Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Michigan | OTHER |
Not provided
Not provided
Not provided
Not provided
Multiple Sclerosis (MS) is a chronic autoimmune disease that affects the brain and spinal cord, often leading to unpredictable symptoms and significant emotional distress. Many people with MS experience anxiety, depression, and difficulties in coping with the challenges of the disease. Research has shown that effective coping-especially problem-focused coping-can reduce psychological distress and improve quality of life. However, access to psychological care can be limited, particularly in low-resource or mobility-restricted settings.This study, conducted at the Nehme and Therese Tohme Multiple Sclerosis Center at the American University of Beirut Medical Center (AUBMC), evaluated the feasibility and preliminary effectiveness of an eight-week, online psychological intervention designed to enhance problem-solving and coping strategies in adults with MS living in Lebanon.The primary objective was to determine whether an online problem-solving coping strategies (PCS) intervention is feasible, acceptable, and well-tolerated for people with MS. The secondary objective was to assess the intervention's preliminary effects on problem-focused coping, depression, and anxiety.
Design and Methods:This was a pilot randomized controlled trial (RCT) including 30 adults diagnosed with MS for at least one year. Participants were randomly assigned in equal numbers (1:1 ratio) to one of two groups:1. PCS Intervention group: 15 participants received eight weekly, 60-minute individual online sessions with a licensed clinical psychologist using WhatsApp video calls.2. Treatment-as-Usual (TAU) group: 15 participants continued their regular neurological and nursing care without additional psychological intervention.All participants completed questionnaires at baseline and at the end of the 8-week study to measure coping strategies, anxiety, and depression using validated Arabic versions of the Brief-COPE Scale and the Hopkins Symptom Checklist (HSCL-25). The PCS group also completed a self-developed Feasibility Questionnaire to assess the acceptability and practicality of the online sessions.Intervention Details:The PCS program was developed in Arabic by a multidisciplinary team including psychologists, nurses, and physicians. It was based on Lazarus and Folkman's Transactional Model of Stress and Coping (1984) and Problem-Solving Therapy principles. Each session included psychoeducation about healthy versus maladaptive coping, guided problem-solving exercises, and real-life applications through weekly homework. The sessions emphasized identifying challenges, generating solutions, weighing pros and cons, and implementing action plans
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm (PCS Intervention): Eight 60-minute online problem-solving coping sessions delivere | Experimental | 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. |
|
| Control Arm (Treatment As Usual): Standard neurological and nursing care, including routine medical | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-Solving Coping Strategies (PCS) Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Acceptability of the Online Problem-Solving Coping Strategies (PCS) Intervention | Feasibility and acceptability were evaluated using a self-developed Feasibility Questionnaire (score range: 13-65; higher scores indicate greater satisfaction and tolerance). | • 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Effectiveness of the Online Problem-Solving Coping Strategies (PCS) Intervention | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Beirut | 1107 2020 | Lebanon |
The investigators do not plan to share individual participant data (IPD) for this study. This decision is due to the small sample size (N=30) and the sensitive nature of psychological and clinical data collected from people with multiple sclerosis, which could increase the risk of indirect participant identification despite de-identification procedures. In addition, the study was conducted under institutional ethical approval at the American University of Beirut Medical Center, which restricts external data sharing for behavioral feasibility trials involving patient health information.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2024 | Mar 16, 2026 |
Not provided
This study used a randomized, parallel assignment model in which participants were randomly allocated (1:1) to one of two arms:
Intervention Arm: Participants received an 8-week, online Problem-Solving Coping Strategies (PCS) intervention delivered individually by a licensed clinical psychologist via WhatsApp video calls.
Control Arm: Participants received treatment as usual (TAU), consisting of standard neurological and nursing care provided at the AUBMC Multiple Sclerosis Center.
Each participant was assigned to only one study arm and followed for 8 weeks. No crossover occurred between groups. The model was chosen to compare the feasibility and preliminary effectiveness of the PCS intervention versus routine care in improving coping, anxiety, and depression among adults with multiple sclerosis.
Not provided
Not provided
Not provided
Not provided
|
| Treatment as usual (TAU) | Other | Standard neurological and nursing care, including regular medical follow-up, medication management, and rehabilitation or physical therapy as clinically indicated. No structured psychotherapy provided. |
|
| Assessments were completed at baseline and at 8 weeks following the intervention. • Change in Problem-Focused Coping (Brief-COPE subscale) baseline to 8 weeks |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided