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

This study has been completed.
Sponsor:
Collaborator:
School of Law, Psychology and Social Work, Örebro University
Information provided by (Responsible Party):
Fredrik Holländare, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01742351
First received: November 16, 2012
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Bipolar Disorder, Type II
Behavioral: Guided internet-based cognitive behavior therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment [ Time Frame: 9 weeks ]
    A nine item questionnaire of depressive symptoms


Secondary Outcome Measures:
  • Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment [ Time Frame: 9 weeks ]
    A nine item subscale of the AS-18 measuring symptoms of mania/hypomania.


Enrollment: 7
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided internet-based cognitive behavior therapy (CBT) Behavioral: Guided internet-based cognitive behavior therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742351

Locations
Sweden
Psychiatric Research Centre
Örebro, Sweden, 701 16
Sponsors and Collaborators
Örebro County Council
School of Law, Psychology and Social Work, Örebro University
Investigators
Principal Investigator: Fredrik Holländare, PhD School of Health and Medical Science, Psychiatric Research Centre
  More Information

No publications provided

Responsible Party: Fredrik Holländare, Psychologist, PhD, Örebro County Council
ClinicalTrials.gov Identifier: NCT01742351     History of Changes
Other Study ID Numbers: 39:2012
Study First Received: November 16, 2012
Last Updated: May 2, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on September 30, 2014