NCT03720769

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,248

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

October 24, 2018

Last Update Submit

April 28, 2021

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire (PHQ-9)

    Self-administered instrument for depression screening (intention-to-treat analysis)

    8 weeks

  • WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Generic assessment instrument for health and disability (intention-to-treat analysis)

    8 weeks

Secondary Outcomes (5)

  • WHO-5 Well-Being Index

    8 weeks

  • Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)

    8 weeks

  • PTSD Checklist for DSM-5 (PCL-6)

    8 weeks

  • Self-defined psychosocial problems (PSYCHLOPS)

    8 weeks

  • (Adapted) Client Service Receipt Inventory (CSRI)

    8 weeks

Other Outcomes (1)

  • Client Satisfaction Questionnaire (CSQ-3)

    only at post-assessment (8 weeks after baseline)

Study Arms (2)

Step-by-Step

EXPERIMENTAL
Behavioral: Step-by-Step

Enhanced care as usual

ACTIVE COMPARATOR
Behavioral: Enhanced care as usual

Interventions

Step-by-StepBEHAVIORAL

Guided self-help programme delivered through an app/website for the treatment of depression

Step-by-Step
Enhanced care as usualBEHAVIORAL

Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)

Enhanced care as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or above
  • PHQ-9 sum score above 9
  • WHODAS 2.0 sum score above 16

You may not qualify if:

  • Serious thoughts or plans to end one's life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Public Health

Beirut, Lebanon

Location

Related Publications (5)

  • 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.

    PMID: 41306862DERIVED

  • Abi 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.

    PMID: 38810255DERIVED

  • Cuijpers 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.

    PMID: 35737665DERIVED

  • Cuijpers 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.

    PMID: 35577536DERIVED

  • van '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.

    PMID: 33507158DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Pim Cuijpers, Professor

    VU Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

December 9, 2019

Primary Completion

September 16, 2020

Study Completion

December 20, 2020

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

LE(1)