Bipolar Intervention Study: Cognitive Interpersonal Therapy (BISCIT)
This study is currently recruiting participants.
Verified December 2011 by NHS Greater Glasgow and Clyde
Sponsor:
NHS Greater Glasgow and Clyde
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
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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 May 21, 2013