DepressionIDEASNCT01040988
The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study
An observational study of Depression and Anxiety, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Depression, Anxiety, Post-traumatic Stress Disorder
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2010
- Phase
- Observational
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients at participating center with pacemakers and ICDs who fit inclusion/exclusion criteria.
Who may be able to join
- Age 6 through 20 at the time of enrollment for patients.
- Age ≥18 for caregiver
- Functioning pacemaker or ICD (explanted or inoperative devices do not qualify)
- Informed consent of parent or guardian as well as assent of study participant
Who cannot join
- Lack of English language fluency in patient and caregiver
- Hospitalization within 4 weeks of visit
- First implantation of ICD or pacemaker within 6 months of study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: The ICD/Device Expectations, Adaptations, and Successes (IDEAS) Study: the Relationship Between Implantable Cardioverter-defibrillators, Pacemakers and Psychiatric Symptoms in a Pediatric Population
The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. In adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. Very few studies have looked at this question in children. We propose to evaluate a cohort of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (PTSD).
- Conditions
- Depression, Anxiety, Post-traumatic Stress Disorder
- Keywords
- Pacemaker, Implantable cardioverter-defibrillator
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker | Patients meeting entry criteria with a pacemaker in place. | |
| ICD | Patients meeting entry criteria with an ICD in place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.
Measured: One-time measure at enrollment
Secondary outcomes (4)
We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).
Measured: One-time at enrollment
We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.
Measured: One-time at enrollment
We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.
Measured: One-time at enrollement
We intend to gather descriptive data on how patients in this age group view their devices.
Measured: One-time at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Principal investigator, David DeMaso, Boston Children's Hospital
- Investigators
- Gregory Webster, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040988
- Sponsor's protocol ID
- X09-04-0195
- Acronym
- IDEAS
- Status last verified
- Apr 2017
- First submitted
- 28 Dec 2009
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
DeMaso DR, Lauretti A, Spieth L, van der Feen JR, Jay KS, Gauvreau K, Walsh EP, Berul CI. Psychosocial factors and quality of life in children and adolescents with implantable cardioverter-defibrillators. Am J Cardiol. 2004 Mar 1;93(5):582-7. doi: 10.1016/j.amjcard.2003.11.022.
PubMed 14996583Webster G, Panek KA, Labella M, Taylor GA, Gauvreau K, Cecchin F, Martuscello M, Walsh EP, Berul CI, DeMaso DR. Psychiatric functioning and quality of life in young patients with cardiac rhythm devices. Pediatrics. 2014 Apr;133(4):e964-72. doi: 10.1542/peds.2013-1394. Epub 2014 Mar 24.
PubMed 24664095
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ICD/Device Expectations, Adaptations, and Successes (IDEAS) Study: the Relationship Between Implantable Cardioverter-defibrillators, Pacemakers and Psychiatric Symptoms in a Pediatric Population
- ClinicalTrials.gov ID
- NCT01040988
- Acronym / sponsor ID
- IDEAS / X09-04-0195
- Conditions
- Depression, Anxiety, Post-traumatic Stress Disorder
- Keywords
- Pacemaker, Implantable cardioverter-defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Dec 2009 (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.
The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. In adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. Very few studies have looked at this question in children. We propose to evaluate a cohort of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (PTSD).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pacemaker | – | –Patients meeting entry criteria with a pacemaker in place. |
| ICD | – | –Patients meeting entry criteria with an ICD in place. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients at participating center with pacemakers and ICDs who fit inclusion/exclusion criteria.
Key inclusion criteria (4 listed)
- Age 6 through 20 at the time of enrollment for patients.
- Age ≥18 for caregiver
- Functioning pacemaker or ICD (explanted or inoperative devices do not qualify)
- Informed consent of parent or guardian as well as assent of study participant
Key exclusion criteria (3 listed)
- Lack of English language fluency in patient and caregiver
- Hospitalization within 4 weeks of visit
- First implantation of ICD or pacemaker within 6 months of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview.
Time frame: One-time measure at enrollment
4 secondary outcomes
We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD).
Time frame: One-time at enrollment
We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker.
Time frame: One-time at enrollment
We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers.
Time frame: One-time at enrollement
We intend to gather descriptive data on how patients in this age group view their devices.
Time frame: One-time at enrollment
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 Apr 2017.
- Background: PubMed 14996583DeMaso DR, Lauretti A, Spieth L, van der Feen JR, Jay KS, Gauvreau K, Walsh EP, Berul CI. Psychosocial factors and quality of life in children and adolescents with implantable cardioverter-defibrillators. Am J Cardiol. 2004 Mar 1;93(5):582-7. doi: 10.1016/j.amjcard.2003.11.022.
- Derived from this study: PubMed 24664095Webster G, Panek KA, Labella M, Taylor GA, Gauvreau K, Cecchin F, Martuscello M, Walsh EP, Berul CI, DeMaso DR. Psychiatric functioning and quality of life in young patients with cardiac rhythm devices. Pediatrics. 2014 Apr;133(4):e964-72. doi: 10.1542/peds.2013-1394. Epub 2014 Mar 24.
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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.
Gregory Webster, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Boston Children's Hospital at 1 site in United States.
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 4 inclusion and 3 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 Apr 2017. 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 United States. 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?
To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview. (time frame: One-time measure at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040988, which also lists 2 linked publications.
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 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.