DiabetesNCT03825562
Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
A study testing acceptance and commitment therapy, ACT in people with Diabetes, run by Central Finland Hospital District at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Diabetes
- What is being tested?
- acceptance and commitment therapy, ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- type 1 diabetes
Who cannot join
- weekly psychiatric appointments
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Diabetes
- Being tested
- acceptance and commitment therapy, ACT
- Keywords
- type 1 diabetes, ACT, adolescents, value based methods, acceptance
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acceptance and commitment therapy, ACTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | Research group is attending the ACT intervention first and from before and afte measurement are compared to the control group Receives: Behavioral: acceptance and commitment therapy, ACT |
| control group | Active comparator | Control group is offered to attend the intervention afterwards Receives: Behavioral: acceptance and commitment therapy, ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
HbA1c
Measured: up to 8 months
Secondary outcomes (4)
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.
Measured: up to 8 months
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.
Measured: up to 8 months
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.
Measured: up to 8 months
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.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study startOct 2015
- Primary completionMay 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jyvaskyla, Finnish Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Raimo Lappalainen, PhD, Study director, supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825562
- Sponsor's protocol ID
- Dnro 7U/2015
- Status last verified
- May 2019
- First submitted
- 30 Jan 2017
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03825562
- Acronym / sponsor ID
- Dnro 7U/2015
- Conditions
- Diabetes
- Keywords
- type 1 diabetes, ACT, adolescents, value based methods, acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Collaborators
- University of Jyvaskyla, Finnish Diabetes Association
- Study start
- Oct 2015
- Primary completion
- May 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Behavioral: acceptance and commitment therapy, ACTResearch group is attending the ACT intervention first and from before and afte measurement are compared to the control group |
| control group | Active comparator | Behavioral: acceptance and commitment therapy, ACTControl group is offered to attend the intervention afterwards |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- type 1 diabetes
Key exclusion criteria (1 listed)
- weekly psychiatric appointments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acceptance and commitment therapy, ACT | Behavioural | control group, research group |
Primary outcome
Glycemic control
Time frame: up to 8 months
HbA1c
4 secondary outcomes
Quality of life assessed by KINDL-r Questionnaire
Time frame: up to 8 months
Diabetes Related Psychological flexibility assessed by DAAS
Time frame: up to 8 months
Depressive symptoms assessed by RBDI
Time frame: up to 8 months
Psychological flexibility assessed by CAMM
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raimo Lappalainen, PhD study director
supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acceptance and commitment therapy, ACT in people with Diabetes, run by Central Finland Hospital District at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.