Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by NHS Greater Glasgow and Clyde.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
University of Glasgow
Information provided by (Responsible Party):
Jamie Kirk, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01315028
First received: March 7, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention
Mania
Hypomania
Bipolar Affective Disorder
Other: Cognitive Interpersonal Therapy
Other: Normal Clinical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) [ Time Frame: monthly until October 2011 ] [ Designated as safety issue: No ]
  • Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] [ Time Frame: monthly until October 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Internal State Scale (ISS) (Bauer et al, 1991) [ Time Frame: monthly until October 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological Therapy Other: 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).
Other Name: Psychological Therapy
Active Comparator: Treatment As Usual Other: Normal Clinical Care
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.
Other Name: Treatment as usual

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315028

Locations
United Kingdom
Gartnavel Royal Hospital Completed
Glasgow, Lanarkshire, United Kingdom, G12 0XH
NHS Greater Glasgow & Clyde Recruiting
Glasgow, United Kingdom
Contact: Jamie D Kirk, DClinPsych       jamie.kirk@nhs.net   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
University of Glasgow
Investigators
Principal Investigator: Jamie D Kirk, D.Clin.Psy NHS Greater Glasgow & Clyde / University of Glasgow
Study Chair: Andrew I Gumley, PhD University of Glasgow
  More Information

Additional Information:
No publications provided

Responsible Party: Jamie Kirk, Clinical Psychologist / Chief Investigator, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01315028     History of Changes
Other Study ID Numbers: GN09CP546, CZG/2/472
Study First Received: March 7, 2011
Last Updated: December 6, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
mania
hypomania
bipolar affective disorder
psychological intervention
cognitive therapy

Additional relevant MeSH terms:
Bipolar Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014