NCT07586358

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Mental IllnessElectroconvulsive TherapyInternalised StigmaAnxietyPsychoeducationPsychiatric Nursing

Outcome Measures

Primary Outcomes (1)

  • Internalised Stigma Scale for Mental Illness (ISMI)

    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.

    Baseline and 6 weeks post-intervention

Secondary Outcomes (2)

  • State Anxiety Score (STAI-State)

    Baseline and 6 weeks post-intervention

  • Trait Anxiety Score (STAI-Trait)

    Baseline and 6 weeks post-intervention

Study Arms (2)

Psychoeducation Group (Arm 1)

EXPERIMENTAL

Participants received a structured psychoeducational programme in addition to routine psychiatric care.

Behavioral: Psychoeducational Programme

Routine Care Group (Arm 2)

ACTIVE COMPARATOR

Participants in this arm received routine psychiatric nursing care provided in the inpatient psychiatric clinic without any additional psychoeducational intervention.

Other: Routine Psychiatric Nursing Care

Interventions

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.

Psychoeducation Group (Arm 1)

Standard psychiatric nursing care provided during electroconvulsive therapy (ECT) treatment. No structured psychoeducational programme was applied.

Routine Care Group (Arm 2)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental DisordersAnxiety Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
No additional parties were masked beyond participants.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The type of research is a pre-test and post-test, control group randomised controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Phd(c)

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

August 20, 2025

Primary Completion

December 20, 2025

Study Completion

April 21, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations