Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

NCT ID: NCT03626142

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-09

Study Completion Date

2025-12-01

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.

Conditions

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Depressive Symptoms Suicidal Ideation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

ACC aTBS stimulation

Patients who have received accelerated theta burst stimulation delivered to the anterior cingulate cortex on the inpatient unit at Stanford

No interventions assigned to this group

ECT

Patients who have received ECT on the inpatient unit at Stanford

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Nolan R

Associate Professor, Psychiatrist, Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nolan Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Hospital

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27899052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26528644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24997226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22840761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20966770 (View on PubMed)

Other Identifiers

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45301

Identifier Type: -

Identifier Source: org_study_id

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