Chronic PainNCT07426367
Internet-Delivered ACT Targeting Emotional Distress and Chronic Pain
A study testing ACT in people with Chronic Pain, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for emotional distress and comorbid chronic pain. A pilot study ( N=5-10) will be conducted to test the intervention and assessment procedures. 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?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- emotional distress characterized by clinically significant symptoms of anxiety or depression age between 18-65 years were fully examined medically and had received medical treatment if indicated were able to be an active part of the rehabilitation process, regain functioning in different life areas and participate in treatment interventions for approximately 5 hours every week stable dose of medication able to read and write in Swedish had access to a smart phone or computer with internet access patient at department of pain rehabilitation, SUS
Who cannot join
- had acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ongoing substance dependence, untreated bipolar disorder, OCD, psychotic symptoms, severe depression, PTSD) were actively abusing analgesic medications (including narcotics), alcohol or other drugs had great difficulty to harbour and handle strong emotions that could lead to emotional outbursts or self-harming behavior had health risks due to medical reasons; had social or economic difficulties or lack of social support that hindered behavior change current severe suicidal ideation that warranted immediate intervention (indicated by the MINI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of pain rehabilitation
Lund
Sophia Åkerblom, 004646172610, sophia.akerblom@skane.se
About this study
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for emotional distress and comorbid chronic pain. A pilot study ( N=5-10) will be conducted to test the intervention and assessment procedures. The participants will go through an active internet-based ACT treatment focused on education about emotional distress and pain, as well as behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Read the detailed description
Objective The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT)for emotional distress and chronic pain.
Sample size 5-10 participants.
Trial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit at Skåne University Hospital. The unit is a government supported, regional specialist center focused on assessment and treatment of chronic pain and related disability.
Assessments Baseline and posttreatment (2 weeks after treatment) assessments will be conducted. Self-report measures will also be collected at baseline, post-treatment as well as during a 3-month follow up.
Assessment includes Pre-and post assessment. Assessors collected demographic information and self-report measures. During the pre-assessment a clinical interview was administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
During treatment During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment was following the introduction of the treatment rationale and the main treatment components (included in the internet program).
Safety parameters: Participants can report any adverse events during treatment, at posttreatment and follow-up assessment. Partcipants will be monitored daily (see below).
Post-treatment exit interview At the post-assessment, the assigned assessor asked participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.
Measures will be taken at baseline, 2-weeks, 3 months follow-up. Self-report measures will be mailed to participants
A single-case design with daily data collection during a baseline phase (A) and an intervention phase (B) will also be administered. The treatment intervention spans 8 weeks.
For the daily data collection, a shortened set of measures comprising approximately 10 items, focusing on psychological flexibility, pain intensity, and pain interference, will be used. Data will be collected via a digital platform, with secure handling of any personal data.
Main statistical analysis Between-group estimates on outcome will be conducted using repeated measurements. The analyses will be conducted using intention to treat principles and post hoc comparisons. Randomization test for the A/B single case data collection will be applied.
- Conditions
- Chronic Pain
- Being tested
- ACT
- Keywords
- emotional distress, ACT, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
Behavioral: Acceptance and commitment therapy The participants will go through an active internet-based ACT treatment focused on education about emotional distress and chronic pain, value-based exposure for avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Internet-based ACT Receives: Behavioral: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
as measured by the Multidimensional Pain Inventory (MPI). Changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.
Measured: Baseline, two-week-post treatment, 3 month-follow- up
Secondary outcomes (6)
Psychological inflexibility
as measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility
Measured: [Time Frame: Baseline, two-week-post treatment, 3 month-follow- up
Anxiety and depression
as measured by the Hospital Anxiety and Depression Scale (HADS) (changes between assessments) Min= 0; Max= 21. Higher scores indicate worse depression/anxiety.
Measured: Baseline, two-week-post treatment, 3 month-follow- up
Pain intensity
as measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity.
Measured: Baseline, two-week-post treatment, 3 month-follow- up
Pain catastrophizing
as measured by the Pain Catastrophizing Questionnaire (PCS) (changes between assessments) Min= 0; Max= 52. Higher scores indicate worse pain catastrophizing
Measured: Baseline, two-week-post treatment, 3 month-follow- up
Perceived health
as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36) (changes between assessments) Min= 0; Max= 100. Lower scores indicate worse perceived health
Measured: Baseline, two-week-post treatment, 3 month-follow- up
Kinesiophobia
as measured by the Tampa Scale of Kinesiophobia (Tampa) (changes between assessments) Min= 17; Max= 68. Higher scores indicate worse kinesiophobia
Measured: Baseline, two-week-post treatment, 3 month-follow- up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophia Åkerblom, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426367
- Sponsor's protocol ID
- 2019-00023
- Other IDs
- 2019
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Delivered ACT Targeting Emotional Distress and Chronic Pain
- ClinicalTrials.gov ID
- NCT07426367
- Acronym / sponsor ID
- 2019-00023
- Conditions
- Chronic Pain
- Keywords
- emotional distress, ACT, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (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 primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for emotional distress and comorbid chronic pain. A pilot study ( N=5-10) will be conducted to test the intervention and assessment procedures. The participants will go through an active internet-based ACT treatment focused on education about emotional distress and pain, as well as behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Detailed description
Objective The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT)for emotional distress and chronic pain.
Sample size 5-10 participants.
Trial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit at Skåne University Hospital. The unit is a government supported, regional specialist center focused on assessment and treatment of chronic pain and related disability.
Assessments Baseline and posttreatment (2 weeks after treatment) assessments will be conducted. Self-report measures will also be collected at baseline, post-treatment as well as during a 3-month follow up.
Assessment includes Pre-and post assessment. Assessors collected demographic information and self-report measures. During the pre-assessment a clinical interview was administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
During treatment During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment was following the introduction of the treatment rationale and the main treatment components (included in the internet program).
Safety parameters: Participants can report any adverse events during treatment, at posttreatment and follow-up assessment. Partcipants will be monitored daily (see below).
Post-treatment exit interview At the post-assessment, the assigned assessor asked participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.
Measures will be taken at baseline, 2-weeks, 3 months follow-up. Self-report measures will be mailed to participants
A single-case design with daily data collection during a baseline phase (A) and an intervention phase (B) will also be administered. The treatment intervention spans 8 weeks.
For the daily data collection, a shortened set of measures comprising approximately 10 items, focusing on psychological flexibility, pain intensity, and pain interference, will be used. Data will be collected via a digital platform, with secure handling of any personal data.
Main statistical analysis Between-group estimates on outcome will be conducted using repeated measurements. The analyses will be conducted using intention to treat principles and post hoc comparisons. Randomization test for the A/B single case data collection will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: ACTInternet-based ACT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- emotional distress characterized by clinically significant symptoms of anxiety or depression age between 18-65 years were fully examined medically and had received medical treatment if indicated were able to be an active part of the rehabilitation process, regain functioning in different life areas and participate in treatment interventions for approximately 5 hours every week stable dose of medication able to read and write in Swedish had access to a smart phone or computer with internet access patient at department of pain rehabilitation, SUS
Key exclusion criteria (1 listed)
- had acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ongoing substance dependence, untreated bipolar disorder, OCD, psychotic symptoms, severe depression, PTSD) were actively abusing analgesic medications (including narcotics), alcohol or other drugs had great difficulty to harbour and handle strong emotions that could lead to emotional outbursts or self-harming behavior had health risks due to medical reasons; had social or economic difficulties or lack of social support that hindered behavior change current severe suicidal ideation that warranted immediate intervention (indicated by the MINI)
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 |
|---|---|---|
| ACTBehavioral: Acceptance and commitment therapy The participants will go through an active internet-based ACT treatment focused on education about emotional distress and chronic pain, value-based exposure for avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours. | Behavioural | Treatment group |
Primary outcome
Pain interference
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
as measured by the Multidimensional Pain Inventory (MPI). Changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.
6 secondary outcomes
Psychological inflexibility
Time frame: [Time Frame: Baseline, two-week-post treatment, 3 month-follow- up
Anxiety and depression
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Pain intensity
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Pain catastrophizing
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Perceived health
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Kinesiophobia
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Chronic Pain, run by Skane University Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Åkerblom, Associate professor (004646172610, sophia.akerblom@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference (time frame: Baseline, two-week-post treatment, 3 month-follow- up). 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 10 Sep 2026.