NCT02855736

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 4, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

July 8, 2016

Last Update Submit

August 1, 2016

Conditions

Suicidal ThoughtsSuicidal Crisis

Keywords

Suicidal inpatientsPositive PsychologyGratitudePsychological pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Psychological pain reduction using a likert scale

    At day 1, 2, 3, 4, 5, 6, 7

  • intensity of suicidal ideation

    At the inclusion and day 8 (the day after the end of the intervention)

  • Intensity of hopelessness

    At the inclusion and day 8 (the day after the end of the intervention)

  • Intensity of optimism

    At the inclusion and day 8 (the day after the end of the intervention)

  • Intensity of depressive symptoms using the Beck Depression Inventory (BDI)

    Day 8 (the day after the end of the intervention)

  • +5 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Positive Psychology (gratitude journal)

Behavioral: Positive Psychology

Control group

PLACEBO COMPARATOR

Alimentary list

Behavioral: Placebo (food journal)

Interventions

Positive PsychologyBEHAVIORAL

Gratitude Journal (Emmons and Stern, 2013) Every evening, patients have to write down the things they feel grateful about.

Intervention group
Placebo (food journal)BEHAVIORAL

Food journal (i.e. alimentary list): Patients have to write down the list of foods eaten during the day.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Montpellier, Hérault, France

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Psychology, Positive

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychologyBehavioral SciencesBehavioral Disciplines and Activities

Central Study Contacts

Déborah DUCASSE, MD PhD

CONTACT

+33 4 67 33 85 81d-ducasse@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

August 4, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

August 4, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)