Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)

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

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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