Internet-based ACT for Endometriosis and Chronic Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Endometriosis
• Intervention / Treatment: Behavioral: Acceptance and commitment therapy

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Åkerblom, PhD; Phone Number: 004646171520; Email: sophia.akerblom@skane.se

Study Locations

• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 22241
      • Recruiting
      • Skåne unviersity Hospital
      • Contact: Sophia Åkerblom, PhD; Email: sophia.akerblom@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treatment group; Acceptance and commitment therapy

Behavioral: Acceptance and commitment therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain interference as measured by the Multidimensional Pain Inventory (MPI)	(changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.	Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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	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)	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	Baseline, two-week-post treatment, 3 month-follow- up

Collaborators and Investigators

• Sponsor: Skane University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; endometriosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Endometriosis; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: SkaneU3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No