Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825562
• Other study ID #: Dnro 7U/2015
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2021

Study information

• Verified date: May 2019
• Source: Central Finland Hospital District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes

Exclusion Criteria:

• weekly psychiatric appointments

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• acceptance and commitment therapy, ACT

Locations

Country	Name	City	State
Finland	Iina Alho	Jyväskylä

Sponsors (3)

Lead Sponsor	Collaborator
Central Finland Hospital District	Finnish Diabetes Association, University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	HbA1c	up to 8 months
Secondary	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.	up to 8 months
Secondary	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.	up to 8 months
Secondary	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.	up to 8 months
Secondary	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.	up to 8 months