- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02597686
The STAGE Study for Bipolar Disorder
A Pilot Study of a Brief Self-distancing and Perspective Broadening Training Package for Bipolar Disorder
When the investigators are caught up in emotions, it is by stepping back (or decentering) that the investigators are able to see the situation from another perspective. Individuals with emotional disorders, however, can have difficulties in being able to do this.
Research has shown that improving an individual's ability to step back from their emotions and take perspective is possible and can have beneficial effects on depressive symptomatology (Self Distancing and Perspective Broadening [SDPB] training). The SDPB training package involves two techniques: 1) stepping back from situations using mental imagery (building a mental picture of the situation and changing the distance to it) and, 2) reframing situations using perspective broadening reappraisals (giving new meanings to situations). The training package trains these SDPB techniques using an individual's memories and every day events. The fortnightly training comprises of two one to one sessions and daily homework for a week in between.The SDPB training package is aimed at improving an individual's ability to step back from, and put a new meaning to emotional events that take place in their lives.
The prospective pilot study aims to investigate whether the SDPB training package reduces symptomatology and improves these abilities in individuals who experience both depressive and manic episodes (Bipolar Disorder [BD]).
BD has a cumulative lifetime prevalence ranging from 1.52% across Europe and is treated with moderate success using Cognitive Behavioural therapy (CBT). However, 'moderate success' is considerably low compared to other mental health problems and CBT can be time time consuming, expensive, and cognitively demanding (requiring a high level of functioning of one or more cognitive functions). Accordingly, BD may be one of the emotional disorders in greatest need of novel and evidence based treatments.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Norwich, Storbritannia, NR4 7TJ
- Rekruttering
- University of East Anglia, Doctorate in Clinical Psychology
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Ta kontakt med:
- Emma Hill
- E-post: emma.l.hill@uea.ac.uk
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Hovedetterforsker:
- Emma Hill, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria include:
- Individuals with a diagnosis of Bipolar Disorder whom are at the time of testing in a euthymic state (not in an episode of depression or mania).
Exclusion criteria include:
- Current substance dependence or abuse
- Current CBT treatment
- Individuals who are not fluent in English
- Organic brain injury
- Active psychotic and manic symptoms requiring hospitalisation
- Active suicidal risk.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: SD-PB training
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Quick Inventory of Depressive Symptomatology
Tidsramme: 21 days
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A modified daily measure of depressive symptoms
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21 days
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The Altman Self Rating Mania Scale
Tidsramme: 21 days
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A modified daily measure of mania symptoms
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21 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Experiences Questionnaire
Tidsramme: over 5 weeks
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A measure of the ability to decenter
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over 5 weeks
|
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The Cognitive Emotion Regulation Questionnaire
Tidsramme: over 5 weeks
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A measure of the ability to perspective-take
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over 5 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UEastAnglia
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