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

August 12, 2021 updated by: Central Finland Hospital District

Acceptance and Value Based Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes / Hyväksyntä- ja Arvopohjaiset menetelmät Diabetesta Sairastavien Nuorten Hyvinvoinnin edistämisessä

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, 40620
        • Iina Alho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • weekly psychiatric appointments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: research group
Research group is attending the ACT intervention first and from before and afte measurement are compared to the control group
Behavioral: acceptance and commitment therapy, ACT
Active Comparator: control group
Control group is offered to attend the intervention afterwards
Behavioral: acceptance and commitment therapy, ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: up to 8 months
HbA1c
up to 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessed by KINDL-r Questionnaire
Time Frame: up to 8 months
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
Diabetes Related Psychological flexibility assessed by DAAS
Time Frame: up to 8 months
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
Depressive symptoms assessed by RBDI
Time Frame: up to 8 months
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
Psychological flexibility assessed by CAMM
Time Frame: up to 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Finland Hospital District

Collaborators

University of Jyvaskyla
Finnish Diabetes Association

Investigators

  • Study Director: Raimo Lappalainen, PhD, Supervisor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnro 7U/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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