Chronic PainNCT01491269
Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients
A study testing Guided Internet-based cognitive behavioural treatment in people with Chronic Pain, run by Gerhard Andersson at 1 site in Sweden.
Trial summary
The aim of the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- 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
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Jun 2010
- 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
- to have been medically investigated (within one year)
- completed the multidisciplinary rehabilitation program
- have residual symptoms after the rehabilitation treatment (defined as functional impairment caused by their pain)
- have Internet access
Who cannot join
- planned surgery
- ongoing medical investigation that could impede participation in the study
- suffering from acute physical or psychological conditions
- people confined to wheelchairs
- people not fluent with the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients: Randomised Controlled Trial
The aim of the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems.
Read the detailed description
The present study investigates Internet-delivered CBT as a tertiary intervention. This is motivated by the fact that many pain patients relapse after rehabilitation and some may be in need of additional treatment. The persons who fulfills the inclusion criteria undergoes a structured telephone interview. The study is a experimental design with a treatment and an active control group measured before and after a treatment period. The control group were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.
- Conditions
- Chronic Pain
- Being tested
- Guided Internet-based cognitive behavioural treatment
- Keywords
- chronic pain, internet delivered CBT, tertiary intervention, mindfulness, applied relaxation, guided self help
- Medical subject headings
- Chronic Pain
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 |
| No intervention | No intervention | Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Coping Strategies Questionnaire (CSQ)
The CSQ contains 50 items divided in eight scales that measures different cognitive and behavioral coping strategies. The different coping strategies are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing, increased behavioral activities and pain behavior (Rosenthiel \& Keefe, 1983). Change from baseline in the different subscales pre- and post treatment.
Measured: One week pre treatment, one week post treatment
Secondary outcomes (5)
Hospital Anxiety and Depression Scale, HADS
HADS is a 14-item questionnaire, and is designed to measure anxiety and depression in non-psychiatric patients.
Measured: One week pre treatment, one week post treatment
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: One week pre treatment, one week post treatment
Pain and Impairment Relationship Scale (PAIRS)
PAIRS consist of 15 personal statements that reflect thoughts, attitudes and opinions about pain. The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.
Measured: One week pre treatment, one week post treatment
Quality of Life Inventory (QOLI)
QOLI contains 32 items for assessing life satisfaction. The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood and community. Each item is rated in terms of importance and satisfaction.
Measured: One week pre treatment, one week post after treatment
Chronic Pain Acceptance Questionnaire (CPAQ)
CPAQ contains 20 items divided in two scales, engagement and willingness. CPAQ measures acceptance in relation to chronic pain.
Measured: One week pre treatment, one week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerhard Andersson
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Professor, Study director, Linkoeping UniversityMonica Buhrman, MSc, Principal investigator, Uppsala UniversityTimo Hursti, PhD, Study chair, Uppsala UniversityTorsten Gordh, Professor, Study chair, Uppsala UniversityAnna Fredriksson, MSc, Study chair, Uppsala UniversityGunnel Edström, MSc, Study chair, Uppsala UniversityDorna Shaffi, MSc, Study chair, Uppsala UniversityCarolina Törnqvist, MSc, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491269
- Sponsor's protocol ID
- smartaMB2011
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2011
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01491269
- Acronym / sponsor ID
- smartaMB2011
- Conditions
- Chronic Pain
- Keywords
- chronic pain, internet delivered CBT, tertiary intervention, mindfulness, applied relaxation, guided self help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gerhard AnderssonOther government
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Dec 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 the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems.
Detailed description
The present study investigates Internet-delivered CBT as a tertiary intervention. This is motivated by the fact that many pain patients relapse after rehabilitation and some may be in need of additional treatment. The persons who fulfills the inclusion criteria undergoes a structured telephone interview. The study is a experimental design with a treatment and an active control group measured before and after a treatment period. The control group were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.
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. |
| No intervention | No intervention | –Waitlist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- to have been medically investigated (within one year)
- completed the multidisciplinary rehabilitation program
- have residual symptoms after the rehabilitation treatment (defined as functional impairment caused by their pain)
- have Internet access
Key exclusion criteria (5 listed)
- planned surgery
- ongoing medical investigation that could impede participation in the study
- suffering from acute physical or psychological conditions
- people confined to wheelchairs
- people not fluent with the Swedish language
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
The Coping Strategies Questionnaire (CSQ)
Time frame: One week pre treatment, one week post treatment
The CSQ contains 50 items divided in eight scales that measures different cognitive and behavioral coping strategies. The different coping strategies are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing, increased behavioral activities and pain behavior (Rosenthiel \& Keefe, 1983). Change from baseline in the different subscales pre- and post treatment.
5 secondary outcomes
Hospital Anxiety and Depression Scale, HADS
Time frame: One week pre treatment, one week post treatment
Multidimensional Pain Inventory, MPI
Time frame: One week pre treatment, one week post treatment
Pain and Impairment Relationship Scale (PAIRS)
Time frame: One week pre treatment, one week post treatment
Quality of Life Inventory (QOLI)
Time frame: One week pre treatment, one week post after treatment
Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: One week pre treatment, one week 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 14 Dec 2023.
- Individual participant dataSharing planned: No
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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
Timo Hursti, PhD 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 Chronic Pain, run by Gerhard Andersson 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 4 inclusion and 5 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 14 Dec 2023. 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?
The Coping Strategies Questionnaire (CSQ) (time frame: One week pre treatment, one week 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 14 Dec 2023.