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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496350
Other study ID # SAHA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date December 1, 2019

Study information

Verified date February 2020
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet-delivered CBT
Culturally adapted transdiagnostic internet-delivered CBT in Arabic

Locations

Country Name City State
Sweden Linköping University Linköping

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary "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
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