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Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)

Primary Purpose

Mania, Hypomania, Bipolar Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Interpersonal Therapy
Treatment As Usual
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mania focused on measuring mania, hypomania, bipolar affective disorder, psychological intervention, cognitive therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible individuals will have experienced their first or second treated episode of mania and / or hypomania in the previous 12-months prior to study entry.

Exclusion Criteria:

  • Participants will be excluded if there is a (1) diagnosis of learning disability; (2) inability to participate in psychotherapy/research due to acute medical condition or acute mania

Sites / Locations

  • Gartnavel Royal Hospital
  • NHS Greater Glasgow & Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychological Therapy

Treatment As Usual

Arm Description

Cognitive Interpersonal Therapy (CIT) was a psychological therapy which emphasised assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive-behavioural and interpersonal strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).

All participants continued to receive their usual care from their local community mental health team and other psychological therapies were not withheld during the conduct of the trial.

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)
The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]
The Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are: 0 to 15 - normal /symptom absent 15 to 20 - mild 21 to 28 - moderate >34 - severe

Secondary Outcome Measures

The Internal State Scale (ISS) (Bauer et al, 1991)
The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200). The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows: Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania >155 >125 Mixed State >155 <125 Euthymia <155 >125 Depression <155
Global Assessment of Functioning (GAF)
Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.

Full Information

First Posted
March 7, 2011
Last Updated
July 29, 2014
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Chief Scientist Office of the Scottish Government, University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT01315028
Brief Title
Bipolar Intervention Study: Cognitive Interpersonal Therapy
Acronym
BISCIT
Official Title
A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Chief Scientist Office of the Scottish Government, University of Glasgow

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is a need to develop a better understanding of the early phase of bipolar disorder, and to develop and evaluate effective psychosocial interventions that assist people in this phase. The purpose of this study is to determine whether or not it is feasible to conduct a larger study of the effectiveness of cognitive interpersonal therapy (a psychological therapy) with individuals who have experienced their first or second treated episode of mania or hypomania (symptoms common in early development of bipolar disorders).
Detailed Description
The 'PICO' framework (Oxman, Sackett, and Guyatt, 1993; Richardson, Wilson, Nishikawa, and Hayward; 1995) was used to specify the parameters of the study aims and objectives: Population: could appropriate individuals be identified and recruited to a trial of CIT for early bipolar disorder? Intervention: would CIT be an acceptable intervention for individuals following a first or second treated episode of mania and or hypomania? Could we identify any modifications required to the CIT protocol used with this group? Control group: could an appropriate group of participants be recruited to facilitate a comparison with the CIT intervention? Could we explicitly establish the usual care package and its local implementation? Outcomes: which outcomes are appropriate for measuring relevant dimensions of a treatment effect?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mania, Hypomania, Bipolar Affective Disorder
Keywords
mania, hypomania, bipolar affective disorder, psychological intervention, cognitive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychological Therapy
Arm Type
Experimental
Arm Description
Cognitive Interpersonal Therapy (CIT) was a psychological therapy which emphasised assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive-behavioural and interpersonal strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
All participants continued to receive their usual care from their local community mental health team and other psychological therapies were not withheld during the conduct of the trial.
Intervention Type
Other
Intervention Name(s)
Cognitive Interpersonal Therapy
Other Intervention Name(s)
Psychological Therapy
Intervention Description
Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
Normal clinical care
Intervention Description
The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)
Description
The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Time Frame
Baseline to End of Study.
Title
Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]
Description
The Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are: 0 to 15 - normal /symptom absent 15 to 20 - mild 21 to 28 - moderate >34 - severe
Time Frame
Baseline to End of Study
Secondary Outcome Measure Information:
Title
The Internal State Scale (ISS) (Bauer et al, 1991)
Description
The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200). The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows: Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania >155 >125 Mixed State >155 <125 Euthymia <155 >125 Depression <155
Time Frame
monthly until October 2011
Title
Global Assessment of Functioning (GAF)
Description
Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.
Time Frame
monthly until October 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible individuals will have experienced their first or second treated episode of mania and / or hypomania in the previous 12-months prior to study entry. Exclusion Criteria: Participants will be excluded if there is a (1) diagnosis of learning disability; (2) inability to participate in psychotherapy/research due to acute medical condition or acute mania
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie D Kirk, D.Clin.Psy
Organizational Affiliation
NHS Greater Glasgow & Clyde / University of Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew I Gumley, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
Facility Information:
Facility Name
Gartnavel Royal Hospital
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
NHS Greater Glasgow & Clyde
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.gla.ac.uk/departments/mentalhealthandwellbeing/biscit/
Description
Study webpage

Learn more about this trial

Bipolar Intervention Study: Cognitive Interpersonal Therapy

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