Suicidal ThoughtsPOPSNCT02855736
Positive Psychology in Suicidal Patients
A study testing Positive Psychology in people with Suicidal Thoughts and Suicidal Crisis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide risk period for those having current suicidal ideation or attempt. Recently, a pilot study suggested the feasibility of positive psychology in patients in suicidal crisis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Thoughts, Suicidal Crisis
- What is being tested?
- Positive Psychology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jul 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being hospitalized for suicidal thoughts or suicide attempt (from less than a week)
- Having signed informed consent
- Be fluent in French
- Able to understand nature, aims and methodology of the study
Who cannot join
- Lifetime history of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria
- Current eating disorder according to DSM-V criteria
- Patient on protective measures (guardianship or trusteeship)
- Deprived of liberty subject (judicial or administrative decision)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Study site
Montpellier, Hérault
Catherine Genty, MD, +33 4 67 61 45 75, c-genty@chu-montpellier.fr
About this study
Official title: Effectiveness of Positive Psychology in Suicidal Patients: A Randomized Controlled Trial
Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide risk period for those having current suicidal ideation or attempt. Recently, a pilot study suggested the feasibility of positive psychology in patients in suicidal crisis. Notably, gratitude exercises suggested improvement in optimism and hopelessness, two dimensions associated to suicide. Moreover, gratitude has been associated to suicidal ideation and attempt, independently from depression. Thus, investigators want to conduct the first randomized controlled study in order to assess effectiveness of gratitude exercises (vs control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.
Read the detailed description
Study design: monocentric randomized controlled study
Methods:
206 inpatients (Department of Emergency Psychiatry and Post Acute Care), between 18 and 65 years-old, having attempted suicide before hospitalisation or having current active suicidal ideation at the time of the psychiatric hospitalisation. Patients suffering from schizophrenia are excluded.
Randomization into two groups: Positive Psychology (i.e., gratitude journal) (n = 103) or Control Task (i.e., food journal) (n = 103), daily exercises during 7 days (in add-on from usual treatment).
Clinical assessment: 1) at baseline (the day before the intervention beginning) (V0); 2) short daily self-assessments (immediately before and after the exercise); 3) the day following the last day of the intervention (V1).
- V0 : socio-demographic data, treatments, psychopathology, suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness.
- Daily self-assessments: psychological pain, optimism, hopelessness
- V1 : treatments suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness, intervention satisfaction.
- Conditions
- Suicidal Thoughts, Suicidal Crisis
- Being tested
- Positive Psychology, Placebo (food journal)
- Keywords
- Suicidal inpatients, Positive Psychology, Gratitude, Psychological pain
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychologyBehavioural
Gratitude Journal (Emmons and Stern, 2013)
Every evening, patients have to write down the things they feel grateful about.
Placebo (food journal)Behavioural
Food journal (i.e. alimentary list):
Patients have to write down the list of foods eaten during the day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Positive Psychology (gratitude journal) Receives: Behavioral: Positive Psychology |
| Control group | Placebo comparator | Alimentary list Receives: Behavioral: Placebo (food journal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological pain reduction using a likert scale
Psychological pain reduction, in gratitude vs control group, between the beginning and the end of the intervention, using a likert scale.
Measured: At the inclusion and day 8 (the day after the end of the intervention)
Secondary outcomes (10)
Psychological pain reduction using a likert scale
Psychological pain reduction, in gratitude vs control group, the beginning and the end of each exercise, using a likert scale.
Measured: At day 1, 2, 3, 4, 5, 6, 7
intensity of suicidal ideation
Reduction of suicidal ideation intensity, in gratitude vs control group between the beginning and the end of the intervention using a Likert Scale and the Scale for Suicidal Ideation (SSI).
Measured: At the inclusion and day 8 (the day after the end of the intervention)
Intensity of hopelessness
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of the intervention, using a Likert Scale and the Beck Hopelessness Scale (BHS).
Measured: At the inclusion and day 8 (the day after the end of the intervention)
Intensity of optimism
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of the intervention, using a Likert Scale and the Life Orientation Test-Revised (LOT-R).
Measured: At the inclusion and day 8 (the day after the end of the intervention)
Intensity of depressive symptoms using the Beck Depression Inventory (BDI)
Reduction of depressive symptoms between the beginning and the end of the intervention, using the Beck Depression Inventory (BDI)
Measured: Day 8 (the day after the end of the intervention)
Intensity of anxious symptoms using the State Anxiety Inventory- State (SAI-State)
Reduction of anxious symptoms between the beginning and the end of the intervention, using the State Anxiety Inventory- State (SAI-State)
Measured: Day 8 (the day after the end of the intervention)
Perceived usefulness of the intervention using a likert scale
Evaluation of the perceived usefulness of each intervention, using a likert scale.
Measured: Day 8 (the day after the end of the intervention)
Intensity of suicidal ideation
Reduction of suicidal ideation intensity, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Measured: At day 1, 2, 3,4 5, 6, 7
Intensity of hopelessness
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Measured: At day 1, 2, 3, 4, 5, 6, 7
Intensity of optimism
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Measured: At day 1, 2, 3, 4, 5, 6, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal ThoughtsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855736
- Sponsor's protocol ID
- UF 9557
- Other IDs
- 2015-A00358-41
- Acronym
- POPS
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Positive Psychology in Suicidal Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02855736
- Acronym / sponsor ID
- POPS / UF 9557
- Conditions
- Suicidal Thoughts, Suicidal Crisis
- Keywords
- Suicidal inpatients, Positive Psychology, Gratitude, Psychological pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 4 Aug 2016 (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.
Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide risk period for those having current suicidal ideation or attempt. Recently, a pilot study suggested the feasibility of positive psychology in patients in suicidal crisis. Notably, gratitude exercises suggested improvement in optimism and hopelessness, two dimensions associated to suicide. Moreover, gratitude has been associated to suicidal ideation and attempt, independently from depression. Thus, investigators want to conduct the first randomized controlled study in order to assess effectiveness of gratitude exercises (vs control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.
Detailed description
Study design: monocentric randomized controlled study
Methods:
206 inpatients (Department of Emergency Psychiatry and Post Acute Care), between 18 and 65 years-old, having attempted suicide before hospitalisation or having current active suicidal ideation at the time of the psychiatric hospitalisation. Patients suffering from schizophrenia are excluded.
Randomization into two groups: Positive Psychology (i.e., gratitude journal) (n = 103) or Control Task (i.e., food journal) (n = 103), daily exercises during 7 days (in add-on from usual treatment).
Clinical assessment: 1) at baseline (the day before the intervention beginning) (V0); 2) short daily self-assessments (immediately before and after the exercise); 3) the day following the last day of the intervention (V1).
- V0 : socio-demographic data, treatments, psychopathology, suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness.
- Daily self-assessments: psychological pain, optimism, hopelessness
- V1 : treatments suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness, intervention satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Positive PsychologyPositive Psychology (gratitude journal) |
| Control group | Placebo comparator | Behavioral: Placebo (food journal)Alimentary list |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being hospitalized for suicidal thoughts or suicide attempt (from less than a week)
- Having signed informed consent
- Be fluent in French
- Able to understand nature, aims and methodology of the study
Key exclusion criteria (4 listed)
- Lifetime history of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria
- Current eating disorder according to DSM-V criteria
- Patient on protective measures (guardianship or trusteeship)
- Deprived of liberty subject (judicial or administrative decision)
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 PsychologyGratitude Journal (Emmons and Stern, 2013) Every evening, patients have to write down the things they feel grateful about. | Behavioural | Intervention group |
| Placebo (food journal)Food journal (i.e. alimentary list): Patients have to write down the list of foods eaten during the day. | Behavioural | Control group |
Primary outcome
Psychological pain reduction using a likert scale
Time frame: At the inclusion and day 8 (the day after the end of the intervention)
Psychological pain reduction, in gratitude vs control group, between the beginning and the end of the intervention, using a likert scale.
10 secondary outcomes
Psychological pain reduction using a likert scale
Time frame: At day 1, 2, 3, 4, 5, 6, 7
intensity of suicidal ideation
Time frame: At the inclusion and day 8 (the day after the end of the intervention)
Intensity of hopelessness
Time frame: At the inclusion and day 8 (the day after the end of the intervention)
Intensity of optimism
Time frame: At the inclusion and day 8 (the day after the end of the intervention)
Intensity of depressive symptoms using the Beck Depression Inventory (BDI)
Time frame: Day 8 (the day after the end of the intervention)
Intensity of anxious symptoms using the State Anxiety Inventory- State (SAI-State)
Time frame: Day 8 (the day after the end of the intervention)
Perceived usefulness of the intervention using a likert scale
Time frame: Day 8 (the day after the end of the intervention)
Intensity of suicidal ideation
Time frame: At day 1, 2, 3,4 5, 6, 7
Intensity of hopelessness
Time frame: At day 1, 2, 3, 4, 5, 6, 7
Intensity of optimism
Time frame: At day 1, 2, 3, 4, 5, 6, 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: No
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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.
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 in people with Suicidal Thoughts and Suicidal Crisis, run by University Hospital, Montpellier at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Aug 2016. 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 France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Déborah DUCASSE, MD PhD (+33 4 67 33 85 81, d-ducasse@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological pain reduction using a likert scale (time frame: At the inclusion and day 8 (the day after the end of the intervention)). 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 4 Aug 2016.