Natural History of Hopelessness, Suicidality, and Optimism in Psychiatric Inpatients Following Discharge

Suicidal Ideation Clinical Trial

Official title:

Natural History of Hopelessness, Suicidality, and Optimism in Psychiatric Inpatients Following Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599247
• Other study ID #: 2010P002851
• Status: Completed
• Phase: N/A
• First received: May 2, 2012
• Last updated: August 7, 2014
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Specific aim #1: To assess the study team's ability to recruit subjects in this cohort and to successfully complete follow-up assessments by phone or mail.

Hypothesis: Over 50% of eligible subjects will enroll in the observational study, and 70% of follow-up assessments will be successfully completed.

Specific aim #2: To determine the natural history of hopelessness, ongoing suicidal thoughts, and optimism in subjects at 2, 4 and 8 weeks after discharge.

Hypothesis: Subjects will continue to have moderate levels of hopelessness, suicidal thoughts, and optimism at follow-up assessments.

Description:

Contact information. On the day of enrollment, contact information (address, phone number) will be obtained from the subject. Subjects will also be asked to provide the contact information for a family member or friend who the study team may contact in case of emergency or if unable to get in touch with subject at follow up. Subjects unable to provide contact information for at least one family member will not be enrolled.

Baseline evaluation.

On the date of enrollment, study staff will obtain two types of information:

1. Baseline clinical characteristics. Study staff will obtain specific clinical variables from the patient to gather information about variables that could impact levels of hopelessness/optimism after discharge. These variables include: age, gender, # of prior admissions [zero, 1-5, more than 5], presence of substance use disorder (assessed via inpatient chart review), admission for suicide attempt or suicidal ideation only, and involvement in exercises that can increase feelings of well-being like gratitude, forgiveness, using one's personal strengths, and acts of kindness.

2. Baseline outcome measures: Study staff will also administer six instruments:

• Beck Hopelessness Scale (BHS):14 This is a 21-item scale used to assess feelings of hopelessness.

• Concise Health Risk Tracking Scale (CHRT):15 This is a 12 item scale used to assess the presence and intensity of suicidal thoughts.

• Life Orientation Test-Revised (LOT-R):16 This is a 10-item scale that measures optimism (and pessimism).

• Positive Affect Negative Affect Schedule (PANAS):17 This is a well-validated 20-item self-report measure of more general positive and negative affect.

• Sheehan Disability Scale:18 This is a 5 item scale used to assess the degree to which the subject's condition or disease (psychological, social, physical) has impacted his or her functioning in daily life.

• Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR):19 This is a 16-item questionnaire that assesses the subject's depressive symptoms. It will serve as an additional reliable, valid way to gather information on the subject's mood.

This evaluation should take approximately 20-30 minutes.

Follow-up assessments.

Follow-up assessments will occur by phone or mail at 2 weeks, 4 weeks and 8 weeks. Similar to initial assessments, the follow-up assessments will have two components:

1. Assessment of characteristics: Study staff will inquire about subjects' living situation at discharge (homelessness, living alone), employment/academic status, treatment postdischarge (follow-up with therapist, psychiatrist, PCP, groups, AA/NA, partial hospital programs, and other treatment and forms of peer support), and involvement in exercises that can increase feelings of well-being like gratitude, forgiveness, using one's personal strengths, and acts of kindness.

2. Assessment of study outcomes: Staff will readminister the five measures above, and will also inquire about psychiatric readmissions, suicide attempts, and episodes of self-harm (cutting, burning, banging/hitting body parts, ingesting toxic materials/objects, and other intentional non-suicidal self-harm behaviors). This evaluation should take 20-30 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Admission to MGH inpatient psychiatric unit, age 18 and older

• Suicidal ideation reported on admission (suicidal thoughts or active suicidal ideation documented in the admission note) OR admission occurring in context of a suicide attempt

• Mood disorder (assessed and determined by patient's clinical treatment team and consulting inpatient chart review)

• Patient able to read and write in English

Exclusion criteria:

• Psychotic symptoms, as assessed using the MINI12 and inpatient chart review

• Cognitive disorder, as assessed using a six-item cognitive screen developed for research

• Participation in other studies that are focused on improving hopelessness/optimism.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide, Attempted

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to recruit and retain subjects in this cohort	Number of subjects who enroll in the study, and number of subjects who complete phone or written follow-ups at each time point.	2 years	No
Secondary	Change in the natural history of hopelessness, suicidal thoughts, and optimism	Changes in scores between baseline and 2/4/8 weeks after discharge. Rates of readmission to hospital, suicidal thoughts, and non-suicidal self-harming behaviors	2, 4, and 8 weeks	No