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Internet-based Cognitive Behavioural Treatment for Chronic Back Pain

Primary Purpose

Back Pain Lower Back Chronic

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Guided Internet-based cognitive behavioural treatment

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring chronic back pain, internet based treatment, pain management programme, cognitive behavioural therapy, minimal therapist contact

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet delivered CBT

Control condition

Arm Description

Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Wait-list condition, received treatment after post-treatment assessment.

Outcomes

Primary Outcome Measures

Coping Strategies Questionnaire - catastrophizing subscale (CSQ)

Change from baseline in the catastrophizing subscale to two weeks post treatment.

Secondary Outcome Measures

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.

Pain and Impairment Relationship Scale (PAIRS)

The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.

Hospital Anxiety and Depression Scale(HADS).

HADS is designed to measure anxiety and depression in non-psychiatric patients treated at hospital clinics.

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.

Full Information

NCT ID

NCT01329861

First Posted

April 4, 2011

Last Updated

April 5, 2011

Sponsor

Linkoeping University

Collaborators

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT01329861

Brief Title

Internet-based Cognitive Behavioural Treatment for Chronic Back Pain

Official Title

Guided Internet-based Cognitive Behavioural Treatment for Chronic Back Pain Reduces Catastrophizing:a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Linkoeping University

Collaborators

Uppsala University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

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

Back Pain Lower Back Chronic

Keywords

chronic back pain, internet based treatment, pain management programme, cognitive behavioural therapy, minimal therapist contact

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet delivered CBT

Arm Type

Experimental

Arm Description

Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Arm Title

Control condition

Arm Type

No Intervention

Arm Description

Wait-list condition, received treatment after post-treatment assessment.

Intervention Type

Behavioral

Intervention Name(s)

Guided Internet-based cognitive behavioural treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Coping Strategies Questionnaire - catastrophizing subscale (CSQ)

Description

Change from baseline in the catastrophizing subscale to two weeks post treatment.

Time Frame

Two weeks pre treatment to two weeks post treatment

Secondary Outcome Measure Information:

Title

Multidimensional Pain Inventory (MPI)

Description

Time Frame

Change from baseline Two weeks pre treatment to two weeks post treatment

Title

Pain and Impairment Relationship Scale (PAIRS)

Description

The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.

Time Frame

Change from baseline Two weeks pre treatment to two weeks post treatment.

Title

Hospital Anxiety and Depression Scale(HADS).

Description

HADS is designed to measure anxiety and depression in non-psychiatric patients treated at hospital clinics.

Time Frame

Change from baseline Two weeks pre treatment to two weeks post treatment.

Title

Quality of Life Inventory (QOLI)

Description

Time Frame

Change from baseline Two weeks pre treatment to two weeks post treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: