CompletedNCT07928765ClinicalTrials.gov record

Psychodrama for Adults With Relapsing-Remitting Multiple Sclerosis: A Mixed-Methods Study

Multiple Sclerosis, Relapsing-Remitting

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 65 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 12 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This single-group, mixed-methods study explored changes following a 13-week group psychodrama programme in adults with relapsing-remitting multiple sclerosis (MS). Participants were recruited from the demyelinating diseases unit of Mersin University Hospital, Türkiye, and attended weekly sessions of approximately 180 minutes in addition to their standard medical treatment. Loneliness, fatigue, cognitive performance, depressive and anxiety symptoms, and sleep quality were assessed at baseline, after the intervention and at 6-month follow-up. Individual semi-structured interviews conducted after the intervention and at follow-up explored participants' experiences of physical, cognitive, psychological and social change. Quantitative and qualitative findings were integrated within a convergent mixed-methods design.

Read the full description

Background: People with MS frequently experience fatigue, cognitive difficulties, depressive and anxiety symptoms, sleep problems and loneliness. Psychodrama is an action-based group psychotherapy method that may support emotional expression, role flexibility and interpersonal connection, but evidence in MS is limited.

Design: Exploratory convergent mixed-methods study combining a one-group pretest-posttest-follow-up quantitative component with a descriptive phenomenological qualitative component. Both components were given equal priority, analysed separately and then integrated using a joint display.

Intervention: A closed psychodrama group met once weekly for 13 sessions (12 December 2024 to 6 March 2025). Each session lasted approximately 180 minutes and followed the classical structure of warm-up, action and sharing, using techniques such as doubling, role reversal, mirroring, soliloquy, chorus and sociometry. Sessions were facilitated by a psychiatric nurse (PhD) with psychodrama assistant certification and a clinical psychologist with psychodrama training. Two trainer psychodramatists provided supervision before and after each session. Neurology clinicians supported medical follow-up, and a referral pathway to neurology and psychiatric services was in place.

Assessments: Loneliness (UCLA Loneliness Scale short form, ULS-6), fatigue (Modified Fatigue Impact Scale, MFIS), cognitive performance (Symbol Digit Modalities Test, SDMT; California Verbal Learning Test-II, CVLT-II), depressive symptoms (Hamilton Depression Rating Scale, HAM-D), anxiety symptoms (Hamilton Anxiety Rating Scale, HAM-A) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) were assessed at baseline, post-intervention and 6-month follow-up. Individual online semi-structured interviews were conducted at post-intervention and follow-up.

Analysis: Quantitative data were analysed with the Friedman test and pairwise Wilcoxon signed-rank tests in IBM SPSS Statistics. Qualitative data were analysed with Colaizzi's descriptive phenomenological method in MAXQDA by two independent coders. This study was registered retrospectively.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Diagnosis of relapsing-remitting multiple sclerosis, in remission
Age 18 to 65 years
Willingness to attend group sessions regularly
Written informed consent

Exclusion Criteria:

Wheelchair dependence
Acute psychiatric disorder
Hearing or speech impairment that would prevent group participation

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Psychodrama group

Adults with relapsing-remitting MS attended 13 weekly group psychodrama sessions (approximately 180 minutes each) in addition to standard medical treatment.

Behavioral: Group psychodrama

Group psychodrama BEHAVIORAL

Closed-group psychodrama delivered once weekly for 13 sessions of approximately 180 minutes. Each session followed the warm-up, action and sharing structure and included group-centred exercises, protagonist work and vignettes using doubling, role reversal, mirroring, soliloquy, chorus and sociometry. The programme was shaped flexibly according to needs emerging in the group process rather than a symptom-focused protocol.

Prepare your questions