Adjustment DisordersSeren@ctifNCT02621775

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

A study testing Computer-based stress management program, Stress management in face-to-face and Waiting list in people with Adjustment Disorders and Psychological Stress, run by University Hospital, Lille at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Adjustment Disorders, Psychological Stress
What is being tested?: Computer-based stress management program, Stress management in face-to-face and Waiting list
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 3 sitesFrance
Study dates: 14 Sep 2015to 16 Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Subscore anxiety < 10, subscore depression > 10 at Hospital Anxiety Depression Scale (HADS)
No others current psychiatric diagnostic according DSM- 5
No suicidal ideation

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre Pinel
Amiens
Centre Esquirol CHU de Caen
Caen
CHRU , Hôpital FONTAN
Lille

Other trials in France

About this study

Official 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

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.

Conditions: Adjustment Disorders, Psychological Stress
Being tested: Computer-based stress management program, Stress management in face-to-face, Waiting list
Keywords: Stress management, Cognitive behavioural therapy (CBT), Self-help, e-health, Adjustment disorder with anxiety
Medical subject headings: Adjustment Disorders, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computer-based stress management programBehavioural
Also called Seren@ctif
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.
Stress management in face-to-faceBehavioural
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 listOther
The patients are followed by their General Practitioners without change in treatment .

Study groups in NCT02621775
Study group	Role	What they receive
Computer-based stress management program	Experimental	Immediate e-learning condition with minimal contact (n =40), Receives: Behavioral: Computer-based stress management program
Stress management in face-to-face	Experimental	Immediate treatment in face - to- face (n = 40) Receives: Behavioral: Stress management in face-to-face
Waiting list	Other	Waiting list (n=40) Receives: Other: Waiting list

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Between baseline and 2 month of use

Secondary outcomes (5)

Hospital Anxiety and Depression scale (HAD),
The scale allows to detect anxiety and depression using 14 items rated from 0-3.
Measured: 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.
Measured: at 2 months, at 6 months
The Perceived Stress Scale (PSS)
Two dimensions emerge from this scale: the overflow and perceived self-efficacy.
Measured: at 2 months, at 6 months
Visual Analogue Scale for stress (VAS-stress)
Measured: at 2 months, at 6 months
The Beck depression inventory (BDI-21)
Self-assessment questionnaire measuring the severity of depression
Measured: at 2 months, at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 201516 Jun 2018

First posted3 Dec 2015 (estimated)
Study start14 Sep 2015
Primary completion16 Jun 2018
Study completion16 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Adjustment DisordersStudies of the same condition, open and under way.
More trials run by University Hospital, LilleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02621775
Sponsor's protocol ID: 2014_36
Other IDs: 2015-A00098-41, PHRCI_2014
Acronym: Seren@ctif
Status last verified: Jun 2019
First submitted: 26 Nov 2015
Last updated: 22 Dec 2025
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02621775
Acronym / sponsor ID: Seren@ctif / 2014_36
Conditions: Adjustment Disorders, Psychological Stress
Keywords: Stress management, Cognitive behavioural therapy (CBT), Self-help, e-health, Adjustment disorder with anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University Hospital, LilleUniversity, hospital or other
Collaborators: Ministry of Health, France
Study start: 14 Sep 2015 (actual)
Primary completion: 16 Jun 2018 (actual)
Study completion: 16 Jun 2018 (actual)
First posted: 3 Dec 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Computer-based stress management program	Experimental	Behavioral: Computer-based stress management programImmediate e-learning condition with minimal contact (n =40),
Stress management in face-to-face	Experimental	Behavioral: Stress management in face-to-faceImmediate treatment in face - to- face (n = 40)
Waiting list	Other	Other: Waiting listWaiting list (n=40)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

Subscore anxiety < 10, subscore depression > 10 at Hospital Anxiety Depression Scale (HADS)
No others current psychiatric diagnostic according DSM- 5
No suicidal ideation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computer-based stress management programAlso: Seren@ctifThe 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.	Behavioural	Computer-based stress management program
Stress management in face-to-faceThe 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.	Behavioural	Stress management in face-to-face
Waiting listThe patients are followed by their General Practitioners without change in treatment .	Other	Waiting list

Primary outcome

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.

5 secondary outcomes

Hospital Anxiety and Depression scale (HAD),
Time frame: at 2 months, at 6 months
The Penn-State Worry Questionnaire (PSWQ),
Time frame: at 2 months, at 6 months
The Perceived Stress Scale (PSS)
Time frame: at 2 months, at 6 months
Visual Analogue Scale for stress (VAS-stress)
Time frame: at 2 months, at 6 months
The Beck depression inventory (BDI-21)
Time frame: at 2 months, at 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Background: PubMed 23639300Day 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.
Background: PubMed 23607962Drozd 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.
BackgroundEisen 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.
Background: PubMed 15289593Grime 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.
Background: PubMed 23262118Rose 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.
Background: PubMed 17852171Ruwaard 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.
Background: PubMed 27126141Servant 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.
Results publication: PubMed 32523873Leterme 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.
Derived from this study: PubMed 28970192Servant 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dominique Servant, MD principal investigator

University Hospital, Lille

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of State-Trait Anxiety Inventory (STAI-S), (time frame: Between baseline and 2 month of use). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02621775, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.