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

Psychological Stress Clinical Trial

— Seren@ctif  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621775
• Other study ID #: 2014_36
• Secondary ID: 2015-A00098-41PH
• Status: Completed
• Phase: N/A
• Start date: September 14, 2015
• Est. completion date: June 16, 2018

Study information

• Verified date: June 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Disorders Fifth Edition) criteria .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 16, 2018
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjustment Disorders
• Disease
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Computer-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.
• Stress 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.

Other:
• Waiting list
The patients are followed by their General Practitioners without change in treatment .

Locations

Country	Name	City	State
France	Centre Pinel	Amiens
France	Centre Esquirol CHU de Caen	Caen
France	CHRU , Hôpital FONTAN	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

Drozd F, Raeder S, Kraft P, Bjørkli 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. — View 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.

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital Anxiety and Depression scale (HAD),	The scale allows to detect anxiety and depression using 14 items rated from 0-3.	at 2 months, at 6 months
Secondary	The Penn-State Worry Questionnaire (PSWQ),	Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.	at 2 months, at 6 months
Secondary	The Perceived Stress Scale (PSS)	Two dimensions emerge from this scale: the overflow and perceived self-efficacy.	at 2 months, at 6 months
Secondary	Visual Analogue Scale for stress (VAS-stress)		at 2 months, at 6 months
Secondary	The Beck depression inventory (BDI-21)	Self-assessment questionnaire measuring the severity of depression	at 2 months, at 6 months