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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT02773706
Study groupRoleWhat they receive
Usual Subspecialty CareExperimentalOnce 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 CareActive comparatorOnce 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted16 May 2016 (estimated)
  2. Study start18 Dec 2017
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2019

Resources

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)
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

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.

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