Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)
- Conditions
- Psychological StressAdjustment Disorders
- Interventions
- Behavioral: Computer-based stress management programOther: Waiting listBehavioral: Stress management in face-to-face
- Registration Number
- NCT02621775
- Lead Sponsor
- University Hospital, Lille
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- Subscore anxiety < 10, subscore depression > 10 at Hospital Anxiety Depression Scale (HADS)
- No others current psychiatric diagnostic according DSM- 5
- No suicidal ideation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Computer-based stress management program Computer-based stress management program Immediate e-learning condition with minimal contact (n =40), Waiting list Waiting list Waiting list (n=40) Stress management in face-to-face Stress management in face-to-face Immediate treatment in face - to- face (n = 40)
- Primary Outcome Measures
Name Time Method Score of State-Trait Anxiety Inventory (STAI-S), 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 Outcome Measures
Name Time Method The Penn-State Worry Questionnaire (PSWQ), at 2 months, at 6 months Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.
The Perceived Stress Scale (PSS) 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) at 2 months, at 6 months Hospital Anxiety and Depression scale (HAD), at 2 months, at 6 months The scale allows to detect anxiety and depression using 14 items rated from 0-3.
The Beck depression inventory (BDI-21) at 2 months, at 6 months Self-assessment questionnaire measuring the severity of depression
Trial Locations
- Locations (3)
Centre Pinel
🇫🇷Amiens, France
CHRU , Hôpital FONTAN
🇫🇷Lille, France
Centre Esquirol CHU de Caen
🇫🇷Caen, France