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

May 2, 2013 updated by: Fredrik Holländare, Örebro County Council

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 701 16
        • Psychiatric Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Guided internet-based cognitive behavior therapy (CBT)
Behavioral: Guided internet-based cognitive behavior therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro County Council

Collaborators

School of Law, Psychology and Social Work, Örebro University

Investigators

  • Principal Investigator: Fredrik Holländare, PhD, School of Health and Medical Science, Psychiatric Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (ESTIMATE)

December 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39:2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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