Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Primary Purpose
Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered CBT
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Be above 18 years of age
- Have symptoms of anxiety and/or depression
- Be able to read and write in Arabic
- Have access to computer or smartphone
Exclusion Criteria:
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
- Recent (during last 4 weeks) change in psychiatric medication
Sites / Locations
- Linköping University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet CBT
Wait-list
Arm Description
Internet-based cognitive behavioural therapy in Arabic with therapeutic guidance through email.
Wait-list control
Outcomes
Primary Outcome Measures
Change in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a nine-item self-report questionnaire that measures symptoms of depression. It is scored from 0-27 with a higher score reflecting more severe symptoms.
Change in Generalised Anxiety Disorder-7-item scale, (GAD-7)
The GAD-7 is a seven-item self-report questionnaire that measures symptoms of anxiety. It is scored from 0-21 with a higher score reflecting more severe symptoms.
Secondary Outcome Measures
Alcohol Use Disorder Identification Test (AUDIT)
Measures alcohol consumption, drinking behaviors, and alcohol-related problems. It is scored from 0-40 with higher scores reflecting more alcohol consumption, drinking behaviors, and alcohol-related problems.
Insomnia Severity Index (ISI)
Self-reported symptoms of insomnia. It is scored from 0-28 with higher scores reflecting more symptoms of insomnia.
Impact of Events Scale - Revised (IES-R)
Self-reported symptoms of post-traumatic stress. It is scored from 0-88 where higher scores reflect more symptoms.
Perceived Stress Scale (PSS)
Self-reported stress-related symptoms. It is scored from 0-56 with higher scores reflecting more symtoms of perceived stress.
"Brunnsviken Brief Quality of Life Scale" (BBQ)
Self-reported quality of life. The scale is scored from 0-96 with a higher score reflecting higher self-reported quality of life.
Full Information
NCT ID
NCT03496350
First Posted
March 29, 2018
Last Updated
February 19, 2020
Sponsor
Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT03496350
Brief Title
Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Official Title
Culturally Adapted Transdiagnostic Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of a culturally adapted internet-administrated cognitive behaviour therapy (ICBT) in Arabic for anxiety and depression
Detailed Description
The study will compare the effect of the intervention against a wait-list control. The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform. Participants in the study are recruited from the general public via social media. The intervention is in Arabic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants get randomly assigned to either treatment or wait-list control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet CBT
Arm Type
Experimental
Arm Description
Internet-based cognitive behavioural therapy in Arabic with therapeutic guidance through email.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
Wait-list control
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered CBT
Intervention Description
Culturally adapted transdiagnostic internet-delivered CBT in Arabic
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 is a nine-item self-report questionnaire that measures symptoms of depression. It is scored from 0-27 with a higher score reflecting more severe symptoms.
Time Frame
pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
Title
Change in Generalised Anxiety Disorder-7-item scale, (GAD-7)
Description
The GAD-7 is a seven-item self-report questionnaire that measures symptoms of anxiety. It is scored from 0-21 with a higher score reflecting more severe symptoms.
Time Frame
pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
Secondary Outcome Measure Information:
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
Measures alcohol consumption, drinking behaviors, and alcohol-related problems. It is scored from 0-40 with higher scores reflecting more alcohol consumption, drinking behaviors, and alcohol-related problems.
Time Frame
pre-treatment, week 8
Title
Insomnia Severity Index (ISI)
Description
Self-reported symptoms of insomnia. It is scored from 0-28 with higher scores reflecting more symptoms of insomnia.
Time Frame
pre-treatment, week 8
Title
Impact of Events Scale - Revised (IES-R)
Description
Self-reported symptoms of post-traumatic stress. It is scored from 0-88 where higher scores reflect more symptoms.
Time Frame
pre-treatment, week 8
Title
Perceived Stress Scale (PSS)
Description
Self-reported stress-related symptoms. It is scored from 0-56 with higher scores reflecting more symtoms of perceived stress.
Time Frame
pre-treatment, week 8
Title
"Brunnsviken Brief Quality of Life Scale" (BBQ)
Description
Self-reported quality of life. The scale is scored from 0-96 with a higher score reflecting higher self-reported quality of life.
Time Frame
pre-treatment, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be above 18 years of age
Have symptoms of anxiety and/or depression
Be able to read and write in Arabic
Have access to computer or smartphone
Exclusion Criteria:
Suicidal ideation
Alcohol addiction
Other major primary psychiatric disorder
Ongoing psychological treatment
Recent (during last 4 weeks) change in psychiatric medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
581 83
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
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