Chronic Pain Clinical Trial
Official title:
Internet-based Acceptance and Commitment Therapy for PTSD and Chronic Pain
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for PTSD and comorbid chronic pain using a randomized controlled trial with waitlist control.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 18, 2026 |
Est. primary completion date | October 18, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - a CAPS of =25 - subjected to single traumatic events - were able to understand Swedish - had symptoms of chronic pain that interfered significantly with everyday life - 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: - repeated and extensive traumatic events - had other 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) - 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)) |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Pain Pehabilitation, Skåne University Hospital | Lund |
Lead Sponsor | Collaborator |
---|---|
Skane University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) and the Life Events Checklist (LEC-5) | (changes between assessments) | Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | General acceptance as measured by the Swedish Acceptance and Action Questionnaire (SAAQ) | (changes between assessments) | Baseline, mid-treatment (3 weeks), mid-treatment (7 weeks), two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Posttraumatic Cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Pain interference as measured by the Multidimensional Pain Inventory (MPI) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Pain intensity as measured by the Numerical Rating Scale (NRPS) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Perceived health as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa) | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Pain-acceptance as measured by the Chronic Pain Acceptance Questionnaire-8 | (changes between assessments) | Baseline, two-week-post treatment, 3 month-follow-up, 12-month follow-up. | |
Secondary | Health care utilization from health-care database of Region Skåne | (changes between assessments) | Baseline, two-week-post treatment, 12-month follow-up. | |
Secondary | Health care utilization, pharmaeconomics, medication use, and return to work as measured by the MiDAS-database of the Swedish Social Insurance Agency, the Swedish Prescribed Drug Register and health-care database of Region Skåne | (changes between assessments) | Baseline, two-week-post treatment, 12-month follow-up. | |
Secondary | Medication use from the Swedish Prescribed Drug Register | (changes between assessments) | Baseline, two-week-post treatment,12-month follow-up. | |
Secondary | Number of adverse events reported by the participant | 2-week-post treatment. |
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