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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00098-41 | Other Identifier | ID-RCB number, ANSM | |
| PHRCI_2014 | Other Identifier | PHRC number, DGOS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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 .
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 …).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-based stress management program | Experimental | Immediate e-learning condition with minimal contact (n =40), |
|
| Stress management in face-to-face | Experimental | Immediate treatment in face - to- face (n = 40) |
|
| Waiting list | Other | Waiting list (n=40) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Penn-State Worry Questionnaire (PSWQ), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Servant, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Pinel | Amiens | France | ||||
| Centre Esquirol CHU de Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23639300 | Background | 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. | |
| 23607962 | 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. |
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| ID | Term |
|---|---|
| D000275 | Adjustment Disorders |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| 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. |
|
| Waiting list | Other | The patients are followed by their General Practitioners without change in treatment . |
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Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.
| at 2 months, at 6 months |
| The Perceived Stress Scale (PSS) | Two dimensions emerge from this scale: the overflow and perceived self-efficacy. | 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) | Self-assessment questionnaire measuring the severity of depression | at 2 months, at 6 months |
| Caen |
| France |
| CHRU , Hôpital FONTAN | Lille | France |
| 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. |
| 15289593 | 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. |
| 23262118 | 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. |
| 17852171 | 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. |
| 27126141 | 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. |
| 32523873 | Result | 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. |
| 28970192 | Derived | 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. |