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Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Internet-based CBT

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

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

Inclusion Criteria:

Current diagnosis of fibromyalgia

Exclusion Criteria:

Current diagnosis of severe psychiatric disorder

Sites / Locations

Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-based CBT

Arm Description

Outcomes

Primary Outcome Measures

The Fibromyalgia Impact Questionnaire

Secondary Outcome Measures

Short form 12-item Questionnaire

Hospital Anxiety and Depression Scale

Full Information

NCT ID

NCT01468961

First Posted

November 8, 2011

Last Updated

August 17, 2017

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01468961

Brief Title

Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Official Title

Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. Participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet-based CBT

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Internet-based CBT

Intervention Description

10 weeks of internet-based CBT with online therapist contact

Primary Outcome Measure Information:

Title

The Fibromyalgia Impact Questionnaire

Time Frame

Once, 1 week before start of treatment

Title

The Fibromyalgia Impact Questionnaire

Time Frame

Once, immediately after treatment

Title

The Fibromyalgia Impact Questionnaire

Time Frame

Once, 6 months after treatment

Secondary Outcome Measure Information:

Title

Short form 12-item Questionnaire

Time Frame

Once, 1 week before start of treatment

Title

Short form 12-item Questionnaire

Time Frame

Once, immediately after treatment

Title

Short form 12-item Questionnaire

Time Frame

Once, 6 months after treatment

Title

Hospital Anxiety and Depression Scale

Time Frame

Once, 1 week before start of treatment

Title

Hospital Anxiety and Depression Scale

Time Frame

Once, immediately after treatment

Title

Hospital Anxiety and Depression Scale

Time Frame

Once, 6 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current diagnosis of fibromyalgia Exclusion Criteria: Current diagnosis of severe psychiatric disorder

Facility Information:

Facility Name

Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24215278

Citation

Ljotsson B, Atterlof E, Lagerlof M, Andersson E, Jernelov S, Hedman E, Kemani M, Wicksell RK. Internet-delivered acceptance and values-based exposure treatment for fibromyalgia: a pilot study. Cogn Behav Ther. 2014;43(2):93-104. doi: 10.1080/16506073.2013.846401. Epub 2013 Nov 12.

Results Reference

result

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Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

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