Internet-based ACT for Endometriosis and Chronic Pain

NCT06153303 | Recruiting

• 1 other identifier: SkaneU3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis; Chronic Pain

Keywords

endometriosis; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)

  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)

  Baseline, two-week-post treatment, 3 month-follow- up

• Pain intensity as measured by the Numerical Rating Scale (NRPS)

  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)

  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)

  Baseline, two-week-post treatment, 3 month-follow- up

Study Arms (1)

treatment group

EXPERIMENTAL

Acceptance and commitment therapy

Behavioral: Acceptance and commitment therapy

Interventions

Acceptance and commitment therapy BEHAVIORAL

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Skåne unviersity Hospital

Lund, Skåne County, 22241, Sweden

RECRUITING

MeSH Terms

Conditions

Endometriosis; Chronic Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sophia Åkerblom, PhD

CONTACT

004646171520; sophia.akerblom@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: December 1, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)