Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pain Interference Index (PII)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Acceptance and Commitment Therapy
Eight weeks of smartphone delivered Acceptance and Commitment Therapy for the adolescent and eight weeks of internet delivered parental support to one or two parents of the adolescent.
Intervention: Acceptance and Commitment Therapy (Behavioral)
Outcomes
Primary Outcomes
Pain Interference Index (PII)
Time Frame: 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)
Change in pain interference on the adolescent daily activities. Items are rated on a 7-point Likert scale, and the total score is the mean of the completed items. Higher scores indicate more interference.
Secondary Outcomes
- Pediatric Quality of Life Inventory (PedsQL)(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))
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(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))
- Psychological Inflexibility in Pain Scale (PIPS)(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))
- Insomnia Severity Index (ISI)(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).)
Investigators
Rikard Wicksell
Associate Professor
Karolinska Institutet