AnxietyNCT04025190
Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population
An observational study of Anxiety and Depression, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary purpose of this study is twofold: (1) to assess the feasibility of screening adult hematopoietic stem cell transplantation (HSCT) candidates for psychiatric comorbidity (depression and anxiety), and (2) to assess the feasibility of treating depression and anxiety in adult HSCT candidates through a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2018to 28 Aug 2018
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients were English speaking adults (age >18 years) with hematological or non-hematological malignancy with an indication to undergo allogeneic HSCT, who were scheduled to undergo allogeneic transplant within 30 days of enrollment, had a scheduled Pre-Transplant Admission clinic visit at the ambulatory HSCT clinic, and were able to complete self-report measures. Patients were excluded if they were pregnant, unable to complete self-report measures in English, or had pre-existing diagnoses of bipolar affective disorder, schizoaffective disorder or schizophrenia.
Who may be able to join
- hematological or non-hematological malignancy
- plan to receive an allogeneic stem cell transplant
- patient at UNC's ambulatory BMT clinic
- able to complete self-report measures
- English speaking
Who cannot join
- plan to receive an autologous transplant
- plan to receive allogeneic transplant for a non-malignancy
- unable to complete self report measures in English
- pregnant
- pre-existing diagnoses of bipolar affective disorder, schizoaffective disorder or schizophrenia
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is twofold: (1) to assess the feasibility of screening adult hematopoietic stem cell transplantation (HSCT) candidates for psychiatric comorbidity (depression and anxiety), and (2) to assess the feasibility of treating depression and anxiety in adult HSCT candidates through a collaborative care algorithm. The ultimate goal of this project is improving HSCT outcomes for allogeneic HSCT candidates by improving identification and treatment of depression and anxiety disorders.
Read the detailed description
Enrollment and depression and anxiety symptom screening:
All patients who are candidates for allogeneic transplantation and have a scheduled "Pre-Admission Visit" at UNC will be screened by study team to assess if they are eligible for participation. At their "Pre-Admission Visit" patients will be approached for enrollment in the study. Patients who provide written informed consent will complete the Hospital Anxiety and Depression Scale (HADS) survey at that time. If patients screen positive on the HADS (meaning a score of 8 or greater in the anxiety or the depression sections), they will be offered treatment within a collaborative care model intervention. If patients score less than 8 on the HADS survey (negative for symptoms of anxiety or depression) at the Pre-Admission Visit, they will not be offered treatment on study. Their medical records will still be abstracted periodically to follow post-transplant outcomes.
The Collaborative Care Model:
The collaborative care model is a team-delivered treatment program and will be provided by a treatment team of HSCT advanced practice providers (APP), HSCT physician, Comprehensive Cancer Support Program (CCSP) clinicians, and a psychiatrist. The collaborative care treatment intervention will be offered if patients score positive (score of 8 or greater) on the HADS. The collaborative care intervention includes medication consideration, therapy evaluation, and referral to psychiatry if needed.
Treatment Options in the Collaborative Care Model:
There will be three treatment options in the collaborative care model that will be offered to patients who score 8 or greater on the HADS - pharmacologic therapy, non-pharmacologic therapy, or both. If a patient chooses to start pharmacologic therapy after discussion with the APP at the Pre-Admission Visit, this treatment will include one of two antidepressants, which are standard-of-care treatments in medicine. The nonpharmacologic treatment in the Collaborative Care Model will involve a therapy consultation by the CCSP once patient is admitted to the hospital for their HSCT. Patients can also opt to take part in therapy with CCSP as well as taking medications.
The study team at the time of enrollment will gather patient demographics and clinical information including gender, age, disease type, donor HLA match, and history of mental health disorders from the medical record.
Follow-up HADS Surveys:
On Day 0, (day of stem cell infusion) to the hospital for HSCT, patients will undergo another HADS survey, and this will be repeated at Day +14 (+/- 3 days), Day +30 (+/- 3 days), and Day +60 (+/- 3 days). Information will be gathered from the medical records on Day +14, Day +30, and Day +60 regarding symptoms of mucositis, inability to tolerate oral medications, development of hospital-acquired illnesses, ICU admissions, reactivation of viruses (i.e. CMV), readmission to hospital, engraftment status, development of GVHD, and missed clinic appointments.
During the course of the study, all cases will be reviewed weekly in meetings with the psychiatrist and HSCT APPs to address mood symptoms, evaluate the need for titration of medications, and evaluate the need for psychotherapy, provided by CCSP therapist or psychiatrist.
Satisfaction Surveys:
At six months from initial patient enrollment, satisfaction surveys will be distributed to the HSCT APPs and HSCT physicians who have taken part in the study. Each patient at the end of study will also complete a satisfaction survey.
- Conditions
- Anxiety, Depression
- Keywords
- anxiety, depression, collaborative care, psycho-oncology, bone marrow transplant
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Transplant | All patients seen in the UNC Bone Marrow Transplant clinic who are candidates for allogeneic transplantation attending their pre-admission visit were approached to offer study participation. Study participation included completion of surveys over a time period up to 60 days after their transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale
Assess the feasibility of systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale in adult patients who are allogeneic HSCT candidates.
Measured: Day 0
Secondary outcomes (3)
Satisfaction among patients and providers participating in the collaborative care model
Assess the feasibility of implementing a collaborative care model through assessment of intervention satisfaction scores among participating patients and their health care providers.
Measured: Day 0
Severity of post-transplant outcomes as defined by an investigator-designed post-transplant outcome index in relation to Hospital Anxiety and Depression Scale scores
Explore an association between an investigator-designed post-transplant outcome index (listed below) in patients undergoing allogeneic transplantation and Hospital Anxiety and Depression Scale scores. Aggregated outcomes abstracted from the medical record included: (a) number of days spent in hospital during transplant admission, (b) number of missed clinic appointments, (c) development of acute GVHD, (d) development of chronic GVHD, (e) admission to ICU within first 100 days of transplant, (f) date of neutrophil engraftment, (g) frequency of viral reactivation requiring antiviral treatment, and (h) death in the first 100 days.
Measured: Day 0
Change in anxiety or depression as measured by the Hospital Anxiety and Depression Scale.
Explore whether patient's symptoms of depression and/or anxiety change over time within a collaborative care model.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start22 Feb 2018
- Primary completion25 May 2018
- Study completion28 Aug 2018
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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliza M Park, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025190
- Sponsor's protocol ID
- LCCC 1704
- Status last verified
- Jul 2019
- First submitted
- 7 May 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population
- ClinicalTrials.gov ID
- NCT04025190
- Acronym / sponsor ID
- LCCC 1704
- Conditions
- Anxiety, Depression
- Keywords
- anxiety, depression, collaborative care, psycho-oncology, bone marrow transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 18 Jul 2019 (actual)
- 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 primary purpose of this study is twofold: (1) to assess the feasibility of screening adult hematopoietic stem cell transplantation (HSCT) candidates for psychiatric comorbidity (depression and anxiety), and (2) to assess the feasibility of treating depression and anxiety in adult HSCT candidates through a collaborative care algorithm. The ultimate goal of this project is improving HSCT outcomes for allogeneic HSCT candidates by improving identification and treatment of depression and anxiety disorders.
Detailed description
Enrollment and depression and anxiety symptom screening:
All patients who are candidates for allogeneic transplantation and have a scheduled "Pre-Admission Visit" at UNC will be screened by study team to assess if they are eligible for participation. At their "Pre-Admission Visit" patients will be approached for enrollment in the study. Patients who provide written informed consent will complete the Hospital Anxiety and Depression Scale (HADS) survey at that time. If patients screen positive on the HADS (meaning a score of 8 or greater in the anxiety or the depression sections), they will be offered treatment within a collaborative care model intervention. If patients score less than 8 on the HADS survey (negative for symptoms of anxiety or depression) at the Pre-Admission Visit, they will not be offered treatment on study. Their medical records will still be abstracted periodically to follow post-transplant outcomes.
The Collaborative Care Model:
The collaborative care model is a team-delivered treatment program and will be provided by a treatment team of HSCT advanced practice providers (APP), HSCT physician, Comprehensive Cancer Support Program (CCSP) clinicians, and a psychiatrist. The collaborative care treatment intervention will be offered if patients score positive (score of 8 or greater) on the HADS. The collaborative care intervention includes medication consideration, therapy evaluation, and referral to psychiatry if needed.
Treatment Options in the Collaborative Care Model:
There will be three treatment options in the collaborative care model that will be offered to patients who score 8 or greater on the HADS - pharmacologic therapy, non-pharmacologic therapy, or both. If a patient chooses to start pharmacologic therapy after discussion with the APP at the Pre-Admission Visit, this treatment will include one of two antidepressants, which are standard-of-care treatments in medicine. The nonpharmacologic treatment in the Collaborative Care Model will involve a therapy consultation by the CCSP once patient is admitted to the hospital for their HSCT. Patients can also opt to take part in therapy with CCSP as well as taking medications.
The study team at the time of enrollment will gather patient demographics and clinical information including gender, age, disease type, donor HLA match, and history of mental health disorders from the medical record.
Follow-up HADS Surveys:
On Day 0, (day of stem cell infusion) to the hospital for HSCT, patients will undergo another HADS survey, and this will be repeated at Day +14 (+/- 3 days), Day +30 (+/- 3 days), and Day +60 (+/- 3 days). Information will be gathered from the medical records on Day +14, Day +30, and Day +60 regarding symptoms of mucositis, inability to tolerate oral medications, development of hospital-acquired illnesses, ICU admissions, reactivation of viruses (i.e. CMV), readmission to hospital, engraftment status, development of GVHD, and missed clinic appointments.
During the course of the study, all cases will be reviewed weekly in meetings with the psychiatrist and HSCT APPs to address mood symptoms, evaluate the need for titration of medications, and evaluate the need for psychotherapy, provided by CCSP therapist or psychiatrist.
Satisfaction Surveys:
At six months from initial patient enrollment, satisfaction surveys will be distributed to the HSCT APPs and HSCT physicians who have taken part in the study. Each patient at the end of study will also complete a satisfaction survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Transplant | – | –All patients seen in the UNC Bone Marrow Transplant clinic who are candidates for allogeneic transplantation attending their pre-admission visit were approached to offer study participation. Study participation included completion of surveys over a time period up to 60 days after their transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients were English speaking adults (age >18 years) with hematological or non-hematological malignancy with an indication to undergo allogeneic HSCT, who were scheduled to undergo allogeneic transplant within 30 days of enrollment, had a scheduled Pre-Transplant Admission clinic visit at the ambulatory HSCT clinic, and were able to complete self-report measures. Patients were excluded if they were pregnant, unable to complete self-report measures in English, or had pre-existing diagnoses of bipolar affective disorder, schizoaffective disorder or schizophrenia.
Key inclusion criteria (5 listed)
- hematological or non-hematological malignancy
- plan to receive an allogeneic stem cell transplant
- patient at UNC's ambulatory BMT clinic
- able to complete self-report measures
- English speaking
Key exclusion criteria (5 listed)
- plan to receive an autologous transplant
- plan to receive allogeneic transplant for a non-malignancy
- unable to complete self report measures in English
- pregnant
- pre-existing diagnoses of bipolar affective disorder, schizoaffective disorder or schizophrenia
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
Systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale
Time frame: Day 0
Assess the feasibility of systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale in adult patients who are allogeneic HSCT candidates.
3 secondary outcomes
Satisfaction among patients and providers participating in the collaborative care model
Time frame: Day 0
Severity of post-transplant outcomes as defined by an investigator-designed post-transplant outcome index in relation to Hospital Anxiety and Depression Scale scores
Time frame: Day 0
Change in anxiety or depression as measured by the Hospital Anxiety and Depression Scale.
Time frame: Day 0
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 18 Jul 2019.
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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.
Eliza M Park, MD principal investigator
UNC Chapel Hill
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 Anxiety and Depression, run by UNC Lineberger Comprehensive Cancer Center 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 5 inclusion and 5 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 18 Jul 2019. 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?
Systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale (time frame: Day 0). 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 18 Jul 2019.