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Testing e-Mental Health in Lebanon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720769
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
World Health Organization
Ministry of Public Health, Lebanon
Freie Universität Berlin
Information provided by (Responsible Party):
Pim Cuijpers, VU University of Amsterdam

Study Description
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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
Depression Behavioral: Step-by-Step Behavioral: Enhanced care as usual Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 9, 2019
Actual Primary Completion Date : September 16, 2020
Actual Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Client Satisfaction Questionnaire (CSQ-3) [ Time Frame: only at post-assessment (8 weeks after baseline) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720769


Locations
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Lebanon
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
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Principal Investigator: Pim Cuijpers, Professor VU Amsterdam
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pim Cuijpers, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT03720769    
Other Study ID Numbers: ERC.0002797
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms