Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II

Bipolar Disorder, Type II Clinical Trial

Official title:

Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742351
• Other study ID #: 39:2012
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: May 2, 2013
• Start date: January 2013
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of bipolar disorder type II

• Mild to moderate depressive symptoms

• 18 years of age

• Stable medication with a mood stabiliser

• Access to the internet

Exclusion Criteria:

• Diagnosis of psychosis

• Having received psychiatric in-patient care during the past year

• Ongoing psychotherapy

• Previous manic episode

• Previous suicide attempt

• Previous parasuicidal behavior documented in patient record (e.g. self-injury)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder, Type II

Intervention

Behavioral:
• Guided internet-based cognitive behavior therapy

Locations

Country	Name	City	State
Sweden	Psychiatric Research Centre	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro County Council	School of Law, Psychology and Social Work, Örebro University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment	A nine item questionnaire of depressive symptoms	9 weeks
Secondary	Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment	A nine item subscale of the AS-18 measuring symptoms of mania/hypomania.	9 weeks