Chronic PainiACTNCT03105908
Internet-delivered ACT for Chronic Pain
A study testing Internet delivered Acceptance and Commitment therapy in people with Chronic Pain, run by Rikard Wicksell at 1 site in Sweden.
Trial summary
The overall aim of the present study is to evaluate an internet-delivered Acceptance and Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the study will evaluate if 1) iACT is effective in improving functioning and quality of life in comparison to a waitlist condition, 2) if iACT… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Internet delivered Acceptance and Commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSweden
- Study dates
- 16 Mar 2017to 31 Oct 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a pain duration of ≥ 6 months;
- are able to communicate in Swedish
- have access to computer and internet in their home environment.
- have access to a cell phone with the possibility of receiving text messages
- no planned changes in medication use, or any other changes in interventions for their pain planned
Who cannot join
- injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months
- unstable medication (planned changes in medication during next 4 months)
- previous ACT or CBT treatment during the past 3 months
- severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered ACT Treatment for Patients With Chronic Pain: A Randomized Controlled Trial
The overall aim of the present study is to evaluate an internet-delivered Acceptance and Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the study will evaluate if 1) iACT is effective in improving functioning and quality of life in comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence treatment outcome (i.e. predictors, moderators or characteristics of treatment responders), 4) if psychological variables mediates the effects of treatment on outcome, and 5) if subgroups of patients varies in change processes (i.e. moderated mediation).
The main hypothesis is that iACT will improve functioning and quality of life.
Read the detailed description
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced quality of life. Medical strategies are often ineffective or insufficient to alleviate symptoms and increase functioning. Instead, the empirical support for cognitive behavior therapy (CBT) is today well established, and such interventions are commonly seen as critically important for patients with chronic pain. However, modest effects sizes calls for further improvements. Recent developments within CBT, particularly Acceptance and Commitment Therapy (ACT), have suggested the utility of acceptance and mindfulness strategies to manage pain and distress. The body of evidence for ACT has grown rapidly during the past decade, and ACT is today listed by the American Psychological Association as a treatment for chronic pain, with strong empirical support.
Internet-delivered ACT
Despite the increased empirical support for ACT the availability is still very limited, and a large number of patients do not receive this treatment. In other domains, the accessibility of empirically supported treatments has increased during the past decade due to the development of methods to deliver the treatment via internet. For example, a large number of studies illustrate the utility of internet-delivered CBT for anxiety, insomnia and depression, with treatment effects similar to those obtained in studies with face-to-face treatment. Few studies have yet evaluated internet-delivered ACT (iACT) for chronic pain, but a recent pilot study from our group with participants suffering from fibromyalgia (n=41) illustrated very promising results that warrant further studies to evaluate the effects of this treatment.
Moderators and mediators of treatment outcome
If iACT shows to be effective, it is vital to identify for whom this treatment works. For example, it is possible that factors such as age, pain duration or depression may moderate the effects of treatment. Also, it is likely that some individuals who respond well to regular face-to-face treatment do not benefit from internet-delivered interventions. Furthermore, recent studies have shown that acceptance of pain and distress may be a more important mediator of change than e.g. pain intensity, catastrophizing or anxiety. However, no study has to our knowledge yet explored if subgroups of patients (e.g. men and women) improve via different change processes (i.e. moderated mediation). More information regarding moderators and mediators of change will make it possible to adjust and tailor interventions to meet specific individual needs, and thereby increase the effects of treatment.
Recruitment
Patients will be recruited through self referral. Thus, information regarding the study will be provided through newspapers and social media, as well as in direct communication with pain clinics and primary care units, including instructions regarding e.g. eligibility and how to sign up. Once patients have been found eligible and expressed interest in study participation they will be assessed by a psychologist, and when needed by a pain physician, via semi-structured interviews to confirm eligibility and to ensure that the patient meet the study criteria. Informed consent is obtained from all participants prior to the assessment.
Statistical methods
Evaluations of treatment effects are primarily based on intent-to-treat analyses. The statistical approach will primarily be based on linear multilevel modeling (LMM), which takes into account dependencies between repeated measures and differences between patients in pre-treatment status and treatment response (i.e. random effects modeling) and also provide means of handling missing data. More traditional methods, such as ANOVA and hierarchical regression, may also be utilized when appropriate. Analyses of change processes (mediation, moderation, moderated mediation) will follow guidelines and recommendations (e.g. cross-product of coefficients approach, bootstrapping). The main health economic outcomes will be the incremental cost-effectiveness ratio, which is a measure of the relationship between the cost of the treatment and the incremental value it provides in terms of functioning, compared to the control condition.
- Conditions
- Chronic Pain
- Being tested
- Internet delivered Acceptance and Commitment therapy, Waiting list control condition
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet delivered Acceptance and Commitment therapyBehavioural
Also called iACT
The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.
Waiting list control conditionBehavioural
After a ten week wait list period, the control condition receive same treatment as the intervention group, but without therapist support.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Internet delivered Acceptance and Commitment therapy, supported by a psychologist/psychology student under supervision. Receives: Behavioral: Internet delivered Acceptance and Commitment therapy |
| Waiting list control condition | Other | Participants receive no treatment for ten weeks, i.e. waiting list condition. Following post-assessment, the control condition receive unguided iACT (i.e. the same content and structure as iACT but without systematic therapist communication). Receives: Behavioral: Waiting list control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference Index (changes between assessments)
Self rated measure of daily functioning related to pain
Measured: Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment
Secondary outcomes (10)
The Valuing Questionnaire (changes)
Self rated progress and obstacles in valued actions
Measured: Baseline, mid (4 weeks), post (10 weeks), follow ups three, six and twelve months post treatment
Psychological Inflexibility in Pain Scale (changes)
Self rated psychological inflexibility related to pain
Measured: Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment
Patient Health Questionnaire 9 (changes)
Self rated depressive symptoms
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
European Quality of Life Five Dimensions Questionnaire (changes)
Self rated quality of life
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Insomnia Severity Index (changes)
Self rated degree of insomnia
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Pain Intensity (changes)
Self rated degree of pain during the last week on a scale from 0-10
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Occupational status (changes)
Self reported occupational status indicated on a pre specified list, including sick leave and/or retirement
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Perceived Stress Scale - 4 items (changes)
Self rated level of perceived stress
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
General Anxiety Disorder - 7 item (changes)
Self rated symptoms of general anxiety
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Medication use (changes)
Self reported medicine use
Measured: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start16 Mar 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rikard Wicksell
- Sponsor type
- University, hospital or other
- Collaborators
- AFA Insurance
- Responsible party
- Sponsor-investigator, Rikard Wicksell, Karolinska Institutet
- Investigators
- Rikard Wicksell, PhD, MSc, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105908
- Sponsor's protocol ID
- 2015/1638-31/2
- Acronym
- iACT
- Status last verified
- Jan 2019
- First submitted
- 15 Mar 2017
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gentili C, Zetterqvist V, Rickardsson J, Holmstrom L, Ljotsson B, Wicksell R. Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain. Cogn Behav Ther. 2023 Jul;52(4):380-396. doi: 10.1080/16506073.2023.2191826. Epub 2023 Mar 27.
PubMed 36971108
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered ACT Treatment for Patients With Chronic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03105908
- Acronym / sponsor ID
- iACT / 2015/1638-31/2
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Rikard WicksellUniversity, hospital or other
- Collaborators
- AFA Insurance
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 10 Apr 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.
The overall aim of the present study is to evaluate an internet-delivered Acceptance and Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the study will evaluate if 1) iACT is effective in improving functioning and quality of life in comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence treatment outcome (i.e. predictors, moderators or characteristics of treatment responders), 4) if psychological variables mediates the effects of treatment on outcome, and 5) if subgroups of patients varies in change processes (i.e. moderated mediation).
The main hypothesis is that iACT will improve functioning and quality of life.
Detailed description
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced quality of life. Medical strategies are often ineffective or insufficient to alleviate symptoms and increase functioning. Instead, the empirical support for cognitive behavior therapy (CBT) is today well established, and such interventions are commonly seen as critically important for patients with chronic pain. However, modest effects sizes calls for further improvements. Recent developments within CBT, particularly Acceptance and Commitment Therapy (ACT), have suggested the utility of acceptance and mindfulness strategies to manage pain and distress. The body of evidence for ACT has grown rapidly during the past decade, and ACT is today listed by the American Psychological Association as a treatment for chronic pain, with strong empirical support.
Internet-delivered ACT
Despite the increased empirical support for ACT the availability is still very limited, and a large number of patients do not receive this treatment. In other domains, the accessibility of empirically supported treatments has increased during the past decade due to the development of methods to deliver the treatment via internet. For example, a large number of studies illustrate the utility of internet-delivered CBT for anxiety, insomnia and depression, with treatment effects similar to those obtained in studies with face-to-face treatment. Few studies have yet evaluated internet-delivered ACT (iACT) for chronic pain, but a recent pilot study from our group with participants suffering from fibromyalgia (n=41) illustrated very promising results that warrant further studies to evaluate the effects of this treatment.
Moderators and mediators of treatment outcome
If iACT shows to be effective, it is vital to identify for whom this treatment works. For example, it is possible that factors such as age, pain duration or depression may moderate the effects of treatment. Also, it is likely that some individuals who respond well to regular face-to-face treatment do not benefit from internet-delivered interventions. Furthermore, recent studies have shown that acceptance of pain and distress may be a more important mediator of change than e.g. pain intensity, catastrophizing or anxiety. However, no study has to our knowledge yet explored if subgroups of patients (e.g. men and women) improve via different change processes (i.e. moderated mediation). More information regarding moderators and mediators of change will make it possible to adjust and tailor interventions to meet specific individual needs, and thereby increase the effects of treatment.
Recruitment
Patients will be recruited through self referral. Thus, information regarding the study will be provided through newspapers and social media, as well as in direct communication with pain clinics and primary care units, including instructions regarding e.g. eligibility and how to sign up. Once patients have been found eligible and expressed interest in study participation they will be assessed by a psychologist, and when needed by a pain physician, via semi-structured interviews to confirm eligibility and to ensure that the patient meet the study criteria. Informed consent is obtained from all participants prior to the assessment.
Statistical methods
Evaluations of treatment effects are primarily based on intent-to-treat analyses. The statistical approach will primarily be based on linear multilevel modeling (LMM), which takes into account dependencies between repeated measures and differences between patients in pre-treatment status and treatment response (i.e. random effects modeling) and also provide means of handling missing data. More traditional methods, such as ANOVA and hierarchical regression, may also be utilized when appropriate. Analyses of change processes (mediation, moderation, moderated mediation) will follow guidelines and recommendations (e.g. cross-product of coefficients approach, bootstrapping). The main health economic outcomes will be the incremental cost-effectiveness ratio, which is a measure of the relationship between the cost of the treatment and the incremental value it provides in terms of functioning, compared to the control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Behavioral: Internet delivered Acceptance and Commitment therapyInternet delivered Acceptance and Commitment therapy, supported by a psychologist/psychology student under supervision. |
| Waiting list control condition | Other | Behavioral: Waiting list control conditionParticipants receive no treatment for ten weeks, i.e. waiting list condition. Following post-assessment, the control condition receive unguided iACT (i.e. the same content and structure as iACT but without systematic therapist communication). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a pain duration of ≥ 6 months;
- are able to communicate in Swedish
- have access to computer and internet in their home environment.
- have access to a cell phone with the possibility of receiving text messages
- no planned changes in medication use, or any other changes in interventions for their pain planned
Key exclusion criteria (4 listed)
- injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months
- unstable medication (planned changes in medication during next 4 months)
- previous ACT or CBT treatment during the past 3 months
- severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview
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 Acceptance and Commitment therapyAlso: iACTThe main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort. | Behavioural | Treatment |
| Waiting list control conditionAfter a ten week wait list period, the control condition receive same treatment as the intervention group, but without therapist support. | Behavioural | Waiting list control condition |
Primary outcome
Pain Interference Index (changes between assessments)
Time frame: Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment
Self rated measure of daily functioning related to pain
10 secondary outcomes
The Valuing Questionnaire (changes)
Time frame: Baseline, mid (4 weeks), post (10 weeks), follow ups three, six and twelve months post treatment
Psychological Inflexibility in Pain Scale (changes)
Time frame: Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment
Patient Health Questionnaire 9 (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
European Quality of Life Five Dimensions Questionnaire (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Insomnia Severity Index (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Pain Intensity (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Occupational status (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Perceived Stress Scale - 4 items (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
General Anxiety Disorder - 7 item (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months post treatment
Medication use (changes)
Time frame: Baseline, post (10 weeks), follow ups three, six and twelve months 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 3 Jan 2019.
- Derived from this study: PubMed 36971108Gentili C, Zetterqvist V, Rickardsson J, Holmstrom L, Ljotsson B, Wicksell R. Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain. Cogn Behav Ther. 2023 Jul;52(4):380-396. doi: 10.1080/16506073.2023.2191826. Epub 2023 Mar 27.
- 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.
Rikard Wicksell, PhD, MSc principal investigator
Karolinska Institutet
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 Acceptance and Commitment therapy in people with Chronic Pain, run by Rikard Wicksell 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 3 Jan 2019. 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?
Pain Interference Index (changes between assessments) (time frame: Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105908, which also lists 1 linked publication.
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 3 Jan 2019.