Clinical Trial: Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Group.Open Multicenter Prospective Randomized Co

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 Summary:

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.

Sponsor: University Hospital, Lille

Current Primary Outcome: Score of State-Trait Anxiety Inventory (STAI-S), [ Time Frame: Between baseline and 2 month of use ]

self-administered questionnaire of 20 items side on 4 levels from 'not at all' to one side "many" side 4 (total score of 20-80). It measures an intensity of more anxiety and is not related to an anxiety disorder.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hospital Anxiety and Depression scale (HAD), [ Time Frame: at 2 months, at 6 months ]
    The scale allows to detect anxiety and depression using 14 items rated from 0-3.
  • The Penn-State Worry Questionnaire (PSWQ), [ Time Frame: at 2 months, at 6 months ]
    Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.
  • The Perceived Stress Scale (PSS) [ Time Frame: at 2 months, at 6 months ]
    Two dimensions emerge from this scale: the overflow and perceived self-efficacy.
  • Visual Analogue Scale for stress (VAS-stress) [ Time Frame: at 2 months, at 6 months ]
  • The Beck depression inventory (BDI-21) [ Time Frame: at 2 months, at 6 months ]
    Self-assessment questionnaire measuring the severity of depression


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: November 26, 2015
Date Started: September 14, 2015
Date Completion: August 2018
Last Updated: May 18, 2017
Last Verified: May 2017