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Trial record 45 of 237 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Testing e-Mental Health in Lebanon

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ClinicalTrials.gov Identifier: NCT03720769
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborators:
World Health Organization
Ministry of Public Health, Lebanon
Freie Universität Berlin
Information provided by (Responsible Party):
Pim Cuijpers, VU University of Amsterdam

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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)




Primary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: 20 weeks ]
    self-administered instrument for depression screening

  2. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 20 weeks ]
    generic assessment instrument for health and disability


Secondary Outcome Measures :
  1. WHO-5 Well-Being Index [ Time Frame: 20 weeks ]
  2. Generalized Anxiety Disorder - 7 Questionnaire (GAD-7) [ Time Frame: 20 weeks ]
  3. PTSD Checklist for DSM-5 (PCL-6) [ Time Frame: 20 weeks ]
  4. Self-defined psychosocial problems (PSYCHLOPS) [ Time Frame: 20 weeks ]
  5. (Adapted) Client Service Receipt Inventory (CSRI) [ Time Frame: 20 weeks ]

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


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

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


Contacts
Contact: Jinane Abi Ramia, MSc +961 3 543 902 Jinane.abiramia@gmail.com

Locations
Lebanon
Ministry of Public Health Recruiting
Beirut, Lebanon
Contact: Jinane Abi Ramia, MSc    +961 3 543 902    Jinane.abiramia@gmail.com   
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

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No