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

August 7, 2014 updated by: Jeff C. Huffman, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

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

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Inpatient Psychiatric Unit at Massachusetts General Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Suicidal ideation/behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2, 4, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (ESTIMATE)

May 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2010P002851

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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