Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
acceptance and commitment therapy, ACT
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes focused on measuring type 1 diabetes, ACT, adolescents, value based methods, acceptance
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes
Exclusion Criteria:
- weekly psychiatric appointments
Sites / Locations
- Iina Alho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
research group
control group
Arm Description
Research group is attending the ACT intervention first and from before and afte measurement are compared to the control group
Control group is offered to attend the intervention afterwards
Outcomes
Primary Outcome Measures
Glycemic control
HbA1c
Secondary Outcome Measures
Quality of life assessed by KINDL-r Questionnaire
To measure the quality of life the Revised Children's Quality of Life Questionnaire is used. The KINDLr is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17 years (Ravens-Sieberer & Bullinger, 1998). In this study, we use the generic, youth-specific, mode of the questionnaire consisting of 24 questions and the diabetes specific module consisting of 17 questions. The answers are given on the Likers Scale from 1-5. The generic mode consists of 6 sub-scales: physical well-being, emotional well-being, self-esteem, social contacts and school. The six sub-scales are combined to form a total score of maximum 120. The maximum score in diabetes specific module is 85. Higher scores indicate better quality of life.
Diabetes Related Psychological flexibility assessed by DAAS
To measure diabetes related acceptance skills the DAAS-questionnaire (The Diabetes Acceptance and Action Scale for Children and Adolescents) is used. A questionnaire is developed to measure the diabetes related psychological flexibility (Greco & Hart, 2005). Questionnaire consists of 42 questions and responses are given on Likert scale from 0-4. The maximum score in the questionnaire is 168. The higher sum in the questionnaire refers to higher psychological flexibility, better acceptance of diabetes and action.
Depressive symptoms assessed by RBDI
To measure the depressive symptoms and anxiety the RBDI-questionnaire (Revised Beck Depression Inventory) is used. RBDI is a Finnish version of The Beck Depression Inventory (Beck & Beck, 1972). It consists of 13 questions measuring depressive symptoms and one question measuring anxiety. In each question there are five possible answers to choose and scores are given from 0 to 3. The maximum score for measuring depressive symptoms is 39 and the maximum score for the question measuring anxiety is 3. Higher scores means more symptoms of depression or anxiety.
Psychological flexibility assessed by CAMM
To asses psychological flexibility CAMM (The Child and Adolescent Mindfulness measure) is used. CAMM-questionnaire was developed to measure the mindfulness and acceptance skills and it assesses the degree to which children and adolescents observe internal experiences, act with awareness, and accept internal experiences without judging them (Greco, Baer, & Smith, 2011). The 10-question version is used. The answers are given on Likert scale 0-4, from never true to always true. Maximum score is 40. Higher scores indicate higher levels of mindfulness and acceptance.
Full Information
NCT ID
NCT03825562
First Posted
January 30, 2017
Last Updated
August 12, 2021
Sponsor
Central Finland Hospital District
Collaborators
University of Jyvaskyla, Finnish Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT03825562
Brief Title
Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
Official Title
Acceptance and Value Based Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes / Hyväksyntä- ja Arvopohjaiset menetelmät Diabetesta Sairastavien Nuorten Hyvinvoinnin edistämisessä
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Finland Hospital District
Collaborators
University of Jyvaskyla, Finnish Diabetes Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to study how using acceptance and value based group intervention helps the wellbeing of teenagers with type in diabetes.
The investigators created an ACT-group intervention consisting of five sessions, based on earlier research. 12-16 years- old diabetics who are treated at KSSHP pediatric policlinic are invited to join the groups. The participants are randomized to research and control groups. The HbA1c-level is monitored for both groups as well as the psychological flexibility, diabetes related acceptance, depression and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
type 1 diabetes, ACT, adolescents, value based methods, acceptance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
research group
Arm Type
Experimental
Arm Description
Research group is attending the ACT intervention first and from before and afte measurement are compared to the control group
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Control group is offered to attend the intervention afterwards
Intervention Type
Behavioral
Intervention Name(s)
acceptance and commitment therapy, ACT
Primary Outcome Measure Information:
Title
Glycemic control
Description
HbA1c
Time Frame
up to 8 months
Secondary Outcome Measure Information:
Title
Quality of life assessed by KINDL-r Questionnaire
Description
To measure the quality of life the Revised Children's Quality of Life Questionnaire is used. The KINDLr is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17 years (Ravens-Sieberer & Bullinger, 1998). In this study, we use the generic, youth-specific, mode of the questionnaire consisting of 24 questions and the diabetes specific module consisting of 17 questions. The answers are given on the Likers Scale from 1-5. The generic mode consists of 6 sub-scales: physical well-being, emotional well-being, self-esteem, social contacts and school. The six sub-scales are combined to form a total score of maximum 120. The maximum score in diabetes specific module is 85. Higher scores indicate better quality of life.
Time Frame
up to 8 months
Title
Diabetes Related Psychological flexibility assessed by DAAS
Description
To measure diabetes related acceptance skills the DAAS-questionnaire (The Diabetes Acceptance and Action Scale for Children and Adolescents) is used. A questionnaire is developed to measure the diabetes related psychological flexibility (Greco & Hart, 2005). Questionnaire consists of 42 questions and responses are given on Likert scale from 0-4. The maximum score in the questionnaire is 168. The higher sum in the questionnaire refers to higher psychological flexibility, better acceptance of diabetes and action.
Time Frame
up to 8 months
Title
Depressive symptoms assessed by RBDI
Description
To measure the depressive symptoms and anxiety the RBDI-questionnaire (Revised Beck Depression Inventory) is used. RBDI is a Finnish version of The Beck Depression Inventory (Beck & Beck, 1972). It consists of 13 questions measuring depressive symptoms and one question measuring anxiety. In each question there are five possible answers to choose and scores are given from 0 to 3. The maximum score for measuring depressive symptoms is 39 and the maximum score for the question measuring anxiety is 3. Higher scores means more symptoms of depression or anxiety.
Time Frame
up to 8 months
Title
Psychological flexibility assessed by CAMM
Description
To asses psychological flexibility CAMM (The Child and Adolescent Mindfulness measure) is used. CAMM-questionnaire was developed to measure the mindfulness and acceptance skills and it assesses the degree to which children and adolescents observe internal experiences, act with awareness, and accept internal experiences without judging them (Greco, Baer, & Smith, 2011). The 10-question version is used. The answers are given on Likert scale 0-4, from never true to always true. Maximum score is 40. Higher scores indicate higher levels of mindfulness and acceptance.
Time Frame
up to 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes
Exclusion Criteria:
weekly psychiatric appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimo Lappalainen, PhD
Organizational Affiliation
supervisor
Official's Role
Study Director
Facility Information:
Facility Name
Iina Alho
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
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