SchizophreniaNCT05662137
The Effect of Recognition and Expression of Emotions Program Applied to Schizophrenia Patients
A study testing Emotions Recognition and Expression in people with Schizophrenia and Alexithymia, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
As a result of the positive and negative symptoms that occur in schizophrenia, patients with schizophrenia may experience negative emotions more frequently than individuals with other mental problems. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Schizophrenia, Alexithymia, Emotion, Expressed
- What is being tested?
- Emotions Recognition and Expression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 May 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who had received a diagnosis of schizophrenia and comes to the Community Mental Health Center regularly,
- Being able to read and communicate
- Being 18 years of age or older,
- Not having mental retardation,
- Not having insight, understanding, hearing problems,
- Being in remission,
- Volunteering to study
Who cannot join
- Not diagnosed with clinical schizophrenia,
- Being under the age of 18,
- Having mental retardation,
- Having no insight,
- Not understanding and hearing,
- Not in remission
- Refusing to participate in the study
- Stop studying at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sinop Community Mental Health Center
Sinop, 57000
About this study
Official title: The Effect of Recognition and Expression of Emotions Program Applied to Schizophrenia Patients Applying to Community Mental Health Center on Alexithymia and Emotion Expression
As a result of the positive and negative symptoms that occur in schizophrenia, patients with schizophrenia may experience negative emotions more frequently than individuals with other mental problems. Since these emotions can trigger psychotic symptoms, there is a need to develop effective emotion regulation strategies to be applied to patients with schizophrenia.
Aim: In this study, it was aimed to examine the effect of emotion recognition and expression program on alexithymia and emotion expression in patients with schizophrenia.
Read the detailed description
Method: Fifty schizophrenic patients who regularly receive outpatient treatment at Sinop Community Mental Health Center will form the universe of the study. Individuals over the age of 18 who have schizophrenia, do not have mental retardation, have no comprehension and hearing problems, have insight, and are in remission will be included in the study. Individuals who meet the study criteria will be divided into experimental and control groups as 22 experimental and 22 control groups. The emotion recognition and expression program prepared by the researchers in line with the literature will be applied to the experimental group for 8 weeks. Personal Information Form, Expression of Emotions Scale, Positive and Negative Syndrome Scale and Toronto Alexithymia Scale were planned to be applied to the experimental and control groups in the pre-test, post-test and follow-up. Follow-up will take place one month after the last session of the study. Psychosocial interventions applied to patients with schizophrenia help patients to increase their level of well-being and quality of life, to decrease negative and positive symptoms by increasing social functionality, to participate in social life, to be an autonomous individual and to prevent stigma. In line with psychosocial interventions, it is thought that the this program to be applied to the patients in this study will basically contribute to the individual patients' ability to recognize their emotions, discuss their emotions, regulate their emotion intensities, and express their emotions. Due to the impact that this program will have on the individual, it is believed that it will have positive results not only for schizophrenia patients, but also for the individuals with whom the patients interact, their relatives and even the society.
- Conditions
- Schizophrenia, Alexithymia, Emotion, Expressed
- Being tested
- Emotions Recognition and Expression
- Keywords
- Alexithymia, Schizophrenia, Emotion, Expressed
- Medical subject headings
- Schizophrenia, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotions Recognition and ExpressionBehavioural
Emotion recognition and expression program consisting of 8 sessions will be used. In this program, patients will have the opportunity to describe their emotions, explain emotions that are difficult to express such as anger, sadness, shame, guilt, and discuss the consequences of suppressed emotions.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | At the beginning of the study, data collection tools Personal Information Form, Expression of Emotions Scale, Toronto Alexithymia Scale, Positive and Negative Syndrome Scale will be applied to the control group. No intervention will be made in the control group. Measurement tools will be applied for the posttest. Emotional Expression Scale, Toronto Alexithymia Scale and Positive and Negative Syndrome Scale will be reapplied 1 month after the last session. |
| Experimental group | Experimental | Emotion recognition and expression program is aimed to be carried out in 8-week sessions for schizophrenia patients included in the experimental group. Personal Information Form, Expression of Emotions Scale, Toronto Alexithymia Scale, Positive and Negative Syndrome Scale will be applied to the experiment. The principal investigator will lead the structured group sessions as the group leader.
The principal investigator will lead the structured group sessions as the group leader.
Each group is planned to be 60-90 minutes. Before sessions, participants are taken from their previous session's emotions so far. Homework is discussed by providing recall of the topic from the previous session, and then the current topic is moved on. At the end of each session, a general summary and evaluation is made. After the sessions in the research, measurement tools will be applied for the posttest. It will be reapplied 1 month after the last session. Receives: Behavioral: Emotions Recognition and Expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Recognition and Expression
Expression of Emotions Scale is used to measure the state of expression of emotions. The scale was developed by King and Emmons (1990), and its Turkish validity and reliability were verified by Kuzucu (2011). The measurement tool consists of a total of 16 items and 3 sub-dimensions. It has positive, negative and closeness sub-dimensions. It is a 7-point Likert type scale .The scores to be taken from the scale vary between 15 and 105, and as the scores obtained increase, it is seen that the tendency of the individual to express emotion increases. The scale provides information about expressing emotions both in interpersonal relationships and independent of interpersonal relationships. A high score indicates a high tendency to express emotions.
Measured: One day
Alexithymia
Toronto Alexithymia Scale (TAS): The scale was developed by Bagby et al. (1994) Güleç et al. (2009) adapted into Turkish. The scale consists of 20 items, has three sub-dimensions and is in a 5-point Likert type. High scores indicate high alexithymic level. There are sub-dimensions of difficulty in recognizing emotions, difficulty in putting emotions into words, and extroverted thinking.
Measured: One day
Positive and Negative Syndrome
Positive and Negative Syndrome Scale (PANNS): The scale evaluating positive and negative symptoms in schizophrenia was developed by Kay et al (1987) and Kostakoğlu et al. It was adapted into Turkish by (1999). Consisting of 30 items, the scale has three sub-dimensions. A 7-point severity assessment is carried out. Seven of the items of the scale belong to the positive symptoms subscale, seven to the negative symptoms subscale, and the remaining sixteen to the general psychopathology subscale.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Jan 2023
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeviye AYDIN, PhD, Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662137
- Sponsor's protocol ID
- sınopUadeviye-1
- Status last verified
- Oct 2023
- First submitted
- 14 Dec 2022
- Last updated
- 31 Oct 2023
- 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Recognition and Expression of Emotions Program Applied to Schizophrenia Patients Applying to Community Mental Health Center on Alexithymia and Emotion Expression
- ClinicalTrials.gov ID
- NCT05662137
- Acronym / sponsor ID
- sınopUadeviye-1
- Conditions
- Schizophrenia, Alexithymia, Emotion, Expressed
- Keywords
- Alexithymia, Schizophrenia, Emotion, Expressed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 22 Dec 2022 (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.
As a result of the positive and negative symptoms that occur in schizophrenia, patients with schizophrenia may experience negative emotions more frequently than individuals with other mental problems. Since these emotions can trigger psychotic symptoms, there is a need to develop effective emotion regulation strategies to be applied to patients with schizophrenia.
Aim: In this study, it was aimed to examine the effect of emotion recognition and expression program on alexithymia and emotion expression in patients with schizophrenia.
Detailed description
Method: Fifty schizophrenic patients who regularly receive outpatient treatment at Sinop Community Mental Health Center will form the universe of the study. Individuals over the age of 18 who have schizophrenia, do not have mental retardation, have no comprehension and hearing problems, have insight, and are in remission will be included in the study. Individuals who meet the study criteria will be divided into experimental and control groups as 22 experimental and 22 control groups. The emotion recognition and expression program prepared by the researchers in line with the literature will be applied to the experimental group for 8 weeks. Personal Information Form, Expression of Emotions Scale, Positive and Negative Syndrome Scale and Toronto Alexithymia Scale were planned to be applied to the experimental and control groups in the pre-test, post-test and follow-up. Follow-up will take place one month after the last session of the study. Psychosocial interventions applied to patients with schizophrenia help patients to increase their level of well-being and quality of life, to decrease negative and positive symptoms by increasing social functionality, to participate in social life, to be an autonomous individual and to prevent stigma. In line with psychosocial interventions, it is thought that the this program to be applied to the patients in this study will basically contribute to the individual patients' ability to recognize their emotions, discuss their emotions, regulate their emotion intensities, and express their emotions. Due to the impact that this program will have on the individual, it is believed that it will have positive results not only for schizophrenia patients, but also for the individuals with whom the patients interact, their relatives and even the society.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –At the beginning of the study, data collection tools Personal Information Form, Expression of Emotions Scale, Toronto Alexithymia Scale, Positive and Negative Syndrome Scale will be applied to the control group. No intervention will be made in the control group. Measurement tools will be applied for the posttest. Emotional Expression Scale, Toronto Alexithymia Scale and Positive and Negative Syndrome Scale will be reapplied 1 month after the last session. |
| Experimental group | Experimental | Behavioral: Emotions Recognition and ExpressionEmotion recognition and expression program is aimed to be carried out in 8-week sessions for schizophrenia patients included in the experimental group. Personal Information Form, Expression of Emotions Scale, Toronto Alexithymia Scale, Positive and Negative Syndrome Scale will be applied to the experiment. The principal investigator will lead the structured group sessions as the group leader. The principal investigator will lead the structured group sessions as the group leader. Each group is planned to be 60-90 minutes. Before sessions, participants are taken from their previous session's emotions so far. Homework is discussed by providing recall of the topic from the previous session, and then the current topic is moved on. At the end of each session, a general summary and evaluation is made. After the sessions in the research, measurement tools will be applied for the posttest. It will be reapplied 1 month after the last session. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient who had received a diagnosis of schizophrenia and comes to the Community Mental Health Center regularly,
- Being able to read and communicate
- Being 18 years of age or older,
- Not having mental retardation,
- Not having insight, understanding, hearing problems,
Key exclusion criteria (8 listed)
- Not diagnosed with clinical schizophrenia,
- Being under the age of 18,
- Having mental retardation,
- Having no insight,
- Not understanding and hearing,
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 |
|---|---|---|
| Emotions Recognition and ExpressionEmotion recognition and expression program consisting of 8 sessions will be used. In this program, patients will have the opportunity to describe their emotions, explain emotions that are difficult to express such as anger, sadness, shame, guilt, and discuss the consequences of suppressed emotions. | Behavioural | Experimental group |
Primary outcome
Emotion Recognition and Expression
Time frame: One day
Expression of Emotions Scale is used to measure the state of expression of emotions. The scale was developed by King and Emmons (1990), and its Turkish validity and reliability were verified by Kuzucu (2011). The measurement tool consists of a total of 16 items and 3 sub-dimensions. It has positive, negative and closeness sub-dimensions. It is a 7-point Likert type scale .The scores to be taken from the scale vary between 15 and 105, and as the scores obtained increase, it is seen that the tendency of the individual to express emotion increases. The scale provides information about expressing emotions both in interpersonal relationships and independent of interpersonal relationships. A high score indicates a high tendency to express emotions.
Alexithymia
Time frame: One day
Toronto Alexithymia Scale (TAS): The scale was developed by Bagby et al. (1994) Güleç et al. (2009) adapted into Turkish. The scale consists of 20 items, has three sub-dimensions and is in a 5-point Likert type. High scores indicate high alexithymic level. There are sub-dimensions of difficulty in recognizing emotions, difficulty in putting emotions into words, and extroverted thinking.
Positive and Negative Syndrome
Time frame: One day
Positive and Negative Syndrome Scale (PANNS): The scale evaluating positive and negative symptoms in schizophrenia was developed by Kay et al (1987) and Kostakoğlu et al. It was adapted into Turkish by (1999). Consisting of 30 items, the scale has three sub-dimensions. A 7-point severity assessment is carried out. Seven of the items of the scale belong to the positive symptoms subscale, seven to the negative symptoms subscale, and the remaining sixteen to the general psychopathology subscale.
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 31 Oct 2023.
- 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.
Adeviye AYDIN, PhD principal investigator
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotions Recognition and Expression in people with Schizophrenia and Alexithymia, run by Sinop University 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 7 inclusion and 8 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 31 Oct 2023. 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?
Emotion Recognition and Expression (time frame: One day). The study lists 3 primary outcomes in all. 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 31 Oct 2023.