Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

• Conditions: Suicidal Ideation; Depressive Symptoms

• Registration Number: NCT03626142
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2018-07-06
• Study Start: 2018-07-09
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-06
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

-None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	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 Outcome Measures

Name	Time	Method
Scale for Suicide Ideation (SSI)	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention	Clinical assessment measuring suicidal thoughts \& behaviors
Young Mania Rating Scale (YMRS)	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.	11-item multiple choice clinician-rated questionnaire. Each question is rated from 0 to 4 with 4
Columbia-Suicide Severity Rating Scale (C-SSRS)	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention	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.
Pittsburgh Insomnia Rating Scale (PIRS-20)	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.	Self-report insomnia rating scale
Quick Inventory Depressive Symptomatology (QIDS)	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.	Self-report measure of depressive symptoms
Number of hospital re-admissions and service use	Bi-weekly up until 24 weeks post-intervention	The number of times patients are re-admitted to hospital and used psychiatric services since the last assessment will be recorded
Beck Depression Inventory II (BDI-II)	Weekly for first 4 weeks, followed by bi-weekly up until 24 weeks post-intervention	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
Hamilton Rating Scale for Depression Six Item (HAMD-6)	Weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.	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.
Immediate Mood Scaler (IMS-12)	weekly for first 4 weeks, followed by bi-weekly up until 8 weeks post-intervention.	12-item self-report questionnaire used to measure current mood

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Palo Alto, California, United States