An interventional study of Group psychodrama in Multiple Sclerosis, Relapsing-Remitting, sponsored by Bahçeşehir University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Bahçeşehir University · Not applicable, Interventional, and Supportive care
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.
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's enrollment of 12 is below the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Bahçeşehir University is the lead sponsor of 128 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with relapsing-remitting MS attended 13 weekly group psychodrama sessions (approximately 180 minutes each) in addition to standard medical treatment.
Behavioral: Group psychodrama
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.
Also known as: Psychodrama group
Change in loneliness
Six-item UCLA Loneliness Scale short form (ULS-6); higher scores indicate greater loneliness.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Change in fatigue
21-item Modified Fatigue Impact Scale (MFIS), total and physical, cognitive and psychosocial subscale scores; higher scores indicate greater fatigue impact.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Change in information processing speed
Symbol Digit Modalities Test (SDMT); higher scores indicate better performance.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Change in verbal learning and memory
California Verbal Learning Test-Second Edition (CVLT-II); higher scores indicate better performance.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Change in depressive symptoms
17-item clinician-rated Hamilton Depression Rating Scale (HAM-D); higher scores indicate more severe depressive symptoms.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Change in anxiety symptoms
14-item clinician-rated Hamilton Anxiety Rating Scale (HAM-A); higher scores indicate more severe anxiety.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI) global score; higher scores indicate poorer sleep quality.
Time frame: Baseline, post-intervention (week 13) and 6-month follow-up
Participants' experiences of change
Individual semi-structured interviews exploring physical, cognitive, psychological and social changes, analysed with Colaizzi's descriptive phenomenological method.
Time frame: Post-intervention (week 13) and 6-month follow-up
Plan to share: Yes — De-identified individual participant data underlying the published results will be available from the principal investigator on reasonable request, subject to ethical approval and participant consent. Data are not publicly available because they contain sensitive health information from a small clinical sample in which participants could be identifiable.
Supporting information: Study protocol
Time frame: Following publication of the main results, for 5 years.
Access criteria: Requests from qualified researchers with a methodologically sound proposal should be sent to the principal investigator. Data will be shared after approval of the request and completion of a data-sharing agreement.
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Sep 2025, 9 months.
Of 79 non-industry interventional studies with no phase under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 45. This study's 9 months is below that.
Counting every sponsor, half of 81 studies reached it within 29 months; a quarter within 15 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Multiple Sclerosis, Relapsing-Remitting →