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Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain

Primary Purpose

Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Acceptance and Commitment Therapy

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Adolescents, Acceptance and Commitment Therapy, Smartphone

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acceptance and Commitment Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT03472248

First Posted

March 14, 2018

Last Updated

January 18, 2020

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03472248

Brief Title

Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

March 23, 2018 (Actual)

Primary Completion Date

September 19, 2019 (Actual)

Study Completion Date

September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Adolescents, Acceptance and Commitment Therapy, Smartphone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acceptance and Commitment Therapy

Arm Type

Experimental

Arm Description

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 Type

Behavioral

Intervention Name(s)

Acceptance and Commitment Therapy

Intervention Description

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 Measure Information:

Title

Pain Interference Index (PII)

Description

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)

Secondary Outcome Measure Information:

Title

Pediatric Quality of Life Inventory (PedsQL)

Description

Time Frame

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)

Title

Center for Epidemiological Studies Depression Scale for Children (CES-DC)

Description

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.

Time Frame

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)

Title

Insomnia Severity Index (ISI)

Description

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.

Time Frame

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).

Title

Psychological Inflexibility in Pain Scale (PIPS)

Description

Time Frame

Other Pre-specified Outcome Measures:

Title

Pain Reactivity Scale - Parent (PRS-P)

Description

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.

Time Frame

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)

Title

Parent Psychological Flexibility Questionnaire (PPFQ)

Description

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.

Time Frame

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)

Title

Patient Health Questionnaire (PHQ-9)

Description

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.

Time Frame

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)

Title

Generalized Anxiety Disorder (GAD-7)

Description

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.

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rikard Wicksell, MD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Institutet

City

Stockholm

ZIP/Postal Code

171 77

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

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Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain

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