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

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ClinicalTrials.gov Identifier: NCT03825562
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
University of Jyvaskyla
Finnish Diabetes Association
Information provided by (Responsible Party):
Central Finland Hospital District

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: acceptance and commitment therapy, ACT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : October 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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



Primary Outcome Measures :
  1. Glycemic control [ Time Frame: up to 8 months ]
    HbA1c


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • weekly psychiatric appointments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825562


Contacts
Contact: Iina Alho, MA Psych 00358500629372 iina.alho@ksshp.fi

Locations
Finland
Iina Alho Recruiting
Jyväskylä, Finland, 40620
Sponsors and Collaborators
Central Finland Hospital District
University of Jyvaskyla
Finnish Diabetes Association
Investigators
Study Director: Raimo Lappalainen, PhD supervisor

Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT03825562     History of Changes
Other Study ID Numbers: Dnro 7U/2015
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Finland Hospital District:
type 1 diabetes
ACT
adolescents
value based methods
acceptance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases