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

University Hospital, Lille

Status: Completed

Conditions: Adjustment Disorders; Psychological Stress

Treatments: Behavioral: Computer-based stress management program; Other: Waiting list; Behavioral: Stress management in face-to-face

Study type: Interventional

Funder types: Other

Identifiers

NCT02621775

PHRCI_2014 (Other Identifier)

2014_36

2015-A00098-41 (Other Identifier)

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Computer-based stress management program

Experimental group

Description:

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

Treatment:

Behavioral: Computer-based stress management program

Stress management in face-to-face

Experimental group

Description:

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

Treatment:

Behavioral: Stress management in face-to-face

Waiting list

Other group

Description:

Waiting list (n=40)

Treatment:

Other: Waiting list