Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)
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|ClinicalTrials.gov Identifier: NCT01315028|
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : July 30, 2014
Last Update Posted : July 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mania Hypomania Bipolar Affective Disorder||Other: Cognitive Interpersonal Therapy Other: Treatment As Usual||Not Applicable|
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?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Psychological Therapy
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).
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).
Other Name: Psychological Therapy
Active Comparator: Treatment As Usual
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.
Other: 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.
Other Name: Normal clinical care
- Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) [ Time Frame: Baseline to End of Study. ]
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] [ Time Frame: Baseline to End of Study ]
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
- The Internal State Scale (ISS) (Bauer et al, 1991) [ Time Frame: monthly until October 2011 ]
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) [ Time Frame: monthly until October 2011 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315028
|Gartnavel Royal Hospital|
|Glasgow, Lanarkshire, United Kingdom, G12 0XH|
|NHS Greater Glasgow & Clyde|
|Glasgow, United Kingdom|
|Principal Investigator:||Jamie D Kirk, D.Clin.Psy||NHS Greater Glasgow & Clyde / University of Glasgow|
|Study Chair:||Andrew I Gumley, PhD||University of Glasgow|