Internet-Delivered Acceptance and Commitment Therapy (iACT) for Youth With PTSD and Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a CAPS of ≥25 and a diagnosis of PTSD
subjected to single traumatic events
aged 15-24 years
had symptoms of chronic pain that interfered significantly with everyday life
Disqualifiers
repeated and extensive traumatic events
had other acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ADHD, autism spectrum disorder, 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 self-harming behavior
Trial design
Design model
Single group
Treatments tested in this trial
iACT
BehavioralThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: iACTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
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.2
Psychological inflexibility
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- upSecondary outcomes
1
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 up2
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, two-week-post treatment, 3 month-follow- up3
General acceptance
As measured by the Swedish Acceptance and Action Questionnaire (SAAQ) (changes between assessments)
Time frame
Baseline, two-week-post treatment, 3 month-follow-upOther outcomes
1
Parental psychological flexibility
As measured by Parental Acceptance and Action Questionnaire (PAAQ)
Time frame
Baseline, two-week-post treatment, 3 month-follow-upSponsors and contacts
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Source ClinicalTrials.gov