Positive Psychology in Suicidal Patients (POPS)
Primary Purpose
Suicidal Thoughts, Suicidal Crisis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positive Psychology
Placebo (food journal)
Sponsored by
About this trial
This is an interventional supportive care trial for Suicidal Thoughts focused on measuring Suicidal inpatients, Positive Psychology, Gratitude, Psychological pain
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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)
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
Positive Psychology (gratitude journal)
Alimentary list
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
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).
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)
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)
Perceived usefulness of the intervention using a likert scale
Evaluation of the perceived usefulness of each intervention, using a likert scale.
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.
Intensity of hopelessness
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Intensity of optimism
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Full Information
NCT ID
NCT02855736
First Posted
July 8, 2016
Last Updated
August 1, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02855736
Brief Title
Positive Psychology in Suicidal Patients
Acronym
POPS
Official Title
Effectiveness of Positive Psychology in Suicidal Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Thoughts, Suicidal Crisis
Keywords
Suicidal inpatients, Positive Psychology, Gratitude, Psychological pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Positive Psychology (gratitude journal)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Alimentary list
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychology
Intervention Description
Gratitude Journal (Emmons and Stern, 2013)
Every evening, patients have to write down the things they feel grateful about.
Intervention Type
Behavioral
Intervention Name(s)
Placebo (food journal)
Intervention Description
Food journal (i.e. alimentary list):
Patients have to write down the list of foods eaten during the day.
Primary Outcome Measure Information:
Title
Psychological pain reduction using a likert scale
Description
Psychological pain reduction, in gratitude vs control group, between the beginning and the end of the intervention, using a likert scale.
Time Frame
At the inclusion and day 8 (the day after the end of the intervention)
Secondary Outcome Measure Information:
Title
Psychological pain reduction using a likert scale
Description
Psychological pain reduction, in gratitude vs control group, the beginning and the end of each exercise, using a likert scale.
Time Frame
At day 1, 2, 3, 4, 5, 6, 7
Title
intensity of suicidal ideation
Description
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).
Time Frame
At the inclusion and day 8 (the day after the end of the intervention)
Title
Intensity of hopelessness
Description
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).
Time Frame
At the inclusion and day 8 (the day after the end of the intervention)
Title
Intensity of optimism
Description
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).
Time Frame
At the inclusion and day 8 (the day after the end of the intervention)
Title
Intensity of depressive symptoms using the Beck Depression Inventory (BDI)
Description
Reduction of depressive symptoms between the beginning and the end of the intervention, using the Beck Depression Inventory (BDI)
Time Frame
Day 8 (the day after the end of the intervention)
Title
Intensity of anxious symptoms using the State Anxiety Inventory- State (SAI-State)
Description
Reduction of anxious symptoms between the beginning and the end of the intervention, using the State Anxiety Inventory- State (SAI-State)
Time Frame
Day 8 (the day after the end of the intervention)
Title
Perceived usefulness of the intervention using a likert scale
Description
Evaluation of the perceived usefulness of each intervention, using a likert scale.
Time Frame
Day 8 (the day after the end of the intervention)
Title
Intensity of suicidal ideation
Description
Reduction of suicidal ideation intensity, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Time Frame
At day 1, 2, 3,4 5, 6, 7
Title
Intensity of hopelessness
Description
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Time Frame
At day 1, 2, 3, 4, 5, 6, 7
Title
Intensity of optimism
Description
Reduction of hopelessness, in gratitude vs control group between the beginning and the end of each exercise, using a Likert Scale.
Time Frame
At day 1, 2, 3, 4, 5, 6, 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Déborah DUCASSE, MD PhD
Phone
+33 4 67 33 85 81
Email
d-ducasse@chu-montpellier.fr
Facility Information:
City
Montpellier
State/Province
Hérault
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Genty, MD
Phone
+33 4 67 61 45 75
Email
c-genty@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Positive Psychology in Suicidal Patients
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