The STAGE Study for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

A Pilot Study of a Brief Self-distancing and Perspective Broadening Training Package for Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597686
• Other study ID #: UEastAnglia
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2015
• Last updated: February 5, 2016
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2015
• Source: University of East Anglia
• Contact: Emma Hill
• Email: emma.l.hill[@]uea.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• SD-PB training

Locations

Country	Name	City	State
United Kingdom	University of East Anglia, Doctorate in Clinical Psychology	Norwich

Sponsors (2)

Lead Sponsor	Collaborator
University of East Anglia	Medical Research Council Cognition and Brain Sciences Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Quick Inventory of Depressive Symptomatology	A modified daily measure of depressive symptoms	21 days	No
Primary	The Altman Self Rating Mania Scale	A modified daily measure of mania symptoms	21 days	No
Secondary	The Experiences Questionnaire	A measure of the ability to decenter	over 5 weeks	No
Secondary	The Cognitive Emotion Regulation Questionnaire	A measure of the ability to perspective-take	over 5 weeks	No