Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit



Sponsors

Lead Sponsor



Source

Stanford University

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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,
at 6 and 8 weeks after the intervention and then monthly until 6 months post-intervention in
order to monitor their symptoms. Participants will have consented to be contacted at these
regular intervals before being discharged from the inpatient unit. During the weekly and
fortnightly follow-up sessions, 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) Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q- SF)
Questionnaires regarding the symptoms associated with the participant's preliminary
psychiatric diagnosis (if not MDD) will also be administered.

The monthly follow-ups (3-6 months after discharge) will involve the following assessments:

HAMD-6 QIDS Immediate Mood Scaler (IMS-12) Quality of Life Enjoyment and Satisfaction
Questionnaire - Short Form (Q-LES-Q- SF) Questionnaires regarding the symptoms associated
with the participant's preliminary psychiatric diagnosis (if not MDD) 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)

Overall Status

Recruiting

Start Date

2018-07-09

Completion Date

2020-12-01

Primary Completion Date

2020-12-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

The duration of anti-depressant response (in weeks) according to the Hamilton Rating Scale for Depression Six Item (HAMD-6)
Participants symptoms will be monitored up until 6 months after aiTBS or until their symptoms return to baseline.

Secondary Outcome

Measure

Time Frame

Scale for Suicide Ideation (SSI)
2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks & 24 weeks post-intervention
Montgomery-Asberg Depression Rating Scale (MADRS)
2 weeks, 4 weeks, 6 weeks, 8 weeks post-intervention
Young Mania Rating Scale (YMRS)
2 weeks, 4 weeks, 6 weeks, 8 weeks post-intervention
Quick Inventory Depressive Symptomatology (QIDS)
2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks & 24 weeks post-intervention
Pittsburgh Insomnia Rating Scale (PIRS-20)
2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks & 24 weeks post-intervention
Number of hospital re-admissions and service use
2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks & 24 weeks post-intervention
Quality of Life Enjoyment and Satisfaction Questionnaire-short form (Qlesqsf)
2 weeks, 4 weeks, 6 weeks, 8 weeks post-intervention

Number Of Groups

4

Enrollment

200

Conditions


Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Eleanor Cole, PhD

Phone

4157247960

Email



Location

Facility

Status

Contact

Stanford Hospital
Palo Alto California 94305 United States
Recruiting
Last Name: Eleanor Cole, PhD
Phone: 415-724-7960
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Stanford University

Investigator Full Name

Nolan Williams

Investigator Title

Associate Professor, Psychiatrist, Neurologist


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Left DLPFC aTBS stimulation

Description

Patients who have received accelerated theta burst stimulation delivered to the left dorsolateral prefrontal cortex on the inpatient unit at Stanford


Arm Group Label

ACC aTBS stimulation

Description

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


Arm Group Label

Ketamine

Description

Patients who have received ketamine on the inpatient unit at Stanford


Arm Group Label

ECT

Description

Patients who have received ECT on the inpatient unit at Stanford



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Nolan Williams, MD

Phone

8434607741

Email



Reference

Citation

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.

PMID

27899052


Citation

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.

PMID

26528644


Citation

Berggren Å, Gustafson L, Höglund 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.

PMID

24997226


Citation

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.

PMID

22840761


Citation

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.

PMID

20966770



Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Only

Time Perspective

Cross-Sectional


Study First Submitted

July 6, 2018

Study First Submitted Qc

August 7, 2018

Study First Posted

August 10, 2018

Last Update Submitted

August 7, 2018

Last Update Submitted Qc

August 7, 2018

Last Update Posted

August 10, 2018


ClinicalTrials.gov processed this data on August 10, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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