Chronic PainACTsmartNCT03344926
Smart Phone ACT Treatment for Adults With Longstanding Pain - a Pilot Study
A study testing ACTsmart in people with Chronic Pain, run by Rikard Wicksell at 1 site in Sweden.
Trial summary
The aims are to test feasibility and preliminary effects of a smart phone delivered ACT treatment for adults with longstanding pain. The hypotheses are that 1. ACTsmart will be a feasible and accessable treatment delivery form 2. ACTsmart will improve function and quality of life 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?
- ACTsmart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 23 Oct 2017to 23 Dec 2019
- 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;
- able to read and write in Swedish
- have access to a smart phone with internet access
- 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)
- 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: ACTsmart - Feasibility of Smart Phone Delivered ACT Treatment for Adults With Longstanding Pain
The aims are to test feasibility and preliminary effects of a smart phone delivered ACT treatment for adults with longstanding pain.
The hypotheses are that
- ACTsmart will be a feasible and accessable treatment delivery form
- ACTsmart will improve function and quality of life
Read the detailed description
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced daily function and 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.
To make treatment more accessible and present in patients' daily life we will use a smart phone application to deliver treatment.
Recruitment Patients will be recruited through self referral. 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.
Interviews Evaluations of feasibility and as a base for further development of the smart phone application will be done via semi structured interviews during and after treatment period.
- Conditions
- Chronic Pain
- Being tested
- ACTsmart
- Keywords
- Acceptance and Commitment therapy, ACT, CBT, Smart phone, Internet, Intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTsmartBehavioural
Participant receive ACT treatment via a smart phone application, including psychologist support via a message function within the application.
Treatment content is divided into four modules:
- education about pain behaviors, exposure and acceptance and commitment therapy
- education about pain physiology
- exercises on changing behaviors, acceptance, mindfulness, defusion and exposure
- value based exposure in the participant's daily life
| Study group | Role | What they receive |
|---|---|---|
| ACTsmart | Experimental | ACT treatment via a smart phone application Receives: Behavioral: ACTsmart |
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, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Secondary outcomes (9)
Psychological Inflexibility in Pain Scale (changes)
Self rated psychological inflexibility related to pain. Total score min 12, max 84, lower values are interpreted as higher psychological flexibility, higher values interpreted as lower psychological flexibility. Two subscales; fusion (4-28) and avoidance (8-56) are summed to compute a total score.
Measured: Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Valuing Questionnaire (changes)
Self rated progress and obstacles in valued actions. The Valuing Questionnaire consists of two subscales: progress (0-30) och obstacles (0-30). No total score is computed. On the obstacle subscale higher scores are worse, and on the progress subscale higher scores are better.
Measured: Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Patient Health Questionnaire 9 (changes)
Self rated depressive symptoms. Score is summed to a possible range of 0 to 27. Higher scores are interpreted as worse.
Measured: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
European Quality of Life Five Dimensions Questionnaire (changes)
Self rated quality of life. Scores are calculated to a number between 0 and 1, where 0 in theory is equal to death, and 1 is considered equal to perfect quality of life.
Measured: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Insomnia Severity Index (changes)
Self rated degree of insomnia
Measured: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Pain intensity (changes)
Self rated degree of pain during last week on a scale from 0-10
Measured: Baseline, post (8 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 sick retirement
Measured: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Generalized Anxiety Disorder - 7 (changes)
Self rated symptoms of anxiety
Measured: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Medication use (changes)
Self reported medicine use
Measured: Baseline, post (8 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 posted17 Nov 2017
- Study start23 Oct 2017
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study of treatment delivery in a new format.
- Masking
- None (open label)
- Enrolment
- 34 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, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344926
- Sponsor's protocol ID
- 2015/1638-31/2:2
- Acronym
- ACTsmart
- Status last verified
- Jan 2020
- First submitted
- 14 Nov 2017
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTsmart - Feasibility of Smart Phone Delivered ACT Treatment for Adults With Longstanding Pain
- ClinicalTrials.gov ID
- NCT03344926
- Acronym / sponsor ID
- ACTsmart / 2015/1638-31/2:2
- Conditions
- Chronic Pain
- Keywords
- Acceptance and Commitment therapy, ACT, CBT, Smart phone, Internet, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rikard WicksellUniversity, hospital or other
- Collaborators
- AFA Insurance
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 17 Nov 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 aims are to test feasibility and preliminary effects of a smart phone delivered ACT treatment for adults with longstanding pain.
The hypotheses are that
- ACTsmart will be a feasible and accessable treatment delivery form
- ACTsmart will improve function and quality of life
Detailed description
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced daily function and 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.
To make treatment more accessible and present in patients' daily life we will use a smart phone application to deliver treatment.
Recruitment Patients will be recruited through self referral. 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.
Interviews Evaluations of feasibility and as a base for further development of the smart phone application will be done via semi structured interviews during and after treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of treatment delivery in a new format.
| Arm | Type | Receives |
|---|---|---|
| ACTsmart | Experimental | Behavioral: ACTsmartACT treatment via a smart phone application |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a pain duration of ≥ 6 months;
- able to read and write in Swedish
- have access to a smart phone with internet access
- 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)
- 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 |
|---|---|---|
| ACTsmartParticipant receive ACT treatment via a smart phone application, including psychologist support via a message function within the application. Treatment content is divided into four modules: 1. education about pain behaviors, exposure and acceptance and commitment therapy 2. education about pain physiology 3. exercises on changing behaviors, acceptance, mindfulness, defusion and exposure 4. value based exposure in the participant's daily life | Behavioural | ACTsmart |
Primary outcome
Pain Interference Index (changes between assessments)
Time frame: Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Self rated measure of daily functioning related to pain
9 secondary outcomes
Psychological Inflexibility in Pain Scale (changes)
Time frame: Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Valuing Questionnaire (changes)
Time frame: Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Patient Health Questionnaire 9 (changes)
Time frame: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
European Quality of Life Five Dimensions Questionnaire (changes)
Time frame: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Insomnia Severity Index (changes)
Time frame: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Pain intensity (changes)
Time frame: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Occupational status (changes)
Time frame: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Generalized Anxiety Disorder - 7 (changes)
Time frame: Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Medication use (changes)
Time frame: Baseline, post (8 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 22 Jan 2020.
- 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 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 ACTsmart 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 4 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 22 Jan 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?
Pain Interference Index (changes between assessments) (time frame: Baseline, 8 weekly ratings, post (8 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 NCT03344926, 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 22 Jan 2020.