Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Culturally Adapted Transdiagnostic Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: Internet-delivered CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants get randomly assigned to either treatment or wait-list control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet CBT<br>Internet-based cognitive behavioural therapy in Arabic with therapeutic guidance through email. | Behavioral: Internet-delivered CBT<br>* Culturally adapted transdiagnostic internet-delivered CBT in Arabic<br>|
| No Intervention: Wait-list<br>Wait-list control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment | 
| 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. | pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-treatment, week 8 | 
| Insomnia Severity Index (ISI) | Self-reported symptoms of insomnia. It is scored from 0-28 with higher scores reflecting more symptoms of insomnia. | pre-treatment, week 8 | 
| 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. | pre-treatment, week 8 | 
| Perceived Stress Scale (PSS) | Self-reported stress-related symptoms. It is scored from 0-56 with higher scores reflecting more symtoms of perceived stress. | pre-treatment, week 8 | 
| 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. | pre-treatment, week 8 |