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

Not Applicable

Completed

• Conditions: Psychological Stress; Adjustment Disorders

• 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.

Study Timeline

• Study Start: 2015-09-14
• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Primary Completion: 2018-06-16
• Study Completion: 2018-06-16
• Status Verified: 2019-06
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Centre Esquirol CHU de Caen; 🇫🇷 Caen, France

CHRU , Hôpital FONTAN; 🇫🇷 Lille, France