Clinical trial NCT03472248: Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain
Official title: Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Adolescents
Acceptance and Commitment Therapy
Smartphone
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2018-03-21
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intervention study with uncontrolled design investigating the effects of smartphone delivered Acceptance and Commitment Therapy for longstanding pain in adolescents. Primary outcome is pain interference. Internet-based parental support will be offered to the adolescents' caregivers.


Eligibility criteria: Inclusion Criteria:

* pain duration of ≥ 3 months;
* the pain condition has been examined by a medical doctor
* able to communicate in Swedish
* access to a smartphone and internet connection on a daily basis
* stable medication use since 2 months time, with no planned changes

Exclusion Criteria:

* previous ACT or CBT treatment during the past 6 months
* severe psychiatric co-morbidity (e.g. psychosis or high risk of suicide) as assessed by the psychologist in a semi-structured interview

Primary outcomes:
measure: Pain Interference Index (PII)
timeFrame: Pre-treatment, weekly for eight weeks (during treatment), after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
measure: Insomnia Severity Index (ISI)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up).
measure: Psychological Inflexibility in Pain Scale (PIPS)
timeFrame: Pre-treatment, weekly for eight weeks (during treatment), after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
Other outcomes:
measure: Pain Reactivity Scale - Parent (PRS-P)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
measure: Parent Psychological Flexibility Questionnaire (PPFQ)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Rikard Wicksell, MD
role: PRINCIPAL_INVESTIGATOR
References: