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Clinical Trials/NCT02621775
NCT02621775
Completed
Not Applicable

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 Controlled Therapeutic 3 Parallel Groups

University Hospital, Lille3 sites in 1 country120 target enrollmentSeptember 14, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adjustment Disorders
Sponsor
University Hospital, Lille
Enrollment
120
Locations
3
Primary Endpoint
Score of State-Trait Anxiety Inventory (STAI-S),
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2015
End Date
June 16, 2018
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adjustment disorder with anxiety (ADA) according DSM-5 (The diagnosis was made according to the MINI questionnaire).
  • Subscore anxiety \> 10, subscore depression \< 10 at Hospital Anxiety Depression Scale (HADS)
  • Computer at home

Exclusion Criteria

  • Subscore anxiety \< 10, subscore depression \> 10 at Hospital Anxiety Depression Scale (HADS)
  • No others current psychiatric diagnostic according DSM- 5
  • No suicidal ideation

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The Penn-State Worry Questionnaire (PSWQ),(at 2 months, at 6 months)
  • The Perceived Stress Scale (PSS)(at 2 months, at 6 months)
  • Visual Analogue Scale for stress (VAS-stress)(at 2 months, at 6 months)
  • Hospital Anxiety and Depression scale (HAD),(at 2 months, at 6 months)
  • The Beck depression inventory (BDI-21)(at 2 months, at 6 months)

Study Sites (3)

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