Electroconvulsive Therapy (ECT)PE-ECTNCT07586358
Effect of Psychoeducation on Internalized Stigma and Anxiety in Patients Receiving Electroconvulsive Therapy
A study testing Psychoeducational Programme and Routine Psychiatric Nursing Care in people with Electroconvulsive Therapy (ECT) and Mental Illnesses, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electroconvulsive Therapy (ECT), Mental Illnesses, Internalised Stigma
- What is being tested?
- Psychoeducational Programme and Routine Psychiatric Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2025to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Electroconvulsive Therapy (ECT), Mental Illnesses, Internalised Stigma, Psychoeducation, Psychiatric Nursing
- Being tested
- Psychoeducational Programme, Routine Psychiatric Nursing Care
- Keywords
- Mental Illness, Electroconvulsive Therapy, Internalised Stigma, Anxiety, Psychoeducation, Psychiatric Nursing
- Medical subject headings
- Mental Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational ProgrammeBehavioural
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 CareOther
Standard psychiatric nursing care provided during electroconvulsive therapy (ECT) treatment. No structured psychoeducational programme was applied.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Group (Arm 1) | Experimental | Participants received a structured psychoeducational programme in addition to routine psychiatric care. Receives: 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. Receives: Other: Routine Psychiatric Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks post-intervention
Secondary outcomes (2)
State Anxiety Score (STAI-State)
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.
Measured: Baseline and 6 weeks post-intervention
Trait Anxiety Score (STAI-Trait)
Change in trait anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-Trait subscale. Higher scores indicate general anxiety tendency.
Measured: Baseline and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start20 Aug 2025
- Primary completion20 Dec 2025
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive Therapy (ECT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The type of research is a pre-test and post-test, control group randomised controlled experimental study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nur Filik, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586358
- Sponsor's protocol ID
- NEU-PhDHEM-2026-01
- Acronym
- PE-ECT
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PSYCHOEDUCATION PROGRAM APPLIED TO PATIENTS RECEIVING ELECTROCONVULSIVE THERAPY ON PATIENTS' INTERNALIZED STIGMA AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07586358
- Acronym / sponsor ID
- PE-ECT / NEU-PhDHEM-2026-01
- Conditions
- Electroconvulsive Therapy (ECT), Mental Illnesses, Internalised Stigma, Psychoeducation, Psychiatric Nursing
- Keywords
- Mental Illness, Electroconvulsive Therapy, Internalised Stigma, Anxiety, Psychoeducation, Psychiatric Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The type of research is a pre-test and post-test, control group randomised controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Group (Arm 1) | Experimental | Behavioral: Psychoeducational ProgrammeParticipants received a structured psychoeducational programme in addition to routine psychiatric care. |
| Routine Care Group (Arm 2) | Active comparator | Other: Routine Psychiatric Nursing CareParticipants in this arm received routine psychiatric nursing care provided in the inpatient psychiatric clinic without any additional psychoeducational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational ProgrammeA 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. | Behavioural | Psychoeducation Group (Arm 1) |
| Routine Psychiatric Nursing CareStandard psychiatric nursing care provided during electroconvulsive therapy (ECT) treatment. No structured psychoeducational programme was applied. | Other | Routine Care Group (Arm 2) |
Primary outcome
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.
2 secondary outcomes
State Anxiety Score (STAI-State)
Time frame: Baseline and 6 weeks post-intervention
Trait Anxiety Score (STAI-Trait)
Time frame: Baseline and 6 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Programme and Routine Psychiatric Nursing Care in people with Electroconvulsive Therapy (ECT) and Mental Illnesses, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalised Stigma Scale for Mental Illness (ISMI) (time frame: Baseline and 6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.