Suicidal IdeationHOPENCT01398891
Development of a Positive Psychology Intervention to Reduce Suicide Risk
A study testing Positive Psychology Exercises in people with Suicidal Ideation and Suicide Attempt, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase enrollment rates and obtain information for patients with a wide range of diagnoses and illness severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide Attempt
- What is being tested?
- Positive Psychology Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 2013
- Phase
- Interventional
- 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
Who may be able to join
- Adult (age 18 and older) admitted to inpatient psychiatric unit at Massachusetts General Hospital
- Suicidal ideation at time of admission OR
- Admission occurring in context of suicide attempt
- Ability to read and write in English
Who cannot join
- Psychotic symptoms
- Cognitive disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase enrollment rates and obtain information for patients with a wide range of diagnoses and illness severity. Enrolled subjects will complete randomly-selected positive psychology exercises daily (on weekdays) until discharge and will rate the exercises in multiple domains. Subjects' participation will be complete at the end of their admission or when all exercises have been completed, whichever comes first.
Overall, our goal is to assess the acceptability and utility of eight possible positive psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection, and forgiveness in suicidal inpatients.
This is a single-arm study, completed with patients who have been admitted to the hospital for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology treatment aimed at suicidal patients. The study consists of serial completion of different positive psychology exercises, once daily, during admission, to get subjects' input on their feasibility and impact. This will allow us to work collaboratively to identify the specific exercises that best fit this population. Subjects' participation ends when they are discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total) in this study.
- Conditions
- Suicidal Ideation, Suicide Attempt
- Being tested
- Positive Psychology Exercises
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology ExercisesOther
At each session, the interventionalist will prepare the subject to complete a randomly-selected positive psychology exercise, lasting approximately 20 minutes, within the next 24 hours. He or she will describe the rationale for the exercise and the details of the exercise, and will answer any questions. A sheet with written instructions (matching the verbal instructions) for the exercise will be provided, with space for recording the exercise and an area to provide ratings on the exercise. On the following day, the interventionalist will review the prior day's exercise (and record whether it was completed). The exercises will be completed daily on weekdays for a maximum of 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology Exercises | Experimental | Not described Receives: Other: Positive Psychology Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of exercises
Exercises assigned each day and assessed for completion the next day (a total of eight exercises)
Measured: Every 24 hours until all exercises administered or discharge occurs
Secondary outcomes (3)
Optimism
Life Orientation Test-Revised
Measured: Baseline and on the date of discharge (average length of admission= 2 weeks)
Feasibility and utility of exercises
Self-report using Likert scale
Measured: Assessed within 24 hours of exercise completion
Hopelessness
Beck Hopelessness Scale
Measured: Baseline and on the date of discharge (average length of admission=2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT01398891
- Sponsor's protocol ID
- 2010P002826
- Acronym
- HOPE
- Status last verified
- Mar 2013
- First submitted
- 15 Jul 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Positive Psychology Intervention to Reduce Suicide Risk
- ClinicalTrials.gov ID
- NCT01398891
- Acronym / sponsor ID
- HOPE / 2010P002826
- Conditions
- Suicidal Ideation, Suicide Attempt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Jul 2011 (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.
This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase enrollment rates and obtain information for patients with a wide range of diagnoses and illness severity. Enrolled subjects will complete randomly-selected positive psychology exercises daily (on weekdays) until discharge and will rate the exercises in multiple domains. Subjects' participation will be complete at the end of their admission or when all exercises have been completed, whichever comes first.
Overall, our goal is to assess the acceptability and utility of eight possible positive psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection, and forgiveness in suicidal inpatients.
This is a single-arm study, completed with patients who have been admitted to the hospital for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology treatment aimed at suicidal patients. The study consists of serial completion of different positive psychology exercises, once daily, during admission, to get subjects' input on their feasibility and impact. This will allow us to work collaboratively to identify the specific exercises that best fit this population. Subjects' participation ends when they are discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total) in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology Exercises | Experimental | Other: Positive Psychology Exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (age 18 and older) admitted to inpatient psychiatric unit at Massachusetts General Hospital
- Suicidal ideation at time of admission OR
- Admission occurring in context of suicide attempt
- Ability to read and write in English
Key exclusion criteria (2 listed)
- Psychotic symptoms
- Cognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Psychology ExercisesAt each session, the interventionalist will prepare the subject to complete a randomly-selected positive psychology exercise, lasting approximately 20 minutes, within the next 24 hours. He or she will describe the rationale for the exercise and the details of the exercise, and will answer any questions. A sheet with written instructions (matching the verbal instructions) for the exercise will be provided, with space for recording the exercise and an area to provide ratings on the exercise. On the following day, the interventionalist will review the prior day's exercise (and record whether it was completed). The exercises will be completed daily on weekdays for a maximum of 8 days. | Other | Positive Psychology Exercises |
Primary outcome
Completion of exercises
Time frame: Every 24 hours until all exercises administered or discharge occurs
Exercises assigned each day and assessed for completion the next day (a total of eight exercises)
3 secondary outcomes
Optimism
Time frame: Baseline and on the date of discharge (average length of admission= 2 weeks)
Feasibility and utility of exercises
Time frame: Assessed within 24 hours of exercise completion
Hopelessness
Time frame: Baseline and on the date of discharge (average length of admission=2 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 5 Mar 2013.
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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?
A study testing Positive Psychology Exercises in people with Suicidal Ideation and Suicide Attempt, 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 2 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 5 Mar 2013. 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?
Completion of exercises (time frame: Every 24 hours until all exercises administered or discharge occurs). 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 5 Mar 2013.