- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599247
Natural History of Hopelessness, Suicidality, and Optimism in Psychiatric Inpatients Following Discharge
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
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Suicidal Ideation
-
Northwestern UniversityNot yet recruitingSuicidal Ideation and Behavior
-
University GhentRecruitingSuicide | Suicidal Ideation and Behavior | Crisis InterventionBelgium
-
Shira BarzilaySchneider Children's Medical Center, IsraelRecruiting
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation and BehaviorUnited States
-
Bradley HospitalNational Institute of Mental Health (NIMH); Instituto Nacional de Psiquiatría...Not yet recruitingSuicidal Ideation/BehaviorMexico
-
Oriana Arellano FaúndezActive, not recruitingSuicidal Ideation | Suicidal Ideation and BehaviorsChile