DepressionNCT03720769
Testing e-Mental Health in Lebanon
A study testing Step-by-Step and Enhanced care as usual in people with Depression, run by VU University of Amsterdam at 1 site in Lebanon.
Trial summary
The study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Step-by-Step and Enhanced care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,248 participants
- Where
- 1 siteLebanon
- Study dates
- 9 Dec 2019to 20 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- PHQ-9 sum score above 9
- WHODAS 2.0 sum score above 16
Who cannot join
- Serious thoughts or plans to end one's life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention
The study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. First, a small study will be conducted to test the research procedure. Second, a large study will be conducted to test the effectiveness of Step-by-Step.
People residing in Lebanon (i.e. Lebanese, Palestinians and Syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. Minors (under the age of 18) and people who have plans to end their life will be excluded from the study.
Read more
To test whether the use of Step-by-Step improves symptoms of depression, two groups will be compared. Participants in the intervention group will receive Step-by-Step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. In addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. The study hypothesises that participants who receive Step-by-Step will have a higher symptom improvement than participants who receive basic information.
In order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: At the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).
- Conditions
- Depression
- Being tested
- Step-by-Step, Enhanced care as usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-by-StepBehavioural
Guided self-help programme delivered through an app/website for the treatment of depression
Enhanced care as usualBehavioural
Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)
| Study group | Role | What they receive |
|---|---|---|
| Step-by-Step | Experimental | Not described Receives: Behavioral: Step-by-Step |
| Enhanced care as usual | Active comparator | Not described Receives: Behavioral: Enhanced care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
Self-administered instrument for depression screening (intention-to-treat analysis)
Measured: 8 weeks
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Generic assessment instrument for health and disability (intention-to-treat analysis)
Measured: 8 weeks
Secondary outcomes (5)
WHO-5 Well-Being Index
Measured: 8 weeks
Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)
Measured: 8 weeks
PTSD Checklist for DSM-5 (PCL-6)
Measured: 8 weeks
Self-defined psychosocial problems (PSYCHLOPS)
Measured: 8 weeks
(Adapted) Client Service Receipt Inventory (CSRI)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start9 Dec 2019
- Primary completion16 Sep 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 1,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Ministry of Public Health, Lebanon, Freie Universität Berlin
- Responsible party
- Principal investigator, Pim Cuijpers, VU University of Amsterdam
- Investigators
- Pim Cuijpers, Professor, Principal investigator, VU Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720769
- Sponsor's protocol ID
- ERC.0002797
- Status last verified
- Apr 2021
- First submitted
- 24 Oct 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abi Ramia J, Khoury S, Armani N, Cuijpers P, Carswell K, van 't Hof E, Zoghbi E, Sijbrandij M, El Chammay R. From research to real-life implementation: an evaluation of the scale up of a guided digital mental health intervention in Lebanon: Step-by-Step. Front Public Health. 2025 Nov 11;13:1665093. doi: 10.3389/fpubh.2025.1665093. eCollection 2025.
PubMed 41306862Abi Hana R, Abi Ramia J, Burchert S, Carswell K, Cuijpers P, Heim E, Knaevelsrud C, Noun P, Sijbrandij M, van Ommeren M, Van't Hof E, Wijnen B, Zoghbi E, El Chammay R, Smit F. Cost-Effectiveness of Digital Mental Health Versus Usual Care During Humanitarian Crises in Lebanon: Pragmatic Randomized Trial. JMIR Ment Health. 2024 May 29;11:e55544. doi: 10.2196/55544.
PubMed 38810255Cuijpers P, Heim E, Abi Ramia J, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial. PLoS Med. 2022 Jun 23;19(6):e1004025. doi: 10.1371/journal.pmed.1004025. eCollection 2022 Jun.
PubMed 35737665Cuijpers P, Heim E, Ramia JA, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Guided digital health intervention for depression in Lebanon: randomised trial. Evid Based Ment Health. 2022 Dec;25(e1):e34-e40. doi: 10.1136/ebmental-2021-300416. Epub 2022 May 16.
PubMed 35577536van 't Hof E, Heim E, Abi Ramia J, Burchert S, Cornelisz I, Cuijpers P, El Chammay R, Harper Shehadeh M, Noun P, Smit F, van Klaveren C, van Ommeren M, Zoghbi E, Carswell K. Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials. JMIR Res Protoc. 2021 Jan 28;10(1):e21585. doi: 10.2196/21585.
PubMed 33507158
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention
- ClinicalTrials.gov ID
- NCT03720769
- Acronym / sponsor ID
- ERC.0002797
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- World Health Organization, Ministry of Public Health, Lebanon, Freie Universität Berlin
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 25 Oct 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 study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. First, a small study will be conducted to test the research procedure. Second, a large study will be conducted to test the effectiveness of Step-by-Step.
People residing in Lebanon (i.e. Lebanese, Palestinians and Syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. Minors (under the age of 18) and people who have plans to end their life will be excluded from the study.
To test whether the use of Step-by-Step improves symptoms of depression, two groups will be compared. Participants in the intervention group will receive Step-by-Step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. In addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. The study hypothesises that participants who receive Step-by-Step will have a higher symptom improvement than participants who receive basic information.
In order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: At the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step-by-Step | Experimental | Behavioral: Step-by-Step |
| Enhanced care as usual | Active comparator | Behavioral: Enhanced care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or above
- PHQ-9 sum score above 9
- WHODAS 2.0 sum score above 16
Key exclusion criteria (1 listed)
- Serious thoughts or plans to end one's life
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 |
|---|---|---|
| Step-by-StepGuided self-help programme delivered through an app/website for the treatment of depression | Behavioural | Step-by-Step |
| Enhanced care as usualPsychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres) | Behavioural | Enhanced care as usual |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 8 weeks
Self-administered instrument for depression screening (intention-to-treat analysis)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 8 weeks
Generic assessment instrument for health and disability (intention-to-treat analysis)
5 secondary outcomes
WHO-5 Well-Being Index
Time frame: 8 weeks
Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)
Time frame: 8 weeks
PTSD Checklist for DSM-5 (PCL-6)
Time frame: 8 weeks
Self-defined psychosocial problems (PSYCHLOPS)
Time frame: 8 weeks
(Adapted) Client Service Receipt Inventory (CSRI)
Time frame: 8 weeks
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 29 Apr 2021.
- Derived from this study: PubMed 41306862Abi Ramia J, Khoury S, Armani N, Cuijpers P, Carswell K, van 't Hof E, Zoghbi E, Sijbrandij M, El Chammay R. From research to real-life implementation: an evaluation of the scale up of a guided digital mental health intervention in Lebanon: Step-by-Step. Front Public Health. 2025 Nov 11;13:1665093. doi: 10.3389/fpubh.2025.1665093. eCollection 2025.
- Derived from this study: PubMed 38810255Abi Hana R, Abi Ramia J, Burchert S, Carswell K, Cuijpers P, Heim E, Knaevelsrud C, Noun P, Sijbrandij M, van Ommeren M, Van't Hof E, Wijnen B, Zoghbi E, El Chammay R, Smit F. Cost-Effectiveness of Digital Mental Health Versus Usual Care During Humanitarian Crises in Lebanon: Pragmatic Randomized Trial. JMIR Ment Health. 2024 May 29;11:e55544. doi: 10.2196/55544.
- Derived from this study: PubMed 35737665Cuijpers P, Heim E, Abi Ramia J, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial. PLoS Med. 2022 Jun 23;19(6):e1004025. doi: 10.1371/journal.pmed.1004025. eCollection 2022 Jun.
- Derived from this study: PubMed 35577536Cuijpers P, Heim E, Ramia JA, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Guided digital health intervention for depression in Lebanon: randomised trial. Evid Based Ment Health. 2022 Dec;25(e1):e34-e40. doi: 10.1136/ebmental-2021-300416. Epub 2022 May 16.
- Derived from this study: PubMed 33507158van 't Hof E, Heim E, Abi Ramia J, Burchert S, Cornelisz I, Cuijpers P, El Chammay R, Harper Shehadeh M, Noun P, Smit F, van Klaveren C, van Ommeren M, Zoghbi E, Carswell K. Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials. JMIR Res Protoc. 2021 Jan 28;10(1):e21585. doi: 10.2196/21585.
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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.
Pim Cuijpers, Professor principal investigator
VU Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step-by-Step and Enhanced care as usual in people with Depression, run by VU University of Amsterdam at 1 site in Lebanon.
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 3 inclusion and 1 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 29 Apr 2021. 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 Lebanon. 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?
Patient Health Questionnaire (PHQ-9) (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT03720769, which also lists 5 linked publications.
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 29 Apr 2021.