Inflammatory Bowel DiseaseNCT02740309
Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems
A study testing Integrated Brief Behavior Therapy (IBBT) Intervention and Treatment as usual in people with Inflammatory Bowel Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Integrated Brief Behavior Therapy (IBBT) Intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2018
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms and includes youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness.
Who cannot join
- Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sala Institute for Child and Family Centered Care
New York, New York, 10016
About this study
Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Integrated Brief Behavior Therapy (IBBT) Intervention, Treatment as usual
- Keywords
- inflammatory bowel disease, childhood chronic disease, adolescent depression, adolescent anxiety, integrated brief behavioral therapy, adolescent psychosocial risks, adolescent chronic disease, childhood depression, childhood anxiety, childhood psychosocial risks
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Brief Behavior Therapy (IBBT) InterventionBehavioural
The 4 sessions will empower and support families and youth to continue treatment autonomously with home practice
Treatment as usualBehavioural
Facilitated community referral for mental health treatment
| Study group | Role | What they receive |
|---|---|---|
| Integrated Brief Behavior Therapy (IBBT) Intervention | Experimental | 4-sessions of IBBT for youth anxiety and depression. Receives: Behavioral: Integrated Brief Behavior Therapy (IBBT) Intervention |
| Treatment as usual | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety and/or Depression Symptoms
Anxiety and depression symptoms are hypothesized to decrease more in the IBBT-4 group and psychosocial functioning is hypothesized to improve more in the IBBT-4 group as compared to TAU. The number of patients who no longer meet criteria for depression and/or anxiety after brief intervention is hypothesized to be greater than as compared to TAU. The Patient Health Questionnaire (PHQ-9) will be repeated self-report measures of depression and anxiety symptoms at each time point to assess symptomatology.The PHQ-9 consists of 9 questions scored 0-3, with 3 denoting the early every day ( highest value).
Measured: 1 year ( baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Treatment Engagement at Baseline
One visit is the modal number of encounters for patients seeking treatment in the community mental health care settings. The investigators hypothesize that by implementing an integrated behavioral health model that identifies mental health issues in medical settings as part of routine care and engages individuals in on-site treatment for depression and anxiety will increase the number of completed mental health encounters utilized and the number of successful referrals to community mental health providers when ongoing treatment is needed.
Multiple measurements will be aggregated to arrive at 1 reported value.Data will be collected by tracking the number of sessions attended for IBBT-4 vs. the number of sessions attended for the treatment as usual group at 8 weeks post initial assessment as well as whether or not referrals to community mental health providers are successfully completed by either group at each time point.
Measured: 1 year
Screen for Childhood Anxiety Related Emotional Disorders (SCARED)
The SCARED will be repeated self-report measures of anxiety symptoms at each time point to assess symptomatology. SCARED is a 41-item screening tool with each scored from 0 to 2, with 2 denoting "very true or often true" (highest value). Total scores of 25 or greater indicate the presence of an Anxiety Disorder. Subscore cut off ranges are also provided for Panic Disorder or Significant Somatic Symptoms, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety, and School Avoidance.
Measured: 1 year
Children's Global Assessment Scale (CGAS)
A Children's Global Assessment Scale (CGAS) will also be completed at baseline and at each time point for global psychosocial functioning.C-GAS is rated from 0 to 100, where 1 represents the most impaired functioning and 100 represents superior functioning.
Measured: 1 year
Columbia Suicide Severity Rating Scale (C-SSRS)
At baseline screening, the Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for suicidal ideation or actions.CSSRS consists of ten categories and have binary responses (yes/no). A "yes" answer at any time during treatment to Categories 1-5 is defined as suicidal ideation. A "yes" answer at any time during treatment to Categories 6-10 is defined as suicidal behavior. A "yes" answer to any one of the ten suicidal ideation and behavior questions at any time during treatment to (Categories 1-10) is defined as suicidal ideation or behavior.
Measured: 1 year
Secondary outcomes (6)
IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)
IBD disease activity will be assessed through validated Pediatric Ulcerative Colitis Activity Index (PUCAI) which measure symptom severity in a given time period through physician, laboratory, and subjective self-report markers of disease activity. These measures will be assessed at each time point. PUCAI score ranges from 0 to 85; a score of < 10 denotes remission, 10-34 indicates mild disease, 35-64 indicates moderate disease, and 65-85 indicates severe disease.
Measured: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
IBD-related quality of life-SIBDQ
IBD-related quality of life will be measured by the Short Quality of Life Questionnaire for Inflammatory Bowel Disease (SIBDQ).
Measured: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Medical Adherence Measure
Medical Treatment Adherence will be measured by the Medical Adherence Measure (MAM).
Measured: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Health Care Utilization
Health care utilization will be measured by outpatient and emergency room visits and inpatient hospitalizations collected through medical record review and participant self-report.
Measured: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Pediatric Crohn's Disease Activity Index (PCDAI)
IBD disease activity will be assessed through validated Pediatric Crohn's Disease Activity Index (PCDAI) which measure symptom severity in a given time period through physician, laboratory, and subjective self-report markers of disease activity.The PCDAI has hematocrit, Albumin and ESR as markers:ESR: 0-20 mm/hr, Albumin: 3.5 - 5.0 gm/dL, HCT: 35-47%. As for the disease indicators: PCDAI score can range from 0-100, with higher scores signifying more active disease. A score of < 10 is consistent with inactive disease, 11-30 indicates mild disease, and > 30 is moderate-to-severe disease.
Measured: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Health Care Cost
Health Care costs will be measured by outpatient and emergency room visits and inpatient hospitalizations collected through medical record review and participant self-report.
Measured: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: PI left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K. Ron-Li Liaw, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740309
- Sponsor's protocol ID
- 15-01065
- Status last verified
- Dec 2018
- First submitted
- 24 Feb 2016
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems
- ClinicalTrials.gov ID
- NCT02740309
- Acronym / sponsor ID
- 15-01065
- Conditions
- Inflammatory Bowel Disease
- Keywords
- inflammatory bowel disease, childhood chronic disease, adolescent depression, adolescent anxiety, integrated brief behavioral therapy, adolescent psychosocial risks, adolescent chronic disease, childhood depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Apr 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.
Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Brief Behavior Therapy (IBBT) Intervention | Experimental | Behavioral: Integrated Brief Behavior Therapy (IBBT) Intervention4-sessions of IBBT for youth anxiety and depression. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms and includes youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay.
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 |
|---|---|---|
| Integrated Brief Behavior Therapy (IBBT) InterventionThe 4 sessions will empower and support families and youth to continue treatment autonomously with home practice | Behavioural | Integrated Brief Behavior Therapy (IBBT) Intervention |
| Treatment as usualFacilitated community referral for mental health treatment | Behavioural | Treatment as usual |
Primary outcome
Change in Anxiety and/or Depression Symptoms
Time frame: 1 year ( baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Anxiety and depression symptoms are hypothesized to decrease more in the IBBT-4 group and psychosocial functioning is hypothesized to improve more in the IBBT-4 group as compared to TAU. The number of patients who no longer meet criteria for depression and/or anxiety after brief intervention is hypothesized to be greater than as compared to TAU. The Patient Health Questionnaire (PHQ-9) will be repeated self-report measures of depression and anxiety symptoms at each time point to assess symptomatology.The PHQ-9 consists of 9 questions scored 0-3, with 3 denoting the early every day ( highest value).
Treatment Engagement at Baseline
Time frame: 1 year
One visit is the modal number of encounters for patients seeking treatment in the community mental health care settings. The investigators hypothesize that by implementing an integrated behavioral health model that identifies mental health issues in medical settings as part of routine care and engages individuals in on-site treatment for depression and anxiety will increase the number of completed mental health encounters utilized and the number of successful referrals to community mental health providers when ongoing treatment is needed. Multiple measurements will be aggregated to arrive at 1 reported value.Data will be collected by tracking the number of sessions attended for IBBT-4 vs. the number of sessions attended for the treatment as usual group at 8 weeks post initial assessment as well as whether or not referrals to community mental health providers are successfully completed by either group at each time point.
Screen for Childhood Anxiety Related Emotional Disorders (SCARED)
Time frame: 1 year
The SCARED will be repeated self-report measures of anxiety symptoms at each time point to assess symptomatology. SCARED is a 41-item screening tool with each scored from 0 to 2, with 2 denoting "very true or often true" (highest value). Total scores of 25 or greater indicate the presence of an Anxiety Disorder. Subscore cut off ranges are also provided for Panic Disorder or Significant Somatic Symptoms, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety, and School Avoidance.
Children's Global Assessment Scale (CGAS)
Time frame: 1 year
A Children's Global Assessment Scale (CGAS) will also be completed at baseline and at each time point for global psychosocial functioning.C-GAS is rated from 0 to 100, where 1 represents the most impaired functioning and 100 represents superior functioning.
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 1 year
At baseline screening, the Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for suicidal ideation or actions.CSSRS consists of ten categories and have binary responses (yes/no). A "yes" answer at any time during treatment to Categories 1-5 is defined as suicidal ideation. A "yes" answer at any time during treatment to Categories 6-10 is defined as suicidal behavior. A "yes" answer to any one of the ten suicidal ideation and behavior questions at any time during treatment to (Categories 1-10) is defined as suicidal ideation or behavior.
6 secondary outcomes
IBD disease activity - Pediatric Ulcerative Colitis Activity Index (PUCAI)
Time frame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
IBD-related quality of life-SIBDQ
Time frame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Medical Adherence Measure
Time frame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Health Care Utilization
Time frame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Pediatric Crohn's Disease Activity Index (PCDAI)
Time frame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Health Care Cost
Time frame: 1 year ( Data will be collected at 4 time points: baseline, 8-12 weeks, 6 months, and 12 months post baseline)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- 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.
K. Ron-Li Liaw, MD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Brief Behavior Therapy (IBBT) Intervention and Treatment as usual in people with Inflammatory Bowel Disease, run by NYU Langone Health 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: withdrawn, as of the sponsor's last update on 5 Dec 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 Anxiety and/or Depression Symptoms (time frame: 1 year ( baseline, 8-12 weeks, 6 months, and 12 months post baseline)). The study lists 5 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 5 Dec 2018.