Chronic Pain Clinical Trial
Official title:
Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain - a Pilot Study
Verified date | January 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 19, 2019 |
Est. primary completion date | September 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Karolinska University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | |
Other | 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) | |
Other | 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) | |
Other | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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). | |
Secondary | 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) |
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