AnxietyDECADESNCT02773706
Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties
A study testing Automated Psychology Services and Notification of Subspecialist in people with Anxiety and Depression, run by Indiana University at 1 site in United States.
Trial summary
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Automated Psychology Services and Notification of Subspecialist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 1 Nov 2019
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care.
Who cannot join
- Patients over the age of 18 or under the age of 10.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health North Hospital
Carmel, Indiana, 46074
About this study
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.
Read the detailed description
SPECIFIC AIMS: Mental Health and Quality of Life in Children with Gastrointestinal Disorders Depression and anxiety are two of the most common and dangerous disorders in childhood and adolescence. Currently, a large proportion of children with these disorders remain unrecognized or untreated resulting in considerable morbidity and mortality. The rates of depression and anxiety are significantly higher in children with chronic illnesses, including gastrointestinal disorders, than in the general population. Furthermore, children with depression or anxiety are far more likely to have somatic complaints, and have greater utilization of subspecialty care, especially in gastroenterology. Functional gastrointestinal disorders such as irritable bowel syndrome, chronic recurrent abdominal pain, and functional dyspepsia frequently have comorbid anxiety or depression.
Efforts to recognize and treat mental health problems in children with chronic medical illness, such as gastrointestinal disorders, have been shown to improve adherence to therapy, as well as other clinical outcomes. More importantly, improving such mental health problems might go far to addressing the outcomes patients care about most with respect to their gastroenterological disease. Unfortunately, mental health resources are often difficult for families to access, even when these disorders are recognized.
Validated screening tools exist to screen for anxiety and depression in children and adolescents, including the Screen for Childhood Anxiety Related Emotional Disorders (SCARED) and the Patient Health Questionnaire (PHQ-9). Despite the established importance of depression and anxiety in the gastrointestinal health of children and adolescents, few data exist describing the treatment of anxiety and depression by pediatric gastroenterologists. Furthermore, little is known about how families or patients view the subspecialty office as the setting to detect or care for mental illness. Additionally, if anxiety and depression are identified by the gastroenterologist, many practitioners find either they have limited training and expertise in the management of adolescent mental health disorders, or they encounter barriers to referral to a mental health specialist, especially in children with public insurance.
Therefore, the specific aims of this research project are to:
Aim 1: Determine family and patient attitudes towards tools to screen for mental illness in a pediatric subspecialty office utilizing structured interviews.
Sub Aim 1a: Determine patient and family attitudes toward anxiety and depression screening in a subspecialty office.
Sub Aim 1b: Determine outcomes of importance to patients and families related to anxiety and depression in a pediatric subspecialty office.
Aim 2: Develop an integrated approach that accounts for family and patient preferences as determined in Aim 1, to deliver anxiety and depression screening instruments to new and established patients in a pediatric gastroenterology clinic.
Aim 3: Perform a pre-post comparative effectiveness trial comparing screening in a pediatric gastroenterological clinic with notification of the physician to screening in a pediatric gastroenterological clinic with the addition of a psychologist, with respect to the patient-centered outcomes identified in Aim 1.
Completion of these aims will allow the investigators to develop an integrated process to screen for depression and anxiety in a high-risk population. Furthermore, the knowledge gained from piloting depression and anxiety screening will help the investigators to determine attitudes towards this approach in the pediatric subspecialty setting, which will maximize outcomes from the visit that are important to patients and their families.
The investigators hypothesize that a combined approach that screens for depression and anxiety within the gastroenterology clinic and also provides for access to a psychologist who is integrated with the clinic will lead to superior clinical and patient-centered outcomes. However the investigators may find that screening patients and then alerting the gastroenterology provider may be sufficient to recognize and treat mental health disorders effectively. Comparing the effectiveness of these two strategies is therefore important and is the overall focus of this proposal.
- Conditions
- Anxiety, Depression
- Being tested
- Automated Psychology Services, Notification of Subspecialist
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Psychology ServicesOther
The automated screening tool determines a positive or negative screen, then informs the clinician, and also automates a psychology visit.
Notification of SubspecialistOther
The automated screening tool determines a positive or negative screen, then informs the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Subspecialty Care | Experimental | Once a subject is screened positive for anxiety or depression, the subspecialty provider is informed of the positive screen, and left to manage or refer the condition as per usual care by that provider.
Intervention: Depression / anxiety screen + clinician informed. Receives: Other: Notification of Subspecialist |
| Integrated Psychology Care | Active comparator | Once a subject is screened positive for anxiety or depression, an automated psychology referral occurs, in addition to any intervention determined by the subspecialty provider.
Intervention: Depression / anxiety screen + clinician informed + automated psychologist visit. Receives: Other: Automated Psychology Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (baseline)
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures.
PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
Measured: Baseline
Quality of life (followup)
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures.
PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
Measured: Within 6 months
Secondary outcomes (5)
Utilization of endoscopy
The investigators will compare the use of endoscopy, radiologic testing, laboratory testing, emergency department utilization, and repeat gastroenterology outpatient visits. Frequency of each of these will be compared between control and intervention arms.
Measured: Within 6 months
Utilization of radiologic testing
The electronic medical record will be queried by the RA and the total number of radiologic tests ordered over 6 months will be computed.
Measured: 6 months
Utilization of laboratory testing
The electronic medical record will be queried by the RA and the total number of laboratory tests ordered over 6 months will be computed.
Measured: 6 months
Utilization of emergency department visits
The electronic medical record will be queried by the RA and the total number of emergency department visits over 6 months will be computed.
Measured: 6 months
Utilization of outpatient gastroenterology
The electronic medical record will be queried by the RA and the total number of outpatient gastroenterology visits over 6 months will be computed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start18 Dec 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, William E. Bennett, Jr., Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773706
- Sponsor's protocol ID
- DECADES
- Acronym
- DECADES
- Status last verified
- Aug 2022
- First submitted
- 19 Jun 2015
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties
- ClinicalTrials.gov ID
- NCT02773706
- Acronym / sponsor ID
- DECADES / DECADES
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 16 May 2016 (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 DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.
Detailed description
SPECIFIC AIMS: Mental Health and Quality of Life in Children with Gastrointestinal Disorders Depression and anxiety are two of the most common and dangerous disorders in childhood and adolescence. Currently, a large proportion of children with these disorders remain unrecognized or untreated resulting in considerable morbidity and mortality. The rates of depression and anxiety are significantly higher in children with chronic illnesses, including gastrointestinal disorders, than in the general population. Furthermore, children with depression or anxiety are far more likely to have somatic complaints, and have greater utilization of subspecialty care, especially in gastroenterology. Functional gastrointestinal disorders such as irritable bowel syndrome, chronic recurrent abdominal pain, and functional dyspepsia frequently have comorbid anxiety or depression.
Efforts to recognize and treat mental health problems in children with chronic medical illness, such as gastrointestinal disorders, have been shown to improve adherence to therapy, as well as other clinical outcomes. More importantly, improving such mental health problems might go far to addressing the outcomes patients care about most with respect to their gastroenterological disease. Unfortunately, mental health resources are often difficult for families to access, even when these disorders are recognized.
Validated screening tools exist to screen for anxiety and depression in children and adolescents, including the Screen for Childhood Anxiety Related Emotional Disorders (SCARED) and the Patient Health Questionnaire (PHQ-9). Despite the established importance of depression and anxiety in the gastrointestinal health of children and adolescents, few data exist describing the treatment of anxiety and depression by pediatric gastroenterologists. Furthermore, little is known about how families or patients view the subspecialty office as the setting to detect or care for mental illness. Additionally, if anxiety and depression are identified by the gastroenterologist, many practitioners find either they have limited training and expertise in the management of adolescent mental health disorders, or they encounter barriers to referral to a mental health specialist, especially in children with public insurance.
Therefore, the specific aims of this research project are to:
Aim 1: Determine family and patient attitudes towards tools to screen for mental illness in a pediatric subspecialty office utilizing structured interviews.
Sub Aim 1a: Determine patient and family attitudes toward anxiety and depression screening in a subspecialty office.
Sub Aim 1b: Determine outcomes of importance to patients and families related to anxiety and depression in a pediatric subspecialty office.
Aim 2: Develop an integrated approach that accounts for family and patient preferences as determined in Aim 1, to deliver anxiety and depression screening instruments to new and established patients in a pediatric gastroenterology clinic.
Aim 3: Perform a pre-post comparative effectiveness trial comparing screening in a pediatric gastroenterological clinic with notification of the physician to screening in a pediatric gastroenterological clinic with the addition of a psychologist, with respect to the patient-centered outcomes identified in Aim 1.
Completion of these aims will allow the investigators to develop an integrated process to screen for depression and anxiety in a high-risk population. Furthermore, the knowledge gained from piloting depression and anxiety screening will help the investigators to determine attitudes towards this approach in the pediatric subspecialty setting, which will maximize outcomes from the visit that are important to patients and their families.
The investigators hypothesize that a combined approach that screens for depression and anxiety within the gastroenterology clinic and also provides for access to a psychologist who is integrated with the clinic will lead to superior clinical and patient-centered outcomes. However the investigators may find that screening patients and then alerting the gastroenterology provider may be sufficient to recognize and treat mental health disorders effectively. Comparing the effectiveness of these two strategies is therefore important and is the overall focus of this proposal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Subspecialty Care | Experimental | Other: Notification of SubspecialistOnce a subject is screened positive for anxiety or depression, the subspecialty provider is informed of the positive screen, and left to manage or refer the condition as per usual care by that provider. Intervention: Depression / anxiety screen + clinician informed. |
| Integrated Psychology Care | Active comparator | Other: Automated Psychology ServicesOnce a subject is screened positive for anxiety or depression, an automated psychology referral occurs, in addition to any intervention determined by the subspecialty provider. Intervention: Depression / anxiety screen + clinician informed + automated psychologist visit. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care.
Key exclusion criteria (1 listed)
- Patients over the age of 18 or under the age of 10.
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 |
|---|---|---|
| Automated Psychology ServicesThe automated screening tool determines a positive or negative screen, then informs the clinician, and also automates a psychology visit. | Other | Integrated Psychology Care |
| Notification of SubspecialistThe automated screening tool determines a positive or negative screen, then informs the clinician. | Other | Usual Subspecialty Care |
Primary outcome
Quality of life (baseline)
Time frame: Baseline
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
Quality of life (followup)
Time frame: Within 6 months
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
5 secondary outcomes
Utilization of endoscopy
Time frame: Within 6 months
Utilization of radiologic testing
Time frame: 6 months
Utilization of laboratory testing
Time frame: 6 months
Utilization of emergency department visits
Time frame: 6 months
Utilization of outpatient gastroenterology
Time frame: 6 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 23 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Psychology Services and Notification of Subspecialist in people with Anxiety and Depression, run by Indiana University 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 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 23 Aug 2022. 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?
Quality of life (baseline) (time frame: Baseline). The study lists 2 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 23 Aug 2022.