Internet-based ACT for Endometriosis and Chronic Pain

Chronic Pain Clinical Trial

Official title:

A Pilot Study of Internet-based ACT for Endometriosis and Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153303
• Other study ID #: SkaneU3
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2024
• Source: Skane University Hospital
• Contact: Sophia Åkerblom, PhD
• Phone: 004646171520
• Email: sophia.akerblom[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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))

Related Conditions & MeSH terms

• Chronic Pain
• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skåne unviersity Hospital	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health care utilization as measured by the health-care database of Region Skåne	(changes between assessments)	Baseline, 3 month-follow- up
Secondary	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