Internet-based ACT for Endometriosis and Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSkane University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Acceptance and commitment therapy
BehavioralThe 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 groups
10 Participants
are divided into 1 treatment groupGroup A: treatment groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- upSecondary outcomes
1
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
Time frame
Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up2
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.
Time frame
Baseline, two-week-post treatment, 3 month-follow- up3
Pain intensity as measured by the Numerical Rating Scale (NRPS)
(changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity.
Time frame
Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up4
Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)
(changes between assessments) Min= 0; Max= 52. Higher scores indicate worse pain catastrophizing.
Time frame
Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- upSponsors and contacts
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Source ClinicalTrials.gov