Clinical trial NCT01315028: Bipolar Intervention Study: Cognitive Interpersonal Therapy
Official title: A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mania
Hypomania
Bipolar Affective Disorder
Keywords: mania
hypomania
bipolar affective disorder
psychological intervention
cognitive therapy
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: University of Glasgow
First posted: 2011-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)
timeFrame: Baseline to End of Study.
measure: Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]
timeFrame: Baseline to End of Study
Secondary outcomes:
measure: The Internal State Scale (ISS) (Bauer et al, 1991)
timeFrame: monthly until October 2011
measure: Global Assessment of Functioning (GAF)
timeFrame: monthly until October 2011
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Gartnavel Royal Hospital
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
Study officials:
affiliation: NHS Greater Glasgow & Clyde / University of Glasgow
name: Jamie D Kirk, D.Clin.Psy
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Andrew I Gumley, PhD
role: STUDY_CHAIR
References: