Testing e-Mental Health in Lebanon

Sponsor
VU University of Amsterdam (Other)
Overall Status
Completed
CT.gov ID
NCT03720769
Collaborator
World Health Organization (Other), Ministry of Public Health, Lebanon (Other), Freie Universität Berlin (Other)
1,248
1
2
12.4
100.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Step-by-Step
  • Behavioral: Enhanced care as usual
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention
Actual Study Start Date :
Dec 9, 2019
Actual Primary Completion Date :
Sep 16, 2020
Actual Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Step-by-Step

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

Active Comparator: Enhanced care as usual

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

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire (PHQ-9) [8 weeks]

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

  2. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [8 weeks]

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

Secondary Outcome Measures

  1. WHO-5 Well-Being Index [8 weeks]

  2. Generalized Anxiety Disorder - 7 Questionnaire (GAD-7) [8 weeks]

  3. PTSD Checklist for DSM-5 (PCL-6) [8 weeks]

  4. Self-defined psychosocial problems (PSYCHLOPS) [8 weeks]

  5. (Adapted) Client Service Receipt Inventory (CSRI) [8 weeks]

Other Outcome Measures

  1. Client Satisfaction Questionnaire (CSQ-3) [only at post-assessment (8 weeks after baseline)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 18 or above

  • PHQ-9 sum score above 9

  • WHODAS 2.0 sum score above 16

Exclusion Criteria:
  • Serious thoughts or plans to end one's life

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ministry of Public Health Beirut Lebanon

Sponsors and Collaborators

  • VU University of Amsterdam
  • World Health Organization
  • Ministry of Public Health, Lebanon
  • Freie Universität Berlin

Investigators

  • Principal Investigator: Pim Cuijpers, Professor, VU Amsterdam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pim Cuijpers, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT03720769
Other Study ID Numbers:
  • ERC.0002797
First Posted:
Oct 25, 2018
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2021