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Completed

NCT Number: NCT03720769

Testing e-Mental Health in Lebanon

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Public Health

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step-by-step

Behavioral

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

Enhanced Care as Usual

Behavioral

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

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 8 weeks

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

  2. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: 8 weeks

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

Secondary outcomes

  1. WHO-5 Well-Being Index

    Time frame: 8 weeks

  2. Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)

    Time frame: 8 weeks

  3. PTSD Checklist for DSM-5 (PCL-6)

    Time frame: 8 weeks

  4. Self-defined psychosocial problems (PSYCHLOPS)

    Time frame: 8 weeks

  5. (Adapted) Client Service Receipt Inventory (CSRI)

    Time frame: 8 weeks

Other outcomes

  1. Client Satisfaction Questionnaire (CSQ-3)

    Time frame: only at post-assessment (8 weeks after baseline)

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Collaborators

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

Registry information

Official study title

Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2018
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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