Clinical trial NCT03626142: Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit
Official title: Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Depressive Symptoms
Suicidal Ideation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the psychiatric unit at Stanford University displaying depressive symptoms or suicidal ideation

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.

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:

-None

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
Secondary outcomes:
measure: Scale for Suicide Ideation (SSI)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention
measure: Young Mania Rating Scale (YMRS)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
measure: Pittsburgh Insomnia Rating Scale (PIRS-20)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
measure: Hamilton Rating Scale for Depression Six Item (HAMD-6)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
measure: Quick Inventory Depressive Symptomatology (QIDS)
timeFrame: Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
measure: Immediate Mood Scaler (IMS-12)
timeFrame: weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.
measure: Number of hospital re-admissions and service use
timeFrame: Bi-weekly up until 24 weeks post-intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Nolan Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
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