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Completed

NCT Number: NCT02621775

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

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 .

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Key information

Conditions

Adjustment Disorders Behavior Behavioral Symptoms Mental Disorders Psychological Stress Stress, Psychological Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Pinel, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-based stress management program

Behavioral

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.

Other names: Seren@ctif

Stress management in face-to-face

Behavioral

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.

Waiting List

Other

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

Primary outcomes

  1. 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

  1. Hospital Anxiety and Depression scale (HAD),

    Time frame: at 2 months, at 6 months

    The scale allows to detect anxiety and depression using 14 items rated from 0-3.

  2. The Penn-State Worry Questionnaire (PSWQ),

    Time frame: at 2 months, at 6 months

    Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.

  3. The Perceived Stress Scale (PSS)

    Time frame: at 2 months, at 6 months

    Two dimensions emerge from this scale: the overflow and perceived self-efficacy.

  4. Visual Analogue Scale for stress (VAS-stress)

    Time frame: at 2 months, at 6 months

  5. The Beck depression inventory (BDI-21)

    Time frame: at 2 months, at 6 months

    Self-assessment questionnaire measuring the severity of depression

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: Seren@ctif

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2015
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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