Bipolar Intervention Study: Cognitive Interpersonal Therapy

NCT01315028 | Completed Results DMC

• 2 other identifiers: GN09CP546CZG/2/472
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Mania; Hypomania; Bipolar Affective Disorder

Keywords

mania; hypomania; bipolar affective disorder; psychological intervention; cognitive therapy

Outcome Measures

Primary Outcomes (2)

• Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)

  The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

  Baseline to End of Study.

• Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]

  The Bech-Rafaelsen Mania Rating Scale (BRMS) \[Bech et al, 1979\] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are: 0 to 15 - normal /symptom absent 15 to 20 - mild 21 to 28 - moderate \>34 - severe

  Baseline to End of Study

Secondary Outcomes (2)

• The Internal State Scale (ISS) (Bauer et al, 1991)

  monthly until October 2011

• Global Assessment of Functioning (GAF)

  monthly until October 2011

Study Arms (2)

Psychological Therapy

EXPERIMENTAL

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).

Other: Cognitive Interpersonal Therapy

Treatment As Usual

ACTIVE COMPARATOR

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.

Other: Treatment As Usual

Interventions

Cognitive Interpersonal Therapy 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).

Also known as: Psychological Therapy

Psychological Therapy

Treatment As Usual 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.

Also known as: Normal clinical care

Treatment As Usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Chief Scientist Office of the Scottish Government: collaborator
• University of Glasgow: collaborator

Study Sites (2)

Gartnavel Royal Hospital

Glasgow, Lanarkshire, G12 0XH, United Kingdom

Location

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

Related Links

• Study webpage

MeSH Terms

Conditions

Mania; Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

A definitive clinical trial should incorporate an appropriate sample size, incorporate more than one therapist, assess fidelity and competence in therapy delivery and also include measurements of health economic dimensions of outcome.

Results Point of Contact

• Title: Professor Andrew Gumley
• Organization: University of Glasgow

andrew.gumley@glasgow.ac.uk

0044 141 211 3927

Study Officials

• Jamie D Kirk, D.Clin.Psy

  NHS Greater Glasgow & Clyde / University of Glasgow

  PRINCIPAL INVESTIGATOR

• Andrew I Gumley, PhD

  University of Glasgow

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist / Chief Investigator

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 15, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 30, 2014
• Results First Posted: July 30, 2014

Record last verified: 2014-04

Locations

GB (2)