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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02621775
Acronym
Seren@ctif
Enrollment
120
Registered
2015-12-03
Start date
2015-09-14
Completion date
2018-06-16
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjustment Disorders, Psychological Stress

Keywords

Stress management, Cognitive behavioural therapy (CBT), Self-help, e-health, Adjustment disorder with anxiety

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.

Interventions

BEHAVIORALComputer-based stress management program

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.

BEHAVIORALStress management in face-to-face

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.

OTHERWaiting list

The patients are followed by their General Practitioners without change in treatment .

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score of State-Trait Anxiety Inventory (STAI-S),Between baseline and 2 month of useself-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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026