ACTonPainSCI - A randomised controlled pilot study to test the effectiveness of the online-based pain programme ACTonPain in people with paraplegia and chronic pai

Not Applicable

• Conditions: Chronic pain that has been present for at least 3 months and leads to severe impairments in everyday life.; G82; Paraplegia and tetraplegia

• Registration Number: DRKS00031439
• Lead Sponsor: Klinik für psychosomatische Medizin und Psychotherapie, Universitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-21
• Study Completion: 2024-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Diagnosis of spinal cord injury
Presence of chronic pain (at least 3 months)
Significant pain impairment (at least grade II according to the
Chronic Pain Grade questionnaire (CPG; Korff et al. 1992)
Medical requirements for participation in an internet-based pain program are given
Sufficient knowledge of German
Sufficient computer and internet skills
Internet access available

Exclusion Criteria

Tumor-associated pain
Ongoing or promptly planned outpatient psychotherapy or (partial) inpatient psychotherapy or inpatient treatment in a paraplegic center within the next three months.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3 measurement time points (self-report via questionnaires): Baseline measurement at time point T0 (before randomization), interim measurement at time point T1 (5 weeks after randomization), and the follow-up survey at time point T2 (10 weeks after randomization).<br><br>Pain interference measured with the Pain Disability Index (PDI) as primary endpoint at T2 (after 10 weeks).

Secondary Outcome Measures

Name	Time	Method
Pain intensity: Numerical rating scale<br>Physical functioning: interference items of the BPI (Brief Pain Inventory)<br>Emotional functioning: Patient Health Questionnaire (PHQ-8) & Generalized Anxiety Disorder (GAD-7) <br>Life satisfaction: Satisfaction with Life Scale (SWLS) <br>Quality of Life: WHOQOL-BREF Health-Related <br><br>ACT-related outcome parameters<br>Psychological flexibility: Questionnaire on Acceptance and Action II (FAH-II) <br>Pain acceptance: German version of the Chronic Pain Acceptance Questionnaire (CPAQ-D) <br>Committed Action (Behavioral Activation): Committed Action Questionnaire CAQ-G <br>cognitive defusion: German version of the Cognitive Fusion Questionnaire CFQ-D <br>Mindfulness: German version of the Five Facet Mindfulness Questionnaire (FFMQ-D)