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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01329861
Other study ID # smarta2011
Secondary ID
Status Completed
Phase N/A
First received April 4, 2011
Last updated April 5, 2011
Start date June 2004
Est. completion date August 2005

Study information

Verified date April 2011
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date August 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Guided Internet-based cognitive behavioural treatment
Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.

Locations

Country Name City State
Sweden Uppsala University Uppsala

Sponsors (2)

Lead Sponsor Collaborator
Linkoeping University Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coping Strategies Questionnaire - catastrophizing subscale (CSQ) Change from baseline in the catastrophizing subscale to two weeks post treatment. Two weeks pre treatment to two weeks post treatment No
Secondary Multidimensional Pain Inventory (MPI) 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 No
Secondary Pain and Impairment Relationship Scale (PAIRS) 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. No
Secondary Hospital Anxiety and Depression Scale(HADS). 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. No
Secondary Quality of Life Inventory (QOLI) 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. No
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