Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicidal Ideation; Depressive Symptoms

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the psychiatric unit at Stanford University displaying depressive symptoms or suicidal ideation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	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.	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale for Suicide Ideation (SSI)	Clinical assessment measuring suicidal thoughts & behaviors	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Beck Depression Inventory II (BDI-II)	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	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)	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.	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Young Mania Rating Scale (YMRS)	11-item multiple choice clinician-rated questionnaire. Each question is rated from 0 to 4 with 4	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Pittsburgh Insomnia Rating Scale (PIRS-20)	Self-report insomnia rating scale	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Hamilton Rating Scale for Depression Six Item (HAMD-6)	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.	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Quick Inventory Depressive Symptomatology (QIDS)	Self-report measure of depressive symptoms	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Immediate Mood Scaler (IMS-12)	12-item self-report questionnaire used to measure current mood	weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
Number of hospital re-admissions and service use	The number of times patients are re-admitted to hospital and used psychiatric services since the last assessment will be recorded	Bi-weekly up until 24 weeks post-intervention

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Kelly MS, Oliveira-Maia AJ, Bernstein M, Stern AP, Press DZ, Pascual-Leone A, Boes AD. Initial Response to Transcranial Magnetic Stimulation Treatment for Depression Predicts Subsequent Response. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):179-182. doi: 10.1176/appi.neuropsych.16100181. Epub 2016 Nov 30.
• Haq AU, Sitzmann AF, Goldman ML, Maixner DF, Mickey BJ. Response of depression to electroconvulsive therapy: a meta-analysis of clinical predictors. J Clin Psychiatry. 2015 Oct;76(10):1374-84. doi: 10.4088/JCP.14r09528.
• Berggren A, Gustafson L, Hoglund P, Johanson A. A long-term follow-up of clinical response and regional cerebral blood flow changes in depressed patients treated with ECT. J Affect Disord. 2014;167:235-43. doi: 10.1016/j.jad.2014.06.005. Epub 2014 Jun 12.
• Murrough JW, Perez AM, Pillemer S, Stern J, Parides MK, aan het Rot M, Collins KA, Mathew SJ, Charney DS, Iosifescu DV. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry. 2013 Aug 15;74(4):250-6. doi: 10.1016/j.biopsych.2012.06.022. Epub 2012 Jul 27.
• Dell'osso B, D'Urso N, Castellano F, Ciabatti M, Altamura AC. Long-term efficacy after acute augmentative repetitive transcranial magnetic stimulation in bipolar depression: a 1-year follow-up study. J ECT. 2011 Jun;27(2):141-4. doi: 10.1097/YCT.0b013e3181f66601.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2018
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Depression; Suicidal Ideation
• Other Study ID Numbers: 45301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No