Neurofeedback as a Treatment Tool for Depression (NFD)
13 december 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
43
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Wales
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Cardiff, Wales, Storbritannien, CF14 4XN
- School of Medicine, Cardiff University
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Cardiff, Wales, Storbritannien, CF103AT
- CUBRIC
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up
Tidsram: 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) anxiety score at the end of intervention (after 5th session)
Tidsram: 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) anxiety score at follow-up
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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 Quality of Life Scale (QOLS) at follow-up
Tidsram: Baseline, 3-month follow-up
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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)
Tidsram: 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
Tidsram: Baseline, 3-month follow-up
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Baseline, 3-month follow-up
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session)
Tidsram: 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 Self-efficacy-scale (general subscale: GSE) at follow-up
Tidsram: 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)
Tidsram: 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 Self-efficacy-scale (social subscale: SSE) at follow-up
Tidsram: 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)
Tidsram: 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 questionnaire (TCQ) at follow-up
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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 Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up
Tidsram: 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), BIS scale, at the end of intervention (after 5th session)
Tidsram: 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 Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: David E Linden, MD, Cardiff University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2012
Primärt slutförande (Faktisk)
1 september 2014
Avslutad studie (Faktisk)
1 september 2014
Studieregistreringsdatum
Först inskickad
23 februari 2012
Först inskickad som uppfyllde QC-kriterierna
28 februari 2012
Första postat (Uppskatta)
5 mars 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 december 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SPON927-11
- G 1100629 (Annat bidrag/finansieringsnummer: MRC)
- HS/10/25 (Annat bidrag/finansieringsnummer: NISCHR)
- 11/WA/0106 (Annan identifierare: NHS Research Ethics Committee)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .