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

NCT02621775 | Completed

• 3 other identifiers: 2014_362015-A00098-41PHRCI_2014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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 .

Conditions

Adjustment Disorders; Psychological Stress

Keywords

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

Outcome Measures

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.

  Between baseline and 2 month of use

Secondary Outcomes (5)

• Hospital Anxiety and Depression scale (HAD),

  at 2 months, at 6 months

• The Penn-State Worry Questionnaire (PSWQ),

  at 2 months, at 6 months

• The Perceived Stress Scale (PSS)

  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)

  at 2 months, at 6 months

Study Arms (3)

Computer-based stress management program

EXPERIMENTAL

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

Behavioral: Computer-based stress management program

Stress management in face-to-face

EXPERIMENTAL

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

Behavioral: Stress management in face-to-face

Waiting list

OTHER

Waiting list (n=40)

Other: Waiting list

Interventions

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.

Stress management in face-to-face

Waiting list OTHER

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

Waiting list

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.

Also known as: Seren@ctif

Computer-based stress management program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (3)

Centre Pinel

Amiens, France

Location

Centre Esquirol CHU de Caen

Caen, France

Location

CHRU , Hôpital FONTAN

Lille, France

Location

Related Publications (9)

• 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.

  PMID: 23639300 BACKGROUND

• 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.

  PMID: 23607962 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15289593 BACKGROUND

• 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.

  PMID: 23262118 BACKGROUND

• 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.

  PMID: 17852171 BACKGROUND

• 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.

  PMID: 27126141 BACKGROUND

• 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.

  PMID: 32523873 RESULT

• 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.

  PMID: 28970192 DERIVED

MeSH Terms

Conditions

Adjustment Disorders; Stress, Psychological

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Dominique Servant, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 3, 2015
• Study Start: September 14, 2015
• Primary Completion: June 16, 2018
• Study Completion: June 16, 2018
• Last Updated: December 22, 2025

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)