Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

Conditions
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Depressive Symptoms, Suicidal Ideation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left DLPFC aTBS stimulation<br>Patients who have received accelerated theta burst stimulation delivered to the left dorsolateral prefrontal cortex on the inpatient unit at Stanford | |
| ACC aTBS stimulation<br>Patients who have received accelerated theta burst stimulation delivered to the anterior cingulate cortex on the inpatient unit at Stanford | |
| ECT<br>Patients who have received ECT on the inpatient unit at Stanford | |

What is the study measuring?
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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 |