Back Pain Lower Back ChronicNCT01329861
Internet-based Cognitive Behavioural Treatment for Chronic Back Pain
A study testing Guided Internet-based cognitive behavioural treatment in people with Back Pain Lower Back Chronic, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Guided Internet-based cognitive behavioural treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2004to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- wheelchair user
- surgical treatment planned
- history of cardiovascular treatment
- severe depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Guided Internet-based cognitive behavioural treatment
- Keywords
- chronic back pain, internet based treatment, pain management programme, cognitive behavioural therapy, minimal therapist contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Internet-based cognitive behavioural treatmentBehavioural
Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Internet delivered CBT | Experimental | Internet delivered cognitive behavioral intervention, 8 weeks treatment. Receives: Behavioral: Guided Internet-based cognitive behavioural treatment |
| Control condition | No intervention | Wait-list condition, received treatment after post-treatment assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping Strategies Questionnaire - catastrophizing subscale (CSQ)
Change from baseline in the catastrophizing subscale to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Secondary outcomes (4)
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.
Measured: Change from baseline Two weeks pre treatment to two weeks post treatment
Pain and Impairment Relationship Scale (PAIRS)
The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.
Measured: Change from baseline Two weeks pre treatment to two weeks post treatment.
Hospital Anxiety and Depression Scale(HADS).
HADS is designed to measure anxiety and depression in non-psychiatric patients treated at hospital clinics.
Measured: Change from baseline Two weeks pre treatment to two weeks post treatment.
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.
Measured: Change from baseline Two weeks pre treatment to two weeks post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJun 2004
- Primary completionMay 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Uppsala University
- Investigators
- Gerhard Andersson, Professor, Study director, Linkoeping UniversityMonica Buhrman, MSc, Principal investigator, Uppsala UniversityElisabeth Nilsson-Ihrfelt, MSc, Study chair, Uppsala UniversityMaria Jannert, MSc, Study chair, Linkoeping UniversityLars Ström, PhD, Study chair, Livanda (private practice) Västerås
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329861
- Sponsor's protocol ID
- smarta2011
- Status last verified
- Apr 2011
- First submitted
- 4 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-based Cognitive Behavioural Treatment for Chronic Back Pain Reduces Catastrophizing:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01329861
- Acronym / sponsor ID
- smarta2011
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- chronic back pain, internet based treatment, pain management programme, cognitive behavioural therapy, minimal therapist contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Uppsala University
- Study start
- Jun 2004
- Primary completion
- May 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet delivered CBT | Experimental | Behavioral: Guided Internet-based cognitive behavioural treatmentInternet delivered cognitive behavioral intervention, 8 weeks treatment. |
| Control condition | No intervention | –Wait-list condition, received treatment after post-treatment assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- wheelchair user
- surgical treatment planned
- history of cardiovascular treatment
- severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Internet-based cognitive behavioural treatmentEight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance. | Behavioural | Internet delivered CBT |
Primary outcome
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.
4 secondary outcomes
Multidimensional Pain Inventory (MPI)
Time frame: 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.
Hospital Anxiety and Depression Scale(HADS).
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, Professor study director
Linkoeping University
Monica Buhrman, MSc principal investigator
Uppsala University
Elisabeth Nilsson-Ihrfelt, MSc study chair
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Internet-based cognitive behavioural treatment in people with Back Pain Lower Back Chronic, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping Strategies Questionnaire - catastrophizing subscale (CSQ) (time frame: Two weeks pre treatment to two weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.