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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adjustment Disorders, Psychological Stress

Intervention / Treatment
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* Behavioral: Computer-based stress management program
* Behavioral: Stress management in face-to-face
* Other: Waiting list


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-based stress management program<br>Immediate e-learning condition with minimal contact (n =40), | Behavioral: Computer-based stress management program<br>* The program includes 5 one hour weekly sessions that patient follow from a web site accessible from a computer in our unit. He benefits from a minimal contact with a medical member of staff before and after every session. The duration of each session is about one hour. To avoid internet connexion problem between session it is supplied to the patient, from the first session an USB key (Universal Serial Bus) containing videos, audio files, self help book, portfolio in the form of e-guide, log book with the program of the exercises to be realized between two session of the five sessions program. The patient is encouraged to practice a twenty-minutes daily exercises five or six days per week.<br>* Other names: Seren@ctif;|
| Experimental: Stress management in face-to-face<br>Immediate treatment in face - to- face (n = 40) | Behavioral: Stress management in face-to-face<br>* The program includes 5 forty-five minutes weekly session with a therapist (psychologist graduate of a master of cognitive and emotional therapy with a minimal of one year of practice in CBT and CBSM (Cognitive-Behavioral Stress Management ). Information, exercises and homework assignments are delivered by the therapist without self help support.<br>|
| Other: Waiting list<br>Waiting list (n=40) | Other: Waiting list<br>* The patients are followed by their General Practitioners without change in treatment .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of State-Trait Anxiety Inventory (STAI-S), | 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. | Between baseline and 2 month of use | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress management, Cognitive behavioural therapy (CBT), Self-help, e-health, Adjustment disorder with anxiety