- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329861
Internet-based Cognitive Behavioural Treatment for Chronic Back Pain
April 5, 2011 updated by: Linkoeping University
Guided Internet-based Cognitive Behavioural Treatment for Chronic Back Pain Reduces Catastrophizing:a Randomized Controlled Trial
The aim of this study was to investigate whether an Internet-based cognitive behavioural intervention would have an effect on the symptoms of chronic back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All participants were screened in a live, structured interview before inclusion.
It´s a experimental design with a treatment and a control group measured before and after a treatment period.
Study Type
Interventional
Enrollment (Actual)
54
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
-
-
-
Uppsala, Sweden
- Uppsala University
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 18-65 years
- access to the Internet
- having been in contact with a physician
- back pain of chronic nature
- in current employment or on short-term sick leave(not longer than 6 months)
Exclusion Criteria:
- wheelchair user
- surgical treatment planned
- history of cardiovascular treatment
- severe depression
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Internet delivered CBT
Internet delivered cognitive behavioral intervention, 8 weeks treatment.
|
Eight weeks internet-based cognitive behavioural treatment.
Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
|
|
No Intervention: Control condition
Wait-list condition, received treatment after post-treatment assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping Strategies Questionnaire - catastrophizing subscale (CSQ)
Time Frame: Two weeks pre treatment to two weeks post treatment
|
Change from baseline in the catastrophizing subscale to two weeks post treatment.
|
Two weeks pre treatment to two weeks post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional Pain Inventory (MPI)
Time Frame: Change from baseline Two weeks pre treatment to two weeks post treatment
|
MPI, assess psychosocial and behavioural consequences of pain.
It´s divided into 2 sections and consisting of 8 scales.
These are: Pain Severity, Interference, Life Control, Affective Distress, Support, Punishing Responses, Solicitous Responses and Distracting Responses.
|
Change from baseline Two weeks pre treatment to two weeks post treatment
|
|
Pain and Impairment Relationship Scale (PAIRS)
Time Frame: Change from baseline Two weeks pre treatment to two weeks post treatment.
|
The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.
|
Change from baseline Two weeks pre treatment to two weeks post treatment.
|
|
Hospital Anxiety and Depression Scale(HADS).
Time Frame: Change from baseline Two weeks pre treatment to two weeks post treatment.
|
HADS is designed to measure anxiety and depression in non-psychiatric patients treated at hospital clinics.
|
Change from baseline Two weeks pre treatment to two weeks post treatment.
|
|
Quality of Life Inventory (QOLI)
Time Frame: Change from baseline Two weeks pre treatment to two weeks post treatment.
|
The assessment yields an overall score and profile for 16 areas of life: health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighbourhood and community.
|
Change from baseline Two weeks pre treatment to two weeks post treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gerhard Andersson, Professor, Linkoeping University
- Principal Investigator: Monica Buhrman, MSc, Uppsala University
- Study Chair: Elisabeth Nilsson-Ihrfelt, MSc, Uppsala University
- Study Chair: Maria Jannert, MSc, Linkoeping University
- Study Chair: Lars Ström, PhD, Livanda (private practice) Västerås
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
June 1, 2004
Primary Completion (Actual)
May 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
April 4, 2011
First Submitted That Met QC Criteria
April 5, 2011
First Posted (Estimate)
April 6, 2011
Study Record Updates
Last Update Posted (Estimate)
April 6, 2011
Last Update Submitted That Met QC Criteria
April 5, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- smarta2011
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.
Clinical Trials on Back Pain Lower Back Chronic
-
Adia Med of Winter Park LLCRecruitingLower Back Pain | Chronic Lower Back Pain | Chronic Mechanical Lower Back PainUnited States
-
Clinique de la Côte d'EmeraudeNot yet recruiting
-
Neuronoff, IncOhio Pain ClinicCompletedChronic Pain | Lower Back Pain ChronicUnited States
-
Texas Back InstituteRecruitingChronic Lower Back PainUnited States
-
New York Institute of TechnologyRecruitingChronic Lower Back PainUnited States
-
Canandaigua VA Medical CenterFoot Levelers, Inc.; Northeast College of Health SciencesTerminatedBack Pain Lower Back ChronicUnited States
-
University of MichiganRecruiting
-
AppliedVR Inc.Completed
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Ondokuz Mayıs UniversityNot yet recruiting
Clinical Trials on Guided Internet-based cognitive behavioural treatment
-
Gerhard AnderssonCompleted
-
Norwegian Institute of Public HealthGöteborg University; University of Bergen; University of Tromso; Sussex Partnership... and other collaboratorsActive, not recruitingAnxiety | Mild to Moderate DepressionNorway
-
Linkoeping UniversityCompleted
-
Karolinska InstitutetRegion StockholmCompletedHypochondriasis | Health Anxiety | Illness Anxiety Disorder | Somatic Symptom Disorder | Severe Health Anxiety | Hypochondriacal Disorder, UnspecifiedSweden
-
Linkoeping UniversityCompletedAdjustment DisordersSweden
-
Karolinska InstitutetRegion StockholmActive, not recruiting
-
Uppsala UniversityLinkoeping University; Utah State University; Friedrich-Alexander-Universität...RecruitingPremenstrual Dysphoric DisorderSweden
-
University of British ColumbiaUnknownDepression | Cardiovascular DiseasesCanada
-
Stockholm UniversityCompletedProcrastinationSweden
-
Centre for Addiction and Mental HealthCompletedGeneralized Anxiety Disorder | Major Depressive Disorder | Social Anxiety Disorder | Panic DisorderCanada