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Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626142
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nolan R, Stanford University

Brief Summary:
This study will monitor the symptoms of patients who have received an intervention on the psychiatric inpatient unit at Stanford hospital up to 6 months after they have received the intervention. Additionally, the acceptability and feasibility of interventions will be assessed using clinician and patient questionnaires.

Condition or disease
Depressive Symptoms Suicidal Ideation

Detailed Description:

Once patients have been discharged from hospital they will be contacted weekly for 4 weeks and then every 2 weeks until 6 months post-intervention in order to monitor their symptoms. Participants will be followed up until the end of the study (6 months after the intervention) or until they no longer meet responder criteria (MADRS score>50% of score before they received the intervention) During the follow-ups for the first 8 weeks, the following assessments will be conducted: Montgomery-Åsberg Depression Rating Scale (MADRS) Scale of suicidal ideation (SSI) Hamilton depression rating scale (HAMD-6) Young Mania Rating Scale (YMRS) Pittsburgh insomnia rating scale (PIRS-20) Quick inventory of depressive symptomatology (QIDS) Immediate Mood Scaler (IMS-12) Beck Depression Inventory (BDI-II) C-SSRS self-report short version

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) will be collected at one month post-intervention.

If the participant has a psychiatric diagnosis(/es) other than MDD, questionnaires measuring the symptoms associated with the participant's other psychiatric diagnosis/(es) will also be administered.

Follow-up assessments from 10-24 weeks will include:

MADRS SSI BDI-II C-SSRS self-report short version

If the participant has a psychiatric diagnosis other than MDD, questionnaires measuring the symptoms associated with the participant's other psychiatric diagnosis/(es) will also be administered.

The questionnaires that will be used to assess symptoms associated with primary psychiatric diagnoses are:

  • Bipolar disorder: YMRS
  • Schizoaffective disorder/ Schizophrenia/Schizophreniform disorder: positive and negative symptom scale (PANSS) and the Calgary Depression Scale for Schizophrenia (CDSS)
  • Alcohol use disorder: Alcohol craving questionnaire self-report (ACQ-SR) and obsessive compulsive drinking scale (OCDS)
  • Drug use disorders: Modified versions of the alcohol scales to make these relevant to the particular drug of abuse.
  • Anorexia Nervosa: Yale-Brown-Cornell Eating Disorder Scale [YBC-EDS], Eating disorder examination questionnaire (EDE-Q)
  • Bulimia Nervosa: Yale-Brown-Cornell Eating Disorder Scale [YBC-EDS], Eating disorder examination questionnaire (EDE-Q)
  • Binge eating disorder: Young-Brown Obsessive Compulsive Scale Modified for Binge Eating [YBOCS-BE]
  • OCD: Obsessive compulsive inventory (OCI) and Yale-Brown Obsessive Compulsive Scale (YBOCS)
  • PTSD: Post-traumatic Stress Disorder Checklist-Civilian Version [PCL-C]
  • Generalized anxiety disorder: Generalized Anxiety Disorder 7-item (GAD-7) scale
  • Chronic pain: Numeric Rating Scale (NRS) for Chronic Pain
  • Panic Disorder: Panic Disorder Severity Scale (PDSS)
  • Somatoform Disorders: The Somatic Symptom Scale (SSS-8)
  • Impulse Control disorders: Massachusetts General Hospital Hairpulling Scale (This questionnaire will be adapted depending on the urges the patient cannot control e.g. compulsive picking) BPD: The Borderline Evaluation of Severity Over Time (BEST)

At all time points, information regarding medication changes and other psychiatric treatments will be collected.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Group/Cohort
Left DLPFC aTBS stimulation
Patients who have received accelerated theta burst stimulation delivered to the left dorsolateral prefrontal cortex on the inpatient unit at Stanford
ACC aTBS stimulation
Patients who have received accelerated theta burst stimulation delivered to the anterior cingulate cortex on the inpatient unit at Stanford
ECT
Patients who have received ECT on the inpatient unit at Stanford



Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention ]
    This is a ten-item clinician rated questionnaire in which the clinician rates each item from 0-6. Scores of 6 indicate more severe depressive symptoms. Total scores are between 0 and 60 with scores >35 indicating severe depression. Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10.


Secondary Outcome Measures :
  1. Scale for Suicide Ideation (SSI) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention ]
    Clinical assessment measuring suicidal thoughts & behaviors

  2. Beck Depression Inventory II (BDI-II) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention ]

    The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.

    Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression


  3. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention ]

    Self-report questionnaire identifying the presence or absence of six suicidal thoughts or behaviors in the past month or since the last visit. Each 'yes' answer is scored as 1, meaning the maximum total score is 6.

    The scale identifies specific behaviors which may be indicative of a person's intent to complete suicide. An person exhibiting even a single behavior identified by the scale was 8 to 10 times more likely to complete suicide.


  4. Young Mania Rating Scale (YMRS) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention. ]
    11-item multiple choice clinician-rated questionnaire. Each question is rated from 0 to 4 with 4

  5. Pittsburgh Insomnia Rating Scale (PIRS-20) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention. ]
    Self-report insomnia rating scale

  6. Hamilton Rating Scale for Depression Six Item (HAMD-6) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention. ]
    Response is defined as a 50% reduction or greater in HAMD-6 score compared to baseline. HAMD-6 is a 6-item clinical assessment measuring depressive symptoms (scores range from 0-24 with scores of 5 or more indicating clinical levels of depression). The number of weeks in which HAMD-6 scores are lower than 50% of baseline will be calculated to provide a measure of duration of response.

  7. Quick Inventory Depressive Symptomatology (QIDS) [ Time Frame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention. ]
    Self-report measure of depressive symptoms

  8. Immediate Mood Scaler (IMS-12) [ Time Frame: weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention. ]
    12-item self-report questionnaire used to measure current mood

  9. Number of hospital re-admissions and service use [ Time Frame: Bi-weekly up until 24 weeks post-intervention ]
    The number of times patients are re-admitted to hospital and used psychiatric services since the last assessment will be recorded



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the psychiatric unit at Stanford University displaying depressive symptoms or suicidal ideation
Criteria

Inclusion Criteria:

  • Received an intervention on the psychiatric inpatient unit at Stanford Hospital aimed at treating a major depressive episode or suicidal ideation

Exclusion Criteria:

-None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626142


Contacts
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Contact: Eleanor Cole, PhD 4157247960 ecole@stanford.edu
Contact: Romina Nejad, MSc 9493169363 rnejad@stanford.edu

Locations
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United States, California
Stanford Hospital Recruiting
Palo Alto, California, United States, 94305
Contact: Eleanor Cole, PhD    415-724-7960    ecole@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Nolan Williams, MD Stanford University
Publications:
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Responsible Party: Nolan R, Associate Professor, Psychiatrist, Neurologist, Stanford University
ClinicalTrials.gov Identifier: NCT03626142    
Other Study ID Numbers: 45301
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Suicidal Ideation
Behavioral Symptoms
Suicide
Self-Injurious Behavior