Department of pain rehabilitation
Lund, Sweden
Location status: Recruiting
NCT Number: NCT07813728
The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for youth with PTSD and comorbid chronic pain. A pilot study (no randomization; N=5-10) 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 PTSD, value-based exposure for the traumatic memory and 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 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Interested in participating?
Request Info15 year–24 year
All sexes
Interventional
Not applicable
Lund, Sweden
Location status: Recruiting
Objective: The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT) for youth with PTSD and comorbid chronic pain.
Sample size: 5-10 participants.
Trial design: All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit 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 post treatment (2 weeks after treatment) assessments will be conducted by an assessor who is trained to administer the study measures. Self-report measures will also be collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up.
Pre-and post assessment: Assessors will collect demographic information, self-report measures, and trauma history. During the pre- and post-assessment the Clinician-Administered PTSD Scale for DSM-5 will be administered to establish PTSD whether participants met the DSM-5 criteria for PTSD.
During the pre-assessment a clinical interview will be administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
Post-treatment exit interview: At the post-assessment, the assigned assessor will ask participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.
During treatment: During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment is 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 a short daily diary during the baseline and treatment phases. In addition, participants can report any adverse events during treatment, at post treatment and follow-up assessment.
Data collection: Self-report measures will be mailed to participants
A single-case design with daily data collection during a baseline phase (A) and an intervention phase (B) will also be used. The treatment intervention spans 10 weeks.
For the daily data collection, a shortened set of measures comprising approximately 10 items focusing on ptsd symptoms, psychological flexibility, and pain intensity will be used. Data will be collected via a digital platform, with secure handling of any personal data.
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. Randomization test for the A/B single case data collection will be conducted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and 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 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Time frame: Baseline, two-week-post treatment, 3 month-follow-up.
The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
Time frame: Baseline, two-week-post treatment, 3 month-follow- up
As measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility
Time frame: Baseline, two-week-post treatment, 3 month-follow up
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- up
As measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity.
Time frame: Baseline, two-week-post treatment, 3 month-follow-up
As measured by the Swedish Acceptance and Action Questionnaire (SAAQ) (changes between assessments)
Time frame: Baseline, two-week-post treatment, 3 month-follow-up
As measured by Parental Acceptance and Action Questionnaire (PAAQ)
Contact information is provided by the study sponsor or research team.
Skane University Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07225049
Chronic Pain, Mental Disorders
New York, United States
View Trial DetailsNCT05147948
Chronic Pain, Mental Disorders
Lund, Sweden
View Trial DetailsNCT05700279
Acute Pain, Chronic Pain
Chicago, Illinois, United States
View Trial DetailsNCT04512755
Chronic Disease, Chronic Pain
Seattle, Washington, United States
View Trial Details