Chronic PainTIPPSNCT03316846
Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress
A study testing Internet-Delivered Cognitive Behavioral Therapy in people with Chronic Pain and Depressive Symptoms, run by Uppsala University at 1 site in Sweden.
Trial summary
This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Chronic Pain, Depressive Symptoms, Anxiety
- What is being tested?
- Internet-Delivered Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteSweden
- Study dates
- 13 Sep 2016to Dec 2018
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Experienced pain for at least the three previous months
- Medically evaluated regarding the pain condition
- Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
- Access to, and ability to use, a personal computer with internet access
- Mastery of the swedish language
Who cannot join
- Currently undergoing or planning to undergo CBT-treatment during the course of the study
- Currently undergoing or planning to undergo major changes in pharmacotherapy during the course of the study, or have made such changes in the last 2 months
- Have planned surgical intervention during the course of the study
- Currently experiencing symptoms of severe depression (scores >16 on suicidality on M.I.N.I.)
- Currently experiencing significant symptoms of psychosis (fulfills M.I.N.I criteria for psychotic syndrome, current)
- Currently experiencing significant symptoms of alcohol or substance abuse (fulfills M.I.N.I criteria for alcohol- or substance use disorder)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychology, Uppsala University
Uppsala, Uppland, 75236
About this study
Official title: Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress
This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. After the first group has received treatment, the same program will be offered to participants in the control group. Treatment will be tailored on the level of individual participants, enabling individuals suffering a wide range of problems to be recruited. The treatment will consist of a 10-week guided self-help program, followed by a booster program and follow-up one year later. During the curse of the treatment the participants will be guided via text communication by a licensed psychologist or a candidate psychologist on their last year of studies.
The primary hypothesis is that an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric distress. The investigators expect that patients in the treatment group will show reduced levels of disability, depression and anxiety, while improving on scales measuring coping and quality of life.
Read the detailed description
Patients suffering from chronic pain often experience comorbid psychiatric distress. Cognitive behavioral therapy (CBT) has been shown to be effective in treating both these problems. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering CBT though the internet (iCBT) is a novel approach, sidestepping logistical issues while lowering costs. This however, is an area were research is lacking, and though there are several studies showing iCBT to be efficacious in treating both pain and psychiatric conditions, research on a combined approach is scarce.
This study will primarily investigate whether an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric conditions. The project will also clarify whether a following booster-program, also administered tough the internet, is helpful in maintaining and increasing effects of the initial treatment. Lastly, analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.
The treatment will be based on a previously developed program, devised to target depression and anxiety in patients with chronic pain. The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using CBT techniques. The treatment includes modules addressing depression, anxiety, panic, worry, insomnia, stress, trauma, communication skills, and relaxation. The booster program will be based on the initial treatment, but will shorter, focusing on repetition, strategies for maintenance, and coping with setbacks. The platform used is an existing platform employed by Smärtcentrum at Uppsala university hospital for delivering internet based treatments.
The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iCBT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. Participants will assessed by a licensed psychologist, and treatment modules assigned based on their individual needs. In addition to online CBT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologist or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.
- Conditions
- Chronic Pain, Depressive Symptoms, Anxiety, Stress, Psychological
- Being tested
- Internet-Delivered Cognitive Behavioral Therapy
- Keywords
- Chronic Pain, Depression, Anxiety, Stress, iCBT, Cognitive behavioral therapy, Internet delivered, Tailored treatment
- Medical subject headings
- Chronic Pain, Depression, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Delivered Cognitive Behavioral TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered therapy | Experimental | 10 week, guided and individually tailored internet-delivered cognitive behavioral therapy. Receives: Behavioral: Internet-Delivered Cognitive Behavioral Therapy |
| Wait list control group | No intervention | Wait list control group, receives treatment at later point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Measured: at 10 weeks
Change from baseline in depressive symptoms
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Measured: at one-year
Change from baseline in psychosocial consequences of pain
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Measured: at 10 weeks
Change from baseline in psychosocial consequences of pain
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Measured: at one-year
Secondary outcomes (30)
Change from baseline in anxiety sensitivity
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
Measured: at 10 weeks
Change from baseline in anxiety sensitivity
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
Measured: at one-year
Change from baseline in symptoms of depression and anxiety
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
Measured: at 10 weeks
Change from baseline in symptoms of depression and anxiety
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
Measured: at one-year
Change from baseline in pain disability
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
Measured: at 10 weeks
Change from baseline in pain disability
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
Measured: at one-year
Change from baseline in quality of life
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
Measured: at 10 weeks
Change from baseline in quality of life
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
Measured: at one-year
Fear of pain due to movement
Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
Measured: Baseline only
Change from baseline in insomnia symptoms
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
Measured: at 10 weeks
Change from baseline in insomnia symptoms
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
Measured: at one-year
Change from baseline in PTSD symptoms
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
Measured: at 10 weeks
Change from baseline in PTSD symptoms
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
Measured: at one-year
Change from baseline in stress
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
Measured: at 10 weeks
Change from baseline in stress
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
Measured: at one-year
Change from baseline in GAD-symptoms
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
Measured: at 10 weeks
Change from baseline in GAD-symptoms
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
Measured: at one-year
Change from baseline in pain catastrophizing
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Measured: at 5 weeks
Change from baseline in pain catastrophizing
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Measured: at 10 weeks
Change from baseline in pain catastrophizing
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Measured: at one-year
Change from baseline in coping strategies
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Measured: at one-year
Change from baseline in coping strategies
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Measured: at 5 weeks
Change from baseline in coping strategies
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Measured: at 10 weeks
Change from baseline in pain acceptance
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Measured: at 5 weeks
Change from baseline in pain acceptance
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Measured: at 10 weeks
Change from baseline in pain acceptance
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Measured: at one-year
Change from baseline in self efficacy
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Measured: at 5 weeks
Change from baseline in self efficacy
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Measured: at 10 weeks
Change from baseline in self efficacy
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Measured: at one-year
Treatment credibility rating
Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start13 Sep 2016
- Primary completionMay 2017
- Study completionDec 2018
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.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Monica Buhrman, PhD, Study director, Uppsala UniversityGerhard Andersson, Professor, Study chair, Linkoeping UniversityTorsten Gordh, Professor, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316846
- Sponsor's protocol ID
- 140371
- Acronym
- TIPPS
- Status last verified
- May 2020
- First submitted
- 1 Sep 2017
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress
- ClinicalTrials.gov ID
- NCT03316846
- Acronym / sponsor ID
- TIPPS / 140371
- Conditions
- Chronic Pain, Depressive Symptoms, Anxiety, Stress, Psychological
- Keywords
- Chronic Pain, Depression, Anxiety, Stress, iCBT, Cognitive behavioral therapy, Internet delivered, Tailored treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- 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.
This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. After the first group has received treatment, the same program will be offered to participants in the control group. Treatment will be tailored on the level of individual participants, enabling individuals suffering a wide range of problems to be recruited. The treatment will consist of a 10-week guided self-help program, followed by a booster program and follow-up one year later. During the curse of the treatment the participants will be guided via text communication by a licensed psychologist or a candidate psychologist on their last year of studies.
The primary hypothesis is that an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric distress. The investigators expect that patients in the treatment group will show reduced levels of disability, depression and anxiety, while improving on scales measuring coping and quality of life.
Detailed description
Patients suffering from chronic pain often experience comorbid psychiatric distress. Cognitive behavioral therapy (CBT) has been shown to be effective in treating both these problems. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering CBT though the internet (iCBT) is a novel approach, sidestepping logistical issues while lowering costs. This however, is an area were research is lacking, and though there are several studies showing iCBT to be efficacious in treating both pain and psychiatric conditions, research on a combined approach is scarce.
This study will primarily investigate whether an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric conditions. The project will also clarify whether a following booster-program, also administered tough the internet, is helpful in maintaining and increasing effects of the initial treatment. Lastly, analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.
The treatment will be based on a previously developed program, devised to target depression and anxiety in patients with chronic pain. The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using CBT techniques. The treatment includes modules addressing depression, anxiety, panic, worry, insomnia, stress, trauma, communication skills, and relaxation. The booster program will be based on the initial treatment, but will shorter, focusing on repetition, strategies for maintenance, and coping with setbacks. The platform used is an existing platform employed by Smärtcentrum at Uppsala university hospital for delivering internet based treatments.
The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iCBT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. Participants will assessed by a licensed psychologist, and treatment modules assigned based on their individual needs. In addition to online CBT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologist or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered therapy | Experimental | Behavioral: Internet-Delivered Cognitive Behavioral Therapy10 week, guided and individually tailored internet-delivered cognitive behavioral therapy. |
| Wait list control group | No intervention | –Wait list control group, receives treatment at later point. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Experienced pain for at least the three previous months
- Medically evaluated regarding the pain condition
- Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
- Access to, and ability to use, a personal computer with internet access
- Mastery of the swedish language
Key exclusion criteria (6 listed)
- Currently undergoing or planning to undergo CBT-treatment during the course of the study
- Currently undergoing or planning to undergo major changes in pharmacotherapy during the course of the study, or have made such changes in the last 2 months
- Have planned surgical intervention during the course of the study
- Currently experiencing symptoms of severe depression (scores >16 on suicidality on M.I.N.I.)
- Currently experiencing significant symptoms of psychosis (fulfills M.I.N.I criteria for psychotic syndrome, current)
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 |
|---|---|---|
| Internet-Delivered Cognitive Behavioral Therapy | Behavioural | Internet-delivered therapy |
Primary outcome
Change from baseline in depressive symptoms
Time frame: at 10 weeks
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Change from baseline in depressive symptoms
Time frame: at one-year
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Change from baseline in psychosocial consequences of pain
Time frame: at 10 weeks
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Change from baseline in psychosocial consequences of pain
Time frame: at one-year
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
30 secondary outcomes
Change from baseline in anxiety sensitivity
Time frame: at 10 weeks
Change from baseline in anxiety sensitivity
Time frame: at one-year
Change from baseline in symptoms of depression and anxiety
Time frame: at 10 weeks
Change from baseline in symptoms of depression and anxiety
Time frame: at one-year
Change from baseline in pain disability
Time frame: at 10 weeks
Change from baseline in pain disability
Time frame: at one-year
Change from baseline in quality of life
Time frame: at 10 weeks
Change from baseline in quality of life
Time frame: at one-year
Fear of pain due to movement
Time frame: Baseline only
Change from baseline in insomnia symptoms
Time frame: at 10 weeks
Change from baseline in insomnia symptoms
Time frame: at one-year
Change from baseline in PTSD symptoms
Time frame: at 10 weeks
Change from baseline in PTSD symptoms
Time frame: at one-year
Change from baseline in stress
Time frame: at 10 weeks
Change from baseline in stress
Time frame: at one-year
Change from baseline in GAD-symptoms
Time frame: at 10 weeks
Change from baseline in GAD-symptoms
Time frame: at one-year
Change from baseline in pain catastrophizing
Time frame: at 5 weeks
Change from baseline in pain catastrophizing
Time frame: at 10 weeks
Change from baseline in pain catastrophizing
Time frame: at one-year
Change from baseline in coping strategies
Time frame: at one-year
Change from baseline in coping strategies
Time frame: at 5 weeks
Change from baseline in coping strategies
Time frame: at 10 weeks
Change from baseline in pain acceptance
Time frame: at 5 weeks
Change from baseline in pain acceptance
Time frame: at 10 weeks
Change from baseline in pain acceptance
Time frame: at one-year
Change from baseline in self efficacy
Time frame: at 5 weeks
Change from baseline in self efficacy
Time frame: at 10 weeks
Change from baseline in self efficacy
Time frame: at one-year
Treatment credibility rating
Time frame: Baseline only
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 27 May 2020.
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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.
Monica Buhrman, PhD study director
Uppsala University
Gerhard Andersson, Professor study chair
Linkoeping University
Torsten Gordh, Professor 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 Internet-Delivered Cognitive Behavioral Therapy in people with Chronic Pain and Depressive Symptoms, run by Uppsala 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 6 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 27 May 2020. 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?
Change from baseline in depressive symptoms (time frame: at 10 weeks). The study lists 4 primary outcomes in all. 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 27 May 2020.