Positive Psychology in Suicidal Patients (POPS)

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.

Study Overview

• Status: Unknown
• Conditions: Suicidal Thoughts; Suicidal Crisis
• Intervention / Treatment: Behavioral: Positive Psychology; Behavioral: Placebo (food journal)

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 Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France
      • Recruiting
      • Contact: Catherine Genty, MD; Phone Number: +33 4 67 61 45 75; Email: c-genty@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Positive Psychology (gratitude journal)	Behavioral: Positive Psychology; Gratitude Journal (Emmons and Stern, 2013) Every evening, patients have to write down the things they feel grateful about.
Placebo Comparator: Control group; Alimentary list	Behavioral: Placebo (food journal); Food journal (i.e. alimentary list): Patients have to write down the list of foods eaten during the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the inclusion and day 8 (the day after the end of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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)	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)	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.	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.	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.	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.	At day 1, 2, 3, 4, 5, 6, 7

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Positive Psychology; Gratitude; Suicidal inpatients; Psychological pain
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: UF 9557; 2015-A00358-41 (Other Identifier: FRANCE: Agence Nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO