Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain

Study Overview
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Brief Summary
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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.

Official Title
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Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain - a Pilot Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy<br>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. | Behavioral: Acceptance and Commitment Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Interference Index (PII) | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life Inventory (PedsQL) | Change in quality of life for the adolescent. This questionnaire is composed of four subscales: Physical functioning (8 items), Emotional functioning (5 items), Social functioning (5 items), and School functioning (5 items). Each item has a scoring between 0 and 4, where a higher score indicate a better health-related quality of life. The subscales are summed together to a total score. | 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) | Change in depressive symptoms for the adolescent. Scores on the CES-DC are summed to a total score, ranging from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms. | 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) | 
| Insomnia Severity Index (ISI) | Change in insomnia severity for the adolescent. Scores on the seven items are summed into a total score, ranging from 0 to 28, where higher scores indicate greater severity of insomnia. | 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) | Change in psychological flexibility for the adolescent. PIPS is composed on two subscales: Avoidance (8 items) and Defusion (4 items). Each item has a scoring ranging between 0 and 6. Scores are summed into subscales and into a total scale. Higher scores indicate higher degree of psychological inflexibility. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Acceptance and Commitment Therapy, Smartphone