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Completed

NCT Number: NCT07586358

Effect of Psychoeducation on Internalized Stigma and Anxiety in Patients Receiving Electroconvulsive Therapy

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.

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Key information

Conditions

Electroconvulsive Therapy (ECT) Anxiety Disorders Internalised Stigma Mental Disorders Mental Illnesses Psychiatric Nursing Psychoeducation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational Programme

Behavioral

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.

Routine Psychiatric Nursing Care

Other

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

Primary outcomes

  1. Internalised Stigma Scale for Mental Illness (ISMI)

    Time frame: Baseline and 6 weeks post-intervention

    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.

Secondary outcomes

  1. State Anxiety Score (STAI-State)

    Time frame: 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.

  2. Trait Anxiety Score (STAI-Trait)

    Time frame: Baseline and 6 weeks post-intervention

    Change in trait anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-Trait subscale. Higher scores indicate general anxiety tendency.

Sponsors and collaborators

Lead sponsor

Konya Necmettin Erbakan Üniversitesi

Other

Registry information

Official study title

THE EFFECT OF PSYCHOEDUCATION PROGRAM APPLIED TO PATIENTS RECEIVING ELECTROCONVULSIVE THERAPY ON PATIENTS' INTERNALIZED STIGMA AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY

Acronym: PE-ECT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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