NCT07507149

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 17, 2026

Last Update Submit

March 30, 2026

Conditions

Keywords

multiple sclerosisanxietyproblem -solving coping strategiesdepression

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Preliminary Effectiveness of the Online Problem-Solving Coping Strategies (PCS) Intervention

    Assessments were completed at baseline and at 8 weeks following the intervention. • Change in Problem-Focused Coping (Brief-COPE subscale) baseline to 8 weeks

Study Arms (2)

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.

Behavioral: Problem-Solving Coping Strategies (PCS) Intervention

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

Other: Treatment as usual (TAU)

Interventions

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

Experimental Arm (PCS Intervention): Eight 60-minute online problem-solving coping sessions delivere

Standard neurological and nursing care, including regular medical follow-up, medication management, and rehabilitation or physical therapy as clinically indicated. No structured psychotherapy provided.

Control Arm (Treatment As Usual): Standard neurological and nursing care, including routine medical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active suicidal ideation at screening
  • Cognitive impairment or psychiatric instability precluding participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, 1107 2020, Lebanon

Location

MeSH Terms

Conditions

Multiple SclerosisAnxiety DisordersDepression

Interventions

MethodsTherapeutics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, Department of Neurology, Director of Abu Haidar Neuroscience Institute and Multiple Sclerosis center at the American University of Beirut

Study Record Dates

First Submitted

February 17, 2026

First Posted

April 2, 2026

Study Start

July 1, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations