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

Primary Purpose

Bipolar Disorder, Type II

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Guided internet-based cognitive behavior therapy
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder, Type II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Psychiatric Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guided internet-based cognitive behavior therapy (CBT)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 16, 2012
Last Updated
May 2, 2013
Sponsor
Örebro County Council
Collaborators
School of Law, Psychology and Social Work, Örebro University
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1. Study Identification

Unique Protocol Identification Number
NCT01742351
Brief Title
Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II
Official Title
Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
School of Law, Psychology and Social Work, Örebro University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Type II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided internet-based cognitive behavior therapy (CBT)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Guided internet-based cognitive behavior therapy
Primary Outcome Measure Information:
Title
Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment
Description
A nine item questionnaire of depressive symptoms
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment
Description
A nine item subscale of the AS-18 measuring symptoms of mania/hypomania.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Holländare, PhD
Organizational Affiliation
School of Health and Medical Science, Psychiatric Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Research Centre
City
Örebro
ZIP/Postal Code
701 16
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25908235
Citation
Hollandare F, Eriksson A, Lovgren L, Humble MB, Boersma K. Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study. JMIR Res Protoc. 2015 Apr 23;4(2):e44. doi: 10.2196/resprot.3910.
Results Reference
derived

Learn more about this trial

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

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