Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT03472248
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-21
• Study Start: 2018-03-23
• Primary Completion: 2019-09-19
• Study Completion: 2019-09-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-18
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	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.

Primary Outcome Measures

Name	Time	Method
Pain Interference Index (PII)	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 Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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)	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.
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).	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.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden