- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507149
Evaluating the Feasibility and Effectiveness of an Online Psychological Intervention Targeting Problem-Solving and Coping Strategies in People With Multiple Sclerosis
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beirut, Lebanon, 1107 2020
- American University of Beirut
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Diagnosis of Multiple Sclerosis ≥ 1 year (McDonald criteria 2017)
- Access to a stable internet connection and smartphone/laptop
- Able to provide informed consent
Exclusion Criteria:
- Active suicidal ideation at screening
- Cognitive impairment or psychiatric instability precluding participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Arm (PCS Intervention): Eight 60-minute online problem-solving coping sessions delivere
Participants in the experimental arm received an eight-week online psychological intervention designed to strengthen problem-solving and adaptive coping skills.
Each participant attended eight individual 60-minute sessions conducted weekly via WhatsApp video calls with a licensed clinical psychologist trained in multiple sclerosis (MS) care.
The sessions followed a structured behavioral therapy framework emphasizing awareness of stress triggers, generation of practical solutions, and emotional regulation strategies.
Participants were encouraged to apply techniques between sessions and review progress with the psychologist.
The program aimed to improve coping, reduce depression and anxiety, and enhance emotional well-being in people living with MS.
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This intervention is unique in that it delivers a structured, psychologist-guided problem-solving and coping program entirely via WhatsApp video calls, a widely accessible and low-cost platform in Lebanon and the MENA region. Unlike most telehealth or cognitive-behavioral interventions that rely on specialized software, this program was developed in Arabic and culturally adapted for adults with multiple sclerosis (MS) to address psychosocial stress, depression, and anxiety within local contexts. The content integrates Lazarus and Folkman's Transactional Model of Stress and Coping with Problem-Solving Therapy (PST) principles, emphasizing practical, real-life coping skills rather than symptom education alone. Delivered individually by a licensed clinical psychologist trained in MS-specific behavioral care, the program also includes weekly skill practice, personalized feedback, and a coping diary, making it a tailored, behaviorally focused, and patient-centered telepsychology model disti |
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Other: Control Arm (Treatment As Usual): Standard neurological and nursing care, including routine medical
Participants assigned to the control group received standard medical and nursing care as routinely provided at the Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center.
Care included regular neurological follow-up, medication management, and access to rehabilitation or physical therapy when clinically indicated.
Participants did not receive any structured psychological or behavioral intervention during the study period.
To parallel assessment frequency, they completed the same baseline and 8-week outcome evaluations as the intervention group, including measures of coping, depression, and anxiety.
This arm represents standard multidisciplinary MS care without additional psychotherapy or coping skills training
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Standard neurological and nursing care, including regular medical follow-up, medication management, and rehabilitation or physical therapy as clinically indicated.
No structured psychotherapy provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility and Acceptability of the Online Problem-Solving Coping Strategies (PCS) Intervention
Time Frame: • Recruitment rate (% of eligible patients enrolled) - 4 months • Retention and session adherence (completion of ≥6/8 sessions) - 8 weeks • Participant satisfaction using the Feasibility Questionnaire (score range: 13-65; 8weeks)
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Feasibility and acceptability were evaluated using a self-developed Feasibility Questionnaire (score range: 13-65; higher scores indicate greater satisfaction and tolerance).
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• Recruitment rate (% of eligible patients enrolled) - 4 months • Retention and session adherence (completion of ≥6/8 sessions) - 8 weeks • Participant satisfaction using the Feasibility Questionnaire (score range: 13-65; 8weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preliminary Effectiveness of the Online Problem-Solving Coping Strategies (PCS) Intervention
Time Frame: Assessments were completed at baseline and at 8 weeks following the intervention. • Change in Problem-Focused Coping (Brief-COPE subscale) baseline to 8 weeks
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Preliminary Effectiveness of the Online Problem-Solving Coping Strategies (PCS) Intervention Effectiveness was assessed by comparing pre- and post-intervention coping changes between PCS and Treatment-as-Usual (TAU) groups.
Problem-focused coping was measured using the Brief COPE Scale (scores 8-32; higher scores indicate greater use of problem-focused strategies).
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Assessments were completed at baseline and at 8 weeks following the intervention. • Change in Problem-Focused Coping (Brief-COPE subscale) baseline to 8 weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Autoimmune Diseases
- Immune System Diseases
- Behavioral Symptoms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Behavior
- Anxiety Disorders
- Multiple Sclerosis
- Depression
- Investigative Techniques
- Methods
- Therapeutics
Other Study ID Numbers
- SBS-2023-0043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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