ClinicalTrials.gg
CompletedNCT02621775Seren@ctifUpdated Dec 22, 2025

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

An interventional study of Computer-based stress management program and Stress management in face-to-face in Adjustment Disorders and Psychological Stress, sponsored by University Hospital, Lille. Completed at 3 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 .

Read the 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.
02

Conditions studied

  • Adjustment Disorders
  • Psychological Stress

Keywords

  • Stress management
  • Cognitive behavioural therapy (CBT)
  • Self-help
  • e-health
  • Adjustment disorder with anxiety
03

In context

Adjustment Disorders

63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.

Browse Adjustment Disorders studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adjustment disorder with anxiety (ADA) according (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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Computer-based stress management program

    Immediate e-learning condition with minimal contact (n =40),

    Behavioral: Computer-based stress management program

  • Experimental
    Stress management in face-to-face

    Immediate treatment in face - to- face (n = 40)

    Behavioral: Stress management in face-to-face

  • Other
    Waiting list

    Waiting list (n=40)

    Other: Waiting list

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.

    Also known as: Seren@ctif

  • 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 .

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Between baseline and 2 month of use

Secondary outcomes

  1. Hospital Anxiety and Depression scale (HAD),

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

    Time frame: at 2 months, at 6 months

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

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

    Time frame: at 2 months, at 6 months

  3. The Perceived Stress Scale (PSS)

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

    Time frame: at 2 months, at 6 months

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

    Time frame: at 2 months, at 6 months

  5. The Beck depression inventory (BDI-21)

    Self-assessment questionnaire measuring the severity of depression

    Time frame: at 2 months, at 6 months

07

Study locations

3 sites
  • Centre Pinel
    Amiens, France
  • Centre Esquirol CHU de Caen
    Caen, France
  • CHRU , Hôpital FONTAN
    Lille, France
08

References and documents

Publications

  • Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28. PubMed 23639300 ↗
  • Drozd F, Raeder S, Kraft P, Bjorkli CA. Multilevel growth curve analyses of treatment effects of a Web-based intervention for stress reduction: randomized controlled trial. J Med Internet Res. 2013 Apr 22;15(4):e84. doi: 10.2196/jmir.2570. PubMed 23607962 ↗
  • Eisen KP, Allen GJ, Bollash M, Pescatello LS. Stress management in the workplace: A comparison of a computer-based and an in-person stress-management intervention. Comput Hum Behav. 2008 Mar;24(2):486-96.
  • Grime PR. Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism. Occup Med (Lond). 2004 Aug;54(5):353-9. doi: 10.1093/occmed/kqh077. PubMed 15289593 ↗
  • Rose RD, Buckey JC Jr, Zbozinek TD, Motivala SJ, Glenn DE, Cartreine JA, Craske MG. A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Behav Res Ther. 2013 Feb;51(2):106-12. doi: 10.1016/j.brat.2012.11.003. Epub 2012 Nov 21. PubMed 23262118 ↗
  • Ruwaard J, Lange A, Bouwman M, Broeksteeg J, Schrieken B. E-mailed standardized cognitive behavioural treatment of work-related stress: a randomized controlled trial. Cogn Behav Ther. 2007;36(3):179-92. doi: 10.1080/16506070701381863. PubMed 17852171 ↗
  • Servant D, Rougegrez L, Barasino O, Demarty AL, Duhamel A, Vaiva G. [Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program]. Encephale. 2016 Oct;42(5):415-420. doi: 10.1016/j.encep.2016.03.010. Epub 2016 Apr 25. French. PubMed 27126141 ↗
  • Leterme AC, Behal H, Demarty AL, Barasino O, Rougegrez L, Labreuche J, Duhamel A, Vaiva G, Servant D. A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial. Internet Interv. 2020 May 25;21:100329. doi: 10.1016/j.invent.2020.100329. eCollection 2020 Sep. PubMed 32523873 ↗
  • Servant D, Leterme AC, Barasino O, Rougegrez L, Duhamel A, Vaiva G. Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial. JMIR Res Protoc. 2017 Oct 2;6(10):e190. doi: 10.2196/resprot.7976. PubMed 28970192 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2015 to primary completion in Jun 2018, 33 months.

Of 25 interventional studies with no phase under Adjustment Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 33 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2015
First posted
Dec 3, 2015
StartActual
Sep 14, 2015
Primary completionActual
Jun 16, 2018
CompletionActual
Jun 16, 2018
Last update
Dec 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02621775
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Dec 3, 2015
Start date
Sep 14, 2015
Primary completion
Jun 16, 2018
Completion
Jun 16, 2018
Last update
Dec 22, 2025

Study contacts

Dominique Servant, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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