Type 1 DiabetesNCT02361606
An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
A study testing An Internet Cognitive-Behavioral Intervention in people with Type 1 Diabetes, run by Dr. Orit Hamiel.
Trial summary
Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- An Internet Cognitive-Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jan 2013
- 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis with diabetes for at least 1 year
- treated at Juvenile Diabetes Center
- fluent Hebrew speakers
Who cannot join
- no previous diagnosis of a psychiatric condition (such as an eating disorder)
- no opposition to the internet due to religious issues.
About this study
Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.
Read the detailed description
Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.
Single center study was conducted to describe participation and efficacy of internet cognitive-behavioral intervention for youth with type 1 diabetes. Adolescents with type 1 diabetes, aged 13-20 years, treated at a Juvenile Diabetes Center, were offered to participate in the intervention. Recruitment period lasted for 2 months, during January-February, 2011.
HbA1c measures of adolescents that agreed to participate, were obtained from medical records.The adolescents, that logged in, were asked to complete questionnaires before the intervention assessing their expectations of the program, quality of life and parental support. After completion of questionnaires, the adolescents were encouraged to complete 6 virtual sessions. Satisfaction was assessed after each session. In the end of the program, participants were asked again to complete questionnaires. HbA1c levels were obtained again for participants that logged in, and for participants that passively refused, 3 months or more after the recruitment.
- Conditions
- Type 1 Diabetes
- Being tested
- An Internet Cognitive-Behavioral Intervention
- Keywords
- adolescents, cognitive behavioral internet intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Internet Cognitive-Behavioral InterventionBehavioural
Also called Minustress For Type 1 Diabetes Program, An Internet CBT for Youth with Type 1 Diabetes
We developed a cognitive behavioral program for adolescents with type 1 Diabetes and their parents, that consists of six virtual sessions at https://minustress.com/diabetes/gate.asp.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT intervention | Experimental | Eligible candidates were offered to participate in an internet cognitive behavioral intervention. Receives: Behavioral: An Internet Cognitive-Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)
Filled in the intervention website.
Measured: Change from baseline to the end of intervention (3 to 6 months from baseline)
Perceived parent support. (Short version of the Social Provision Scale)
Short version of the Social Provision Scale -filled in the intervention website.
Measured: Change from baseline to the end of intervention (3 to 6 monts)
Youth satisfaction of the program. (Questionnaire regarding the degree that the session was helpful.)
Questionnaire regarding the degree that the session was helpful.
Measured: Measured at the end of every virtual session (2 days to 6 months from baseline).
Secondary outcomes (1)
Change in glycemic control. (HbaA1c levels, obtained from medical records)
HbaA1c levels, obtained from medical records twice - the closest measurement available before the trial period, and closest measurement available 3 months or more after the trial period.
Measured: Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Orit Hamiel
- Sponsor type
- Other government
- Collaborators
- Academic College of Tel Aviv-Jaffa, Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor-investigator, Dr. Orit Hamiel, Sheba Medical Center
- Investigators
- Orit Pinhas Hamiel, MD, Study director, Sheba Medical CenterDaniel Hamiel, PhD, Study director, The Interdisciplinary CenterIrena Vusiker, MA, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361606
- Sponsor's protocol ID
- 2009108
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy
- ClinicalTrials.gov ID
- NCT02361606
- Acronym / sponsor ID
- 2009108
- Conditions
- Type 1 Diabetes
- Keywords
- adolescents, cognitive behavioral internet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Dr. Orit HamielOther government
- Collaborators
- Academic College of Tel Aviv-Jaffa, Maccabi Healthcare Services, Israel
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Feb 2015 (estimated)
- 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.
Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.
Detailed description
Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.
Single center study was conducted to describe participation and efficacy of internet cognitive-behavioral intervention for youth with type 1 diabetes. Adolescents with type 1 diabetes, aged 13-20 years, treated at a Juvenile Diabetes Center, were offered to participate in the intervention. Recruitment period lasted for 2 months, during January-February, 2011.
HbA1c measures of adolescents that agreed to participate, were obtained from medical records.The adolescents, that logged in, were asked to complete questionnaires before the intervention assessing their expectations of the program, quality of life and parental support. After completion of questionnaires, the adolescents were encouraged to complete 6 virtual sessions. Satisfaction was assessed after each session. In the end of the program, participants were asked again to complete questionnaires. HbA1c levels were obtained again for participants that logged in, and for participants that passively refused, 3 months or more after the recruitment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet CBT intervention | Experimental | Behavioral: An Internet Cognitive-Behavioral InterventionEligible candidates were offered to participate in an internet cognitive behavioral intervention. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosis with diabetes for at least 1 year
- treated at Juvenile Diabetes Center
- fluent Hebrew speakers
Key exclusion criteria (2 listed)
- no previous diagnosis of a psychiatric condition (such as an eating disorder)
- no opposition to the internet due to religious issues.
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 |
|---|---|---|
| An Internet Cognitive-Behavioral InterventionAlso: Minustress For Type 1 Diabetes Program, An Internet CBT for Youth with Type 1 DiabetesWe developed a cognitive behavioral program for adolescents with type 1 Diabetes and their parents, that consists of six virtual sessions at https://minustress.com/diabetes/gate.asp. | Behavioural | Internet CBT intervention |
Primary outcome
Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)
Time frame: Change from baseline to the end of intervention (3 to 6 months from baseline)
Filled in the intervention website.
Perceived parent support. (Short version of the Social Provision Scale)
Time frame: Change from baseline to the end of intervention (3 to 6 monts)
Short version of the Social Provision Scale -filled in the intervention website.
Youth satisfaction of the program. (Questionnaire regarding the degree that the session was helpful.)
Time frame: Measured at the end of every virtual session (2 days to 6 months from baseline).
Questionnaire regarding the degree that the session was helpful.
1 secondary outcome
Change in glycemic control. (HbaA1c levels, obtained from medical records)
Time frame: Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).
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 12 Feb 2015.
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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.
Orit Pinhas Hamiel, MD study director
Sheba Medical Center
Daniel Hamiel, PhD study director
The Interdisciplinary Center
Irena Vusiker, MA principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing An Internet Cognitive-Behavioral Intervention in people with Type 1 Diabetes, run by Dr. Orit Hamiel.
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 3 inclusion and 2 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire) (time frame: Change from baseline to the end of intervention (3 to 6 months from baseline)). The study lists 3 primary outcomes in all. 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 12 Feb 2015.