EndometriosisNCT06153303
Internet-based ACT for Endometriosis and Chronic Pain
A study testing Acceptance and commitment therapy in people with Endometriosis and 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 endometriosis and chronic pain. A pilot study (no randomization; N=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, women only
- Conditions the study is for
- Endometriosis, Chronic Pain
- What is being tested?
- 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
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to 31 Dec 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- verified endometriosis
- 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
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 and a score of 3 to item 9 of the Patient Health Questionnaire 9-item version (PHQ9))
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
Skåne unviersity Hospital
Lund, Skåne County, 22241
Sophia Åkerblom, PhD, sophia.akerblom@skane.se
About this study
Official title: A Pilot Study of Internet-based ACT for Endometriosis and Chronic Pain
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for endometriosis and chronic pain. A pilot study (no randomization; N=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 endometriosis 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.
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 endometriosis.
Sample size 10 participants.
Trial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit and the team for endometriosis 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 the Mini International Neuropsychiatric Interview 5.0 (MINI) 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 was 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: As a mean to monitor safety and progress participants complete self-report measures (MPI, NRS, PIPS, PCS) and a question about suicidal ideation twice during the program and the therapist can follow these scores. In addition, participants can report any adverse events during treatment, at posttreatment and follow-up assessment.
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 were taken at baseline, 2-weeks, 3 months follow-up. Self-report measures were mailed to participants
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.
- Conditions
- Endometriosis, Chronic Pain
- Being tested
- Acceptance and commitment therapy
- Keywords
- endometriosis, chronic pain
- Medical subject headings
- Endometriosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
The participants will go through an active internet-based ACT treatment focused on education about endometriosis 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 | Acceptance and commitment therapy Receives: Behavioral: Acceptance and commitment therapy |
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, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up
Secondary outcomes (8)
Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)
(changes between assessments) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility
Measured: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), 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, mid-treatment (3 weeks), mid-treatment (5 weeks), 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, mid-treatment (3 weeks), mid-treatment (5 weeks), 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
Health care utilization as measured by the health-care database of Region Skåne
(changes between assessments)
Measured: Baseline, 3 month-follow- up
Health-related quality of life as measured by the Endometriosis Health Profile (EHP-30)
(changes between assessments) Min=0; Max= 100. Lower scores indicate better health-related quality of life
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 posted1 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- NCT06153303
- Sponsor's protocol ID
- SkaneU3
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2023
- Last updated
- 19 Feb 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Internet-based ACT for Endometriosis and Chronic Pain
- ClinicalTrials.gov ID
- NCT06153303
- Acronym / sponsor ID
- SkaneU3
- Conditions
- Endometriosis, Chronic Pain
- Keywords
- endometriosis, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Dec 2023 (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 endometriosis and chronic pain. A pilot study (no randomization; N=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 endometriosis 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.
Detailed description
Objective The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT)for endometriosis.
Sample size 10 participants.
Trial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit and the team for endometriosis 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 the Mini International Neuropsychiatric Interview 5.0 (MINI) 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 was 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: As a mean to monitor safety and progress participants complete self-report measures (MPI, NRS, PIPS, PCS) and a question about suicidal ideation twice during the program and the therapist can follow these scores. In addition, participants can report any adverse events during treatment, at posttreatment and follow-up assessment.
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 were taken at baseline, 2-weeks, 3 months follow-up. Self-report measures were mailed to participants
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.
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: Acceptance and commitment therapyAcceptance and commitment therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- verified endometriosis
- 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
Key exclusion criteria (6 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
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 |
|---|---|---|
| Acceptance and commitment therapyThe participants will go through an active internet-based ACT treatment focused on education about endometriosis 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 as measured by the Multidimensional Pain Inventory (MPI)
Time frame: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up
(changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.
8 secondary outcomes
Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)
Time frame: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up
Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Pain intensity as measured by the Numerical Rating Scale (NRPS)
Time frame: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up
Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)
Time frame: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), 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)
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
Health care utilization as measured by the health-care database of Region Skåne
Time frame: Baseline, 3 month-follow- up
Health-related quality of life as measured by the Endometriosis Health Profile (EHP-30)
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 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
RecruitingPhase 4
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Ovarian Endometrioma, Endometrioma
Recruiting
Evaluating the Feasibility of elleFA App Implementation
Endometriosis
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 Acceptance and commitment therapy in people with Endometriosis and 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 7 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: looking for participants now, as of the sponsor's last update on 19 Feb 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, PhD (004646171520, 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 as measured by the Multidimensional Pain Inventory (MPI) (time frame: Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), 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 19 Feb 2026.