Bipolar Intervention Study: Cognitive Interpersonal Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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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).

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Detailed Description

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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?

Conditions

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Mania Hypomania Bipolar Affective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Cognitive Interpersonal Therapy

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Psychological Therapy Normal clinical care

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No