Positive Psychology in Suicidal Patients

Suicidal Thoughts Clinical Trial

— POPS  

Official title:

Effectiveness of Positive Psychology in Suicidal Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855736
• Other study ID #: UF 9557
• Secondary ID: 2015-A00358-41
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2016
• Last updated: August 1, 2016
• Start date: September 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: Déborah DUCASSE, MD PhD
• Phone: +33 4 67 33 85 81
• Email: d-ducasse[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Suicidal Crisis
• Suicidal Ideation
• Suicidal Thoughts

Intervention

Behavioral:
• Positive Psychology
Gratitude Journal (Emmons and Stern, 2013) Every evening, patients have to write down the things they feel grateful about.
• Placebo (food journal)
Food journal (i.e. alimentary list): Patients have to write down the list of foods eaten during the day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No