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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
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
University of Glasgow
Information provided by (Responsible Party):
Jamie Kirk, NHS Greater Glasgow and Clyde

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mania
Hypomania
Bipolar Affective Disorder
Interventions Other: Cognitive Interpersonal Therapy
Other: Treatment As Usual
Enrollment 20
Recruitment Details Participants were consecutively recruited from mental health services within the Glasgow. A total of 32 patients were referred to the study during the 9-month recruitment window between November 2010 and July 2011 (3.5 referrals/month). Of the 32 patients referred 23 consented to participate in the trial. This equates to a consent rate of 71.88%.
Pre-assignment Details Of the 32 individuals referred, 6 were not assessed as: 3 refused consent, 2 were unable to be contacted within recruitment window and 1 individual moved away from the study location. A further three individuals did not meet our inclusion criteria.
Arm/Group Title Psychological Therapy Treatment As Usual
Hide Arm/Group Description 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). Normal Clinical Care : 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.
Period Title: Overall Study
Started 10 10
Completed 9 9
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Death             0             1
Arm/Group Title Psychological Therapy Treatment As Usual Total
Hide Arm/Group Description 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). Normal Clinical Care : 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. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
1
  10.0%
1
   5.0%
Between 18 and 65 years
9
  90.0%
9
  90.0%
18
  90.0%
>=65 years
1
  10.0%
0
   0.0%
1
   5.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
33.40  (6.90) 41.60  (45.50) 37.5  (12.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
7
  70.0%
7
  70.0%
14
  70.0%
Male
3
  30.0%
3
  30.0%
6
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychological Therapy Treatment As Usual
Hide Arm/Group Description:
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).
Normal Clinical Care : 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.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 26.20  (12.12) 20.20  (13.92)
End of Study 16.11  (11.82) 15.22  (16.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psychological Therapy, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychological Therapy Treatment As Usual
Hide Arm/Group Description:
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).
Normal Clinical Care : 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.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.00  (7.76) 6.70  (4.42)
End of Study 4.78  (4.55) 4.11  (5.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psychological Therapy, Treatment As Usual
Comments Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title The Internal State Scale (ISS) (Bauer et al, 1991)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychological Therapy Treatment As Usual
Hide Arm/Group Description:
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).
Normal Clinical Care : 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.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
ISS - Perceived Conflict (Baseline) 126.00  (94.78) 78.00  (62.32)
ISS - Well-being (Baseline) 97.00  (63.08) 181.00  (53.84)
ISS - Activation (Baseline) 122.00  (81.89) 114.00  (86.31)
ISS - Depression (Baseline) 76.00  (68.02) 41.00  (50.21)
ISS - Perceived Conflict (End of Study) 142.00  (94.84) 94.44  (105.37)
ISS - Well-being (End of Study) 127.78  (67.97) 137.78  (82.73)
ISS - Activation (End of Study) 131.11  (108.45) 113.33  (117.69)
ISS - Depression (End of Study) 46.64  (47.17) 45.56  (57.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psychological Therapy, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Global Assessment of Functioning (GAF)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychological Therapy Treatment As Usual
Hide Arm/Group Description:
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).
Normal Clinical Care : 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.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 57.90  (20.40) 60.90  (10.37)
End of Study 72.00  (14.05) 70.56  (16.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psychological Therapy, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Psychological Therapy Treatment As Usual
Hide Arm/Group Description 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). Normal Clinical Care : 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.
All-Cause Mortality
Psychological Therapy Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Psychological Therapy Treatment As Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      2/10 (20.00%)    
Psychiatric disorders     
Suicide * [1]  0/10 (0.00%)  0 1/10 (10.00%)  1
Admission to psychiatric Hospital * [2]  0/10 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One participant randomized to TAU completed suicide
[2]
One participant randomized to TAU group was admitted to psychiatric hospital.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Psychological Therapy Treatment As Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
A definitive clinical trial should incorporate an appropriate sample size, incorporate more than one therapist, assess fidelity and competence in therapy delivery and also include measurements of health economic dimensions of outcome.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Andrew Gumley
Organization: University of Glasgow
Phone: 0044 141 211 3927
EMail: andrew.gumley@glasgow.ac.uk
Layout table for additonal information
Responsible Party: Jamie Kirk, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01315028     History of Changes
Other Study ID Numbers: GN09CP546
CZG/2/472 ( Other Grant/Funding Number: Chief Scientist Office, Scottish Executive )
First Submitted: March 7, 2011
First Posted: March 15, 2011
Results First Submitted: November 11, 2013
Results First Posted: July 30, 2014
Last Update Posted: July 30, 2014