Bipolar Intervention Study: Cognitive Interpersonal Therapy

Mania Clinical Trial

— BISCIT  

Official title:

A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315028
• Other study ID #: GN09CP546
• Secondary ID: CZG/2/472
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: July 29, 2014
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2014
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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:

1. Population: could appropriate individuals be identified and recruited to a trial of CIT for early bipolar disorder?

2. 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?

3. 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?

4. Outcomes: which outcomes are appropriate for measuring relevant dimensions of a treatment effect?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Genetic Diseases, X-Linked
• Hypomania
• Mania
• Mood Disorders

Intervention

Other:
• Cognitive Interpersonal Therapy
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).
• Treatment As Usual
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.

Locations

Country	Name	City	State
United Kingdom	Gartnavel Royal Hospital	Glasgow	Lanarkshire
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Chief Scientist Office of the Scottish Government, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to End of Study.	No
Primary	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	Baseline to End of Study	No
Secondary	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	monthly until October 2011	No
Secondary	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.	monthly until October 2011	No

External Links

•   Study webpage