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

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ClinicalTrials.gov Identifier: NCT01599247
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : August 8, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital

Brief 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.


Condition or disease
Suicide, Attempted Suicidal Ideation

Detailed 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.

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Hopelessness, Suicidality, and Optimism in Psychiatric Inpatients Following Discharge
Study Start Date : July 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Group/Cohort
Suicidal ideation/behavior



Primary Outcome Measures :
  1. Ability to recruit and retain subjects in this cohort [ Time Frame: 2 years ]
    Number of subjects who enroll in the study, and number of subjects who complete phone or written follow-ups at each time point.


Secondary Outcome Measures :
  1. Change in the natural history of hopelessness, suicidal thoughts, and optimism [ Time Frame: 2, 4, and 8 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Inpatient Psychiatric Unit at Massachusetts General Hospital
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599247


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital

Responsible Party: Jeff C. Huffman, MD, Medical Director, Blake 11, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01599247     History of Changes
Other Study ID Numbers: 2010P002851
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Jeff C. Huffman, MD, Massachusetts General Hospital:
Suicide
Optimism
Hopelessness

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms