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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | 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. |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reactivity Scale - Parent (PRS-P) | Change in pain reactivity for the parent in relation to the child's pain. Each of the five items of the PRS-P is rated on a scale from 0 to 6, and summed together, with a maximum total score of 30. Higher scores indicate more pain reactivity. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rikard Wicksell, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 171 77 | Sweden |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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) |
| Parent Psychological Flexibility Questionnaire (PPFQ) | Change in psychological flexibility for the parent. A ten item questionnaire, with item scoring between 0 and 6. The PPFQ is summed into three subscales: Emotional acceptance (4 items), Values-based action (3 items), and Pain willingness (3 items). The subscales are also summed to a total score, where higher scores indicate more flexibility. | 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) |
| Patient Health Questionnaire (PHQ-9) | Change in depressive symptoms for the parent. PHQ-9 is a nine item inventory summed into a total scale, with scores ranging from 0 to 27. Higher scores indicate more 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) |
| Generalized Anxiety Disorder (GAD-7) | Change in anxiety symptoms for the parent. GAD-7 is a seven item inventory summed into a total scale, with scores ranging from 0 to 21. Higher scores indicate more anxiety. | 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) |