The STAGE Study for Bipolar Disorder
A Pilot Study of a Brief Self-distancing and Perspective Broadening Training Package for Bipolar Disorder
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFebruary 8, 2016
November 1, 2015
5 months
October 23, 2015
February 5, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
The Quick Inventory of Depressive Symptomatology
A modified daily measure of depressive symptoms
21 days
The Altman Self Rating Mania Scale
A modified daily measure of mania symptoms
21 days
Secondary Outcomes (2)
The Experiences Questionnaire
over 5 weeks
The Cognitive Emotion Regulation Questionnaire
over 5 weeks
Study Arms (1)
SD-PB training
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of East Anglia, Doctorate in Clinical Psychology
Norwich, NR4 7TJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2015
First Posted
November 5, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Study Completion
September 1, 2016
Last Updated
February 8, 2016
Record last verified: 2015-11