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Suicide, AttemptedNCT01599247

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

An observational study of Suicide, Attempted and Suicidal Ideation, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide, Attempted, Suicidal Ideation
How many people
46 participants
Where
1 siteUnited States
Study dates
Jul 2011to Jan 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to the Inpatient Psychiatric Unit at Massachusetts General Hospital

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.
Keywords
Suicide, Optimism, Hopelessness
Medical subject headings
Suicide, Attempted, Suicidal Ideation, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01599247
Study groupRoleWhat they receive
Suicidal ideation/behaviorNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (1)
  1. 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

    Measured: 2, 4, and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2012 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01599247
Sponsor's protocol ID
2010P002851
Status last verified
Aug 2014
First submitted
2 May 2012
Last updated
8 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Suicide, Attempted and Suicidal Ideation, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability to recruit and retain subjects in this cohort (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.

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