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

Sponsor
Central Finland Hospital District (Other)
Overall Status
Completed
CT.gov ID
NCT03825562
Collaborator
University of Jyvaskyla (Other), Finnish Diabetes Association (Other)
60
1
2
67
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: acceptance and commitment therapy, ACT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 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 :
Oct 1, 2015
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Glycemic control [up to 8 months]

    HbA1c

Secondary Outcome Measures

  1. Quality of life assessed by KINDL-r Questionnaire [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • type 1 diabetes
Exclusion Criteria:
  • weekly psychiatric appointments

Contacts and Locations

Locations

Site City State Country Postal Code
1 Iina Alho Jyväskylä Finland 40620

Sponsors and Collaborators

  • Central Finland Hospital District
  • University of Jyvaskyla
  • Finnish Diabetes Association

Investigators

  • Study Director: Raimo Lappalainen, PhD, supervisor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Finland Hospital District
ClinicalTrials.gov Identifier:
NCT03825562
Other Study ID Numbers:
  • Dnro 7U/2015
First Posted:
Jan 31, 2019
Last Update Posted:
Aug 13, 2021
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Central Finland Hospital District
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021