Clinical trial NCT02597686: The STAGE Study for Bipolar Disorder
Official title: A Pilot Study of a Brief Self-distancing and Perspective Broadening Training Package for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Medical Research Council Cognition and Brain Sciences Unit
First posted: 2015-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Quick Inventory of Depressive Symptomatology
timeFrame: 21 days
measure: The Altman Self Rating Mania Scale
timeFrame: 21 days
Secondary outcomes:
measure: The Experiences Questionnaire
timeFrame: over 5 weeks
measure: The Cognitive Emotion Regulation Questionnaire
timeFrame: over 5 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia, Doctorate in Clinical Psychology
Study officials:
References: