Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA) (Seren@ctif)
Primary Purpose
Adjustment Disorders, Psychological Stress
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computer-based stress management program
Stress management in face-to-face
Waiting list
Sponsored by
About this trial
This is an interventional prevention trial for Adjustment Disorders focused on measuring Stress management, Cognitive behavioural therapy (CBT), Self-help, e-health, Adjustment disorder with anxiety
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
Sites / Locations
- Centre Pinel
- Centre Esquirol CHU de Caen
- CHRU , Hôpital FONTAN
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Computer-based stress management program
Stress management in face-to-face
Waiting list
Arm Description
Immediate e-learning condition with minimal contact (n =40),
Immediate treatment in face - to- face (n = 40)
Waiting list (n=40)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hospital Anxiety and Depression scale (HAD),
The scale allows to detect anxiety and depression using 14 items rated from 0-3.
The Penn-State Worry Questionnaire (PSWQ),
Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.
The Perceived Stress Scale (PSS)
Two dimensions emerge from this scale: the overflow and perceived self-efficacy.
Visual Analogue Scale for stress (VAS-stress)
The Beck depression inventory (BDI-21)
Self-assessment questionnaire measuring the severity of depression
Full Information
NCT ID
NCT02621775
First Posted
November 26, 2015
Last Updated
September 9, 2020
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT02621775
Brief Title
Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 14, 2015 (Actual)
Primary Completion Date
June 16, 2018 (Actual)
Study Completion Date
June 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Disorders, Psychological Stress
Keywords
Stress management, Cognitive behavioural therapy (CBT), Self-help, e-health, Adjustment disorder with anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-based stress management program
Arm Type
Experimental
Arm Description
Immediate e-learning condition with minimal contact (n =40),
Arm Title
Stress management in face-to-face
Arm Type
Experimental
Arm Description
Immediate treatment in face - to- face (n = 40)
Arm Title
Waiting list
Arm Type
Other
Arm Description
Waiting list (n=40)
Intervention Type
Behavioral
Intervention Name(s)
Computer-based stress management program
Other Intervention Name(s)
Seren@ctif
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress management in face-to-face
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting list
Intervention Description
The patients are followed by their General Practitioners without change in treatment .
Primary Outcome Measure Information:
Title
Score of State-Trait Anxiety Inventory (STAI-S),
Description
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.
Time Frame
Between baseline and 2 month of use
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression scale (HAD),
Description
The scale allows to detect anxiety and depression using 14 items rated from 0-3.
Time Frame
at 2 months, at 6 months
Title
The Penn-State Worry Questionnaire (PSWQ),
Description
Self-Assessment Questionnaire consisting of 16 items, measuring the general tendency to worry.
Time Frame
at 2 months, at 6 months
Title
The Perceived Stress Scale (PSS)
Description
Two dimensions emerge from this scale: the overflow and perceived self-efficacy.
Time Frame
at 2 months, at 6 months
Title
Visual Analogue Scale for stress (VAS-stress)
Time Frame
at 2 months, at 6 months
Title
The Beck depression inventory (BDI-21)
Description
Self-assessment questionnaire measuring the severity of depression
Time Frame
at 2 months, at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Servant, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Pinel
City
Amiens
Country
France
Facility Name
Centre Esquirol CHU de Caen
City
Caen
Country
France
Facility Name
CHRU , Hôpital FONTAN
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23639300
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
23262118
Citation
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Results Reference
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PubMed Identifier
17852171
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.
Results Reference
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PubMed Identifier
27126141
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.
Results Reference
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PubMed Identifier
32523873
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.
Results Reference
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28970192
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.
Results Reference
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Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)
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