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The STAGE Study for Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SD-PB training
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of East Anglia, Doctorate in Clinical PsychologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SD-PB training

Arm Description

Outcomes

Primary Outcome Measures

The Quick Inventory of Depressive Symptomatology
A modified daily measure of depressive symptoms
The Altman Self Rating Mania Scale
A modified daily measure of mania symptoms

Secondary Outcome Measures

The Experiences Questionnaire
A measure of the ability to decenter
The Cognitive Emotion Regulation Questionnaire
A measure of the ability to perspective-take

Full Information

First Posted
October 23, 2015
Last Updated
February 5, 2016
Sponsor
University of East Anglia
Collaborators
Medical Research Council Cognition and Brain Sciences Unit
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1. Study Identification

Unique Protocol Identification Number
NCT02597686
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia
Collaborators
Medical Research Council Cognition and Brain Sciences Unit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SD-PB training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
SD-PB training
Primary Outcome Measure Information:
Title
The Quick Inventory of Depressive Symptomatology
Description
A modified daily measure of depressive symptoms
Time Frame
21 days
Title
The Altman Self Rating Mania Scale
Description
A modified daily measure of mania symptoms
Time Frame
21 days
Secondary Outcome Measure Information:
Title
The Experiences Questionnaire
Description
A measure of the ability to decenter
Time Frame
over 5 weeks
Title
The Cognitive Emotion Regulation Questionnaire
Description
A measure of the ability to perspective-take
Time Frame
over 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Hill
Email
emma.l.hill@uea.ac.uk
Facility Information:
Facility Name
University of East Anglia, Doctorate in Clinical Psychology
City
Norwich
ZIP/Postal Code
NR4 7TJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Hill
Email
emma.l.hill@uea.ac.uk
First Name & Middle Initial & Last Name & Degree
Emma Hill, PhD

12. IPD Sharing Statement

Learn more about this trial

The STAGE Study for Bipolar Disorder

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