Clinical Trial: Bipolar Intervention Study: Cognitive Interpersonal Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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?

Sponsor: NHS Greater Glasgow and Clyde

Current Primary Outcome:

  • 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



Original Primary Outcome:

  • Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) [ Time Frame: monthly until October 2011 ]
  • Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] [ Time Frame: monthly until October 2011 ]


Current Secondary Outcome:

  • 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.


Original Secondary Outcome: The Internal State Scale (ISS) (Bauer et al, 1991) [ Time Frame: monthly until October 2011 ]

Information By: NHS Greater Glasgow and Clyde

Dates:
Date Received: March 7, 2011
Date Started: November 2010
Date Completion:
Last Updated: July 29, 2014
Last Verified: April 2014