Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)

This study has been completed.
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
University of Glasgow
Information provided by (Responsible Party):
Jamie Kirk, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01315028
First received: March 7, 2011
Last updated: July 29, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Mania
Hypomania
Bipolar Affective Disorder
Other: Cognitive Interpersonal Therapy
Other: Treatment As Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) [ Time Frame: Baseline to End of Study. ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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) [ Time Frame: monthly until October 2011 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  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?
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315028

Locations
United Kingdom
Gartnavel Royal Hospital
Glasgow, Lanarkshire, United Kingdom, G12 0XH
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
University of Glasgow
Investigators
Principal Investigator: Jamie D Kirk, D.Clin.Psy NHS Greater Glasgow & Clyde / University of Glasgow
Study Chair: Andrew I Gumley, PhD University of Glasgow
  More Information

Additional Information:
No publications provided

Responsible Party: Jamie Kirk, Clinical Psychologist / Chief Investigator, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01315028     History of Changes
Other Study ID Numbers: GN09CP546, CZG/2/472
Study First Received: March 7, 2011
Results First Received: November 11, 2013
Last Updated: July 29, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
mania
hypomania
bipolar affective disorder
psychological intervention
cognitive therapy

Additional relevant MeSH terms:
Bipolar Disorder
Genetic Diseases, X-Linked
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 21, 2014