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.
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
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:
- 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.
- 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:
- 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.
- 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.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- 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 group | Role | What they receive |
|---|---|---|
| Suicidal ideation/behavior | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted15 May 2012 (estimated)
- Study startJul 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Hopelessness, Suicidality, and Optimism in Psychiatric Inpatients Following Discharge
- ClinicalTrials.gov ID
- NCT01599247
- Acronym / sponsor ID
- 2010P002851
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Keywords
- Suicide, Optimism, Hopelessness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jul 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suicidal ideation/behavior | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Inpatient Psychiatric Unit at Massachusetts General Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change in the natural history of hopelessness, suicidal thoughts, and optimism
Time frame: 2, 4, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff C Huffman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
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.