DepressionNCT03011619
Brief CBT for the Treatment of Depression During Inpatient Hospitalization
A study testing Cognitive Behavioral Therapy Condition (CBT) in people with Depression, run by NYU Langone Health at 1 site in United States.
Trial summary
Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavioral Therapy Condition (CBT)
- 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
- 6 Apr 2017to 5 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.
- Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and CGI-S.
- Provides written informed consent.
Who cannot join
- A mental illness other than depression that is the primary cause of treatment, as determined by the Principal Investigator.
- A cognitive or neurologic disorder that inhibits ability to engage in CBT.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT).
Read the detailed description
Participants assigned to the CBT condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy. If a patient is randomly assigned to the enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.The training M.D., who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT sessions to ensure the manual properly is being followed. Although the control condition may contain elements of CBT as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the CBT condition. Participants assigned to the control condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy.
- Conditions
- Depression
- Being tested
- Usual Standard of Care, Cognitive Behavioral Therapy Condition (CBT)
- Keywords
- Depression, Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Standard of CareBehavioural
medication management, group therapy, and individual therapy.
Cognitive Behavioral Therapy Condition (CBT)Behavioural
CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | Active comparator | usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy. Receives: Behavioral: Usual Standard of Care |
| CBT Condition | Experimental | If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries. Receives: Behavioral: Usual Standard of Care; Behavioral: Cognitive Behavioral Therapy Condition (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Ashberg Depression Scale (MADRS)
A ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. The ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe). It is designed to be sensitive to change, so is often the scale of choice when interventions, such as psychotherapies, electroconvulsive therapy, or drug trials, are being studied.
Measured: 15 Minutes
Hamilton Rating Scale for Depression (HAM-D)
Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness.
Measured: 20 Minutes
Clinical Global Impression Severity Scale (CGI-S)
Single-item rating scale of the clinician's assessment of the global severity of depressive symptoms in relation to the clinician's total experience with depressed patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start6 Apr 2017
- Primary completion5 Apr 2018
- Study completion5 Apr 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 DepressionStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Sergie, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011619
- Sponsor's protocol ID
- 16-01404
- Status last verified
- Mar 2019
- First submitted
- 4 Jan 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief CBT for the Treatment of Depression During Inpatient Hospitalization
- ClinicalTrials.gov ID
- NCT03011619
- Acronym / sponsor ID
- 16-01404
- Conditions
- Depression
- Keywords
- Depression, Cognitive Behavioral Therapy (CBT)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 5 Jan 2017 (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.
Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT).
Detailed description
Participants assigned to the CBT condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy. If a patient is randomly assigned to the enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.The training M.D., who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT sessions to ensure the manual properly is being followed. Although the control condition may contain elements of CBT as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the CBT condition. Participants assigned to the control condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Active comparator | Behavioral: Usual Standard of Careusual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy. |
| CBT Condition | Experimental | Behavioral: Usual Standard of Care, Behavioral: Cognitive Behavioral Therapy Condition (CBT)If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.
- Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and CGI-S.
- Provides written informed consent.
Key exclusion criteria (2 listed)
- A mental illness other than depression that is the primary cause of treatment, as determined by the Principal Investigator.
- A cognitive or neurologic disorder that inhibits ability to engage in CBT.
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 |
|---|---|---|
| Usual Standard of Caremedication management, group therapy, and individual therapy. | Behavioural | CBT Condition, Control Condition |
| Cognitive Behavioral Therapy Condition (CBT)CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries. | Behavioural | CBT Condition |
Primary outcome
Montgomery-Ashberg Depression Scale (MADRS)
Time frame: 15 Minutes
A ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. The ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe). It is designed to be sensitive to change, so is often the scale of choice when interventions, such as psychotherapies, electroconvulsive therapy, or drug trials, are being studied.
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 20 Minutes
Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness.
Clinical Global Impression Severity Scale (CGI-S)
Time frame: 20 Minutes
Single-item rating scale of the clinician's assessment of the global severity of depressive symptoms in relation to the clinician's total experience with depressed patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
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 26 Mar 2019.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Jacqueline Sergie, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy Condition (CBT) in people with Depression, 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 3 inclusion and 2 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 26 Mar 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 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?
Montgomery-Ashberg Depression Scale (MADRS) (time frame: 15 Minutes). The study lists 3 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 26 Mar 2019.