- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07586358
Effect of Psychoeducation on Internalized Stigma and Anxiety in Patients Receiving Electroconvulsive Therapy (PE-ECT)
THE EFFECT OF PSYCHOEDUCATION PROGRAM APPLIED TO PATIENTS RECEIVING ELECTROCONVULSIVE THERAPY ON PATIENTS' INTERNALIZED STIGMA AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
This randomized controlled clinical trial was conducted to evaluate the effect of a psychoeducational programme on internalised stigma and anxiety levels in patients undergoing electroconvulsive therapy (ECT). The study aimed to determine whether the psychoeducational intervention reduces internalised stigma related to mental illness and improves anxiety outcomes compared to routine nursing care.
The primary questions addressed were:
Does the psychoeducational programme reduce internalised stigma in patients receiving ECT? Does the intervention decrease state and trait anxiety levels compared to routine care? Researchers compared a psychoeducational intervention group with a control group receiving routine nursing care to assess the effects of the programme on psychological outcomes.
Participants in the intervention group:
Received a six-session psychoeducational programme delivered individually over six weeks Completed pre-test and post-test assessments using standardized measurement tools
Participants in the control group received routine psychiatric nursing care and completed the same assessment measures at equivalent time points.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Meram
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Konya, Meram, Tyrkiet (Türkiye)
- Necmettin Erbakan University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Able to read and write in Turkish
- At least primary school graduate
- Diagnosed according to DSM-5 criteria with schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, obsessive-compulsive disorder, or generalized anxiety disorder
- Inpatients in a psychiatric clinic
- Receiving or scheduled to receive electroconvulsive therapy (ECT)
- No severe agitation or homicidal risk as determined by the treating psychiatrist
- Voluntary consent to participate in the study
Exclusion Criteria:
- Diagnosis of organic mental disorders (e.g., dementia, Alzheimer's disease, delirium)
- Intellectual disability
- History of alcohol or substance dependence
- Not completing at least 4 ECT sessions during the treatment process
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Psychoeducation Group (Arm 1)
Participants received a structured psychoeducational programme in addition to routine psychiatric care.
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A structured psychoeducational programme consisting of six individual face-to-face sessions delivered over six weeks by the researcher.
The programme aimed to reduce internalised stigma and anxiety in patients undergoing electroconvulsive therapy (ECT) and included education about illness, treatment process, coping strategies, and emotional support.
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Aktiv komparator: Routine Care Group (Arm 2)
Participants in this arm received routine psychiatric nursing care provided in the inpatient psychiatric clinic without any additional psychoeducational intervention.
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Standard psychiatric nursing care provided during electroconvulsive therapy (ECT) treatment.
No structured psychoeducational programme was applied.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Internalised Stigma Scale for Mental Illness (ISMI)
Tidsramme: Baseline and 6 weeks post-intervention
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Change in internalized stigma levels in patients undergoing electroconvulsive therapy (ECT), measured using the Internalized Stigma of Mental Illness Scale (ISMI).
Higher scores indicate higher levels of internalized stigma.
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Baseline and 6 weeks post-intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
State Anxiety Score (STAI-State)
Tidsramme: Baseline and 6 weeks post-intervention
|
Change in state anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-State subscale.
Higher scores indicate higher levels of current anxiety.
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Baseline and 6 weeks post-intervention
|
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Trait Anxiety Score (STAI-Trait)
Tidsramme: Baseline and 6 weeks post-intervention
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Change in trait anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-Trait subscale.
Higher scores indicate general anxiety tendency.
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Baseline and 6 weeks post-intervention
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NEU-PhDHEM-2026-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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