Viewing Study NCT02621775



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Last Modification Date: 2024-10-26 @ 11:53 AM
Study NCT ID: NCT02621775
Status: COMPLETED
Last Update Posted: 2020-09-11
First Post: 2015-11-26

Brief Title: Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety ADA
Sponsor: University Hospital Lille
Organization: University Hospital Lille

Study Overview

Official Title: Effectiveness of Two Stress Management Programs in the Adaptation Disorder With Anxiety ADA Computer-based or Face- to -Face to Face Versus Control GroupOpen Multicenter Prospective Randomized Controlled Therapeutic 3 Parallel Groups
Status: COMPLETED
Status Verified Date: 2019-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Serenctif
Brief Summary: The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral treatment of stress management conducted via e-learning or face-to-face on patients responding to the diagnosis of adjustment disorder with anxiety ADA according to the DSM- 5 Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria
Detailed Description: The program includes 5 weekly sessions that the patient follows It is based on standard CBT Cognitive Behavioural Therapy principles and includes five modules information about stress and stress reaction and assessment deep respiration and relaxation techniques cognitive re-structuration mindfulness and acceptation behavioral skills as solving problem time management healthy behaviors problem solving and emotion regulation

In internet-based group patient benefits from a minimal contact with a medical member of staff before and after every session It is supplied to the patient from the first session an USB key containing videos audio files help-self book portfolio in the form of e-guide log books with the program of the exercises to be realized between two session of the 5 sessions program The patient is encouraged to practice a twenty-minutes daily of exercises five or six days per week
In face-to-face group patient receive the same program with a therapist in 5 weekly sessions without digital supports

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
PHRCI_2014 OTHER PHRC number DGOS None
2015-A00098-41 OTHER None None