AnxietyNCT03496350
Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
A study testing Internet-delivered CBT in people with Anxiety and Depression, run by Linkoeping University at 1 site in Sweden.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Internet-delivered CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- 7 Jan 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
- Recent (during last 4 weeks) change in psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Adapted Transdiagnostic Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
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
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Internet-delivered CBT
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBTBehavioural
Culturally adapted transdiagnostic internet-delivered CBT in Arabic
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | Internet-based cognitive behavioural therapy in Arabic with therapeutic guidance through email. Receives: Behavioral: Internet-delivered CBT |
| Wait-list | No intervention | Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-treatment, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start7 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants get randomly assigned to either treatment or wait-list control.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496350
- Sponsor's protocol ID
- SAHA
- Status last verified
- Feb 2020
- First submitted
- 29 Mar 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Transdiagnostic Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
- ClinicalTrials.gov ID
- NCT03496350
- Acronym / sponsor ID
- SAHA
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants get randomly assigned to either treatment or wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet-delivered CBTInternet-based cognitive behavioural therapy in Arabic with therapeutic guidance through email. |
| Wait-list | No intervention | –Wait-list control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
- Recent (during last 4 weeks) change in psychiatric medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered CBTCulturally adapted transdiagnostic internet-delivered CBT in Arabic | Behavioural | Internet CBT |
Primary outcome
Change in Patient Health Questionnaire (PHQ-9)
Time frame: pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
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)
Time frame: pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment
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.
5 secondary outcomes
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: pre-treatment, week 8
Insomnia Severity Index (ISI)
Time frame: pre-treatment, week 8
Impact of Events Scale - Revised (IES-R)
Time frame: pre-treatment, week 8
Perceived Stress Scale (PSS)
Time frame: pre-treatment, week 8
"Brunnsviken Brief Quality of Life Scale" (BBQ)
Time frame: pre-treatment, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered CBT in people with Anxiety and Depression, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (PHQ-9) (time frame: pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.