Multiple SclerosisNCT07507149
Evaluating the Feasibility and Effectiveness of an Online Psychological Intervention Targeting Problem-Solving and Coping Strategies in People With Multiple Sclerosis
A study testing Problem-Solving Coping Strategies (PCS) Intervention and Treatment as usual (TAU) in people with Multiple Sclerosis and Anxiety, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Anxiety, Problem Solving
- What is being tested?
- Problem-Solving Coping Strategies (PCS) Intervention and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active suicidal ideation at screening
- Cognitive impairment or psychiatric instability precluding participation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Being tested
- Problem-Solving Coping Strategies (PCS) Intervention, Treatment as usual (TAU)
- Keywords
- multiple sclerosis, anxiety, problem -solving coping strategies, depression
- Medical subject headings
- Multiple Sclerosis, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving Coping Strategies (PCS) InterventionBehavioural
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
Standard neurological and nursing care, including regular medical follow-up, medication management, and rehabilitation or physical therapy as clinically indicated. No structured psychotherapy provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: • 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
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).
Measured: Assessments were completed at baseline and at 8 weeks following the intervention. • Change in Problem-Focused Coping (Brief-COPE subscale) baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jul 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Samia Khoury, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507149
- Sponsor's protocol ID
- SBS-2023-0043
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Effectiveness of an Online Psychological Intervention Targeting Problem-Solving and Coping Strategies in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07507149
- Acronym / sponsor ID
- SBS-2023-0043
- Keywords
- multiple sclerosis, anxiety, problem -solving coping strategies, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (PCS Intervention): Eight 60-minute online problem-solving coping sessions delivere | Experimental | Behavioral: Problem-Solving Coping Strategies (PCS) InterventionParticipants 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 | Other: Treatment as usual (TAU)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Active suicidal ideation at screening
- Cognitive impairment or psychiatric instability precluding participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-Solving Coping Strategies (PCS) InterventionThis 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 | Behavioural | Experimental Arm (PCS Intervention): Eight 60-minute online problem-solving coping sessions delivere |
| Treatment as usual (TAU)Standard neurological and nursing care, including regular medical follow-up, medication management, and rehabilitation or physical therapy as clinically indicated. No structured psychotherapy provided. | Other | Control Arm (Treatment As Usual): Standard neurological and nursing care, including routine medical |
Primary outcome
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)
Feasibility and acceptability were evaluated using a self-developed Feasibility Questionnaire (score range: 13-65; higher scores indicate greater satisfaction and tolerance).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Coping Strategies (PCS) Intervention and Treatment as usual (TAU) in people with Multiple Sclerosis and Anxiety, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.