Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)

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NHS Trust

Status

Completed

Conditions

Bipolar Affective Disorder
Mania
Hypomania

Treatments

Other: Cognitive Interpersonal Therapy
Other: Treatment As Usual

Study type

Interventional

Funder types

Other

Identifiers

NCT01315028
GN09CP546
CZG/2/472 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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: Population: could appropriate individuals be identified and recruited to a trial of CIT for early bipolar disorder? 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? 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? Outcomes: which outcomes are appropriate for measuring relevant dimensions of a treatment effect?

Enrollment

20 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Psychological Therapy
Experimental group
Description:
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).
Treatment:
Other: Cognitive Interpersonal Therapy
Treatment As Usual
Active Comparator group
Description:
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.
Treatment:
Other: Treatment As Usual

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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