-010-0010-1.
- Fovet T, Jardri R, Linden D. Current Issues in the Use of fMRI-Based Neurofeedback to Relieve Psychiatric Symptoms. Curr Pharm Des. 2015;21(23):3384-94. doi: 10.2174/1381612821666150619092540.
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
1. mars 2012
Primær fullføring (Faktiske)
1. september 2014
Studiet fullført (Faktiske)
1. september 2014
Datoer for studieregistrering
Først innsendt
23. februar 2012
Først innsendt som oppfylte QC-kriteriene
28. februar 2012
Først lagt ut (Anslag)
5. mars 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPON927-11
- G 1100629 (Annet stipend/finansieringsnummer: MRC)
- HS/10/25 (Annet stipend/finansieringsnummer: NISCHR)
- 11/WA/0106 (Annen identifikator: NHS Research Ethics Committee)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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