NCT05662137

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable schizophrenia

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

First Submitted

Initial submission to the registry

December 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

December 14, 2022

Last Update Submit

October 29, 2023

Conditions

Keywords

AlexithymiaSchizophreniaEmotion, Expressed

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    One day

Study Arms (2)

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.

Behavioral: Emotions Recognition and Expression

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop Community Mental Health Center

Sinop, 57000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SchizophreniaAffective Symptoms

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Adeviye AYDIN, PhD

    Sinop University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 22, 2022

Study Start

January 15, 2023

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations