Clinical trial NCT02621775: Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorders
Psychological Stress
Keywords: Stress management
Cognitive behavioural therapy (CBT)
Self-help
e-health
Adjustment disorder with anxiety
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-12-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score of State-Trait Anxiety Inventory (STAI-S),
timeFrame: Between baseline and 2 month of use
Secondary outcomes:
measure: Hospital Anxiety and Depression scale (HAD),
timeFrame: at 2 months, at 6 months
measure: The Penn-State Worry Questionnaire (PSWQ),
timeFrame: at 2 months, at 6 months
measure: The Perceived Stress Scale (PSS)
timeFrame: at 2 months, at 6 months
measure: Visual Analogue Scale for stress (VAS-stress)
timeFrame: at 2 months, at 6 months
measure: The Beck depression inventory (BDI-21)
timeFrame: at 2 months, at 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Pinel
city: Caen
country: France
facility: Centre Esquirol CHU de Caen
city: Lille
country: France
facility: CHRU , Hôpital FONTAN
Study officials:
affiliation: University Hospital, Lille
name: Dominique Servant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.