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Clinical Trials/NCT03626142
NCT03626142
Enrolling By Invitation
Not Applicable

Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

Stanford University1 site in 1 country200 target enrollmentJuly 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Stanford University
Enrollment
200
Locations
1
Primary Endpoint
Montgomery-Asberg Depression Rating Scale (MADRS)
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 9, 2018
End Date
December 1, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nolan R

Associate Professor, Psychiatrist, Neurologist

Stanford University

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Scale for Suicide Ideation (SSI)(Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention)
  • Young Mania Rating Scale (YMRS)(Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.)
  • Columbia-Suicide Severity Rating Scale (C-SSRS)(Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention)
  • Pittsburgh Insomnia Rating Scale (PIRS-20)(Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.)
  • Quick Inventory Depressive Symptomatology (QIDS)(Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.)
  • Number of hospital re-admissions and service use(Bi-weekly up until 24 weeks post-intervention)
  • Beck Depression Inventory II (BDI-II)(Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention)
  • Hamilton Rating Scale for Depression Six Item (HAMD-6)(Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.)
  • Immediate Mood Scaler (IMS-12)(weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.)

Study Sites (1)

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