Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients

Psychotic Disorders Clinical Trial

Official title:

The Effect of Acceptance and Commitment Therapy on Psychotic Symptoms and Functioning Levels in Early Psychosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210816
• Other study ID #: SY200217B09
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2022
• Source: Saglik Bilimleri Universitesi
• Contact: Duygu ÖZER, MsN
• Phone: +90 5061291978
• Email: duyguozer2016[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to examine the effect of Acceptance and Commitment Therapy applied to patients in early psychosis patients on psychotic symptoms and functionality levels.

Description:

This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted at the Health Sciences University Sultan II. Abdulhamid Han Training and Research Hospital, Department of Psychiatry. According to the G-power analysis results, the minimum sample size of the study was calculated as 40 (intervention 20, control 20). Before randomization, the Personal Information Form and P1-P3 questions on the Positive and Negative Syndrome Scale (PANNS) will be applied to the patients in order to identify the patients with early psychosis. Computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control group without bias. It is planned that the intervention group will consist of at least 8 participants and the program will be implemented as three intervention groups. Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week. The control group will not receive any intervention by the researcher, and participants will continue with their routine treatment plan. The intervention groups after the program is completed and three months later, follow-up will be done by applying the post-test, while the control group will be followed-up by applying the post-test four weeks and three months later. In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilised studies in the literature and the basic ACT training she had received. After preparation of the ACT intervention protocol, it was given its final shape by obtaining the views of specialists working in this field. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The consent of himself/herself or his/she guardian to participate in the research,
• Being diagnosed with schizophrenia and other psychotic disorders for a minimum of six months and a maximum of three years according to DSM-V diagnostic criteria,
• Not to be in the acute attack period of the disease,
• The home environment is suitable for online conversation (computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.)
• Being between the ages of 18-65,
• Ability to read and write,
• There is no communication problem at a level that prevents the conversation,
• Absence of mental retardation, neurocognitive disorder, alcohol and substance abuse

Exclusion Criteria:

• Her/his is or her/his is guardian's refusal to participate in the research,
• Being diagnosed with schizophrenia and other psychotic disorders for less than six months or for more than three years, according to DSM-V diagnostic criteria,
• Being in the acute attack period of the disease,
• Not being able to read and write,
• Having a communication problem at a level that prevents the conversation,
• Having mental retardation, neurocognitive disorder, alcohol and substance addiction

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• Mental Disorders
• Psychiatric Nursing
• Psychotic Disorders

Intervention

Behavioral:
• Acceptance and Commitment Therapy
Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)	The PANNS scale provides an assessment of the severity of psychotic symptoms. Data is collected by the researcher through a semi-structured interview with the patients. In the scale consisting of 30 spiritual parameters; seven of them belong to the positive symptoms subscale, seven to the negative symptoms subscale, and the remaining sixteen to the general psychopathology subscale. The total score varies between 30-210. A total score of 58-74 from the scale is defined as mild, 75-94 points as moderate, 95-115 points as marked disease, and 116 and above points as severe disease.	9 month
Secondary	Social Functioning Assessment Scale	It is a 19-item Likert-type scale developed for schizophrenia patients. Each item is in the range of 1-3 points. It is seen that the scale consists of four factors as interpersonal relations and entertainment, self-care, independent living skills and working life. The score that can be obtained from the scale is in the range of 19-57, and a high score from the scale means that the individual has a high level of social functionality.	9 month