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Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients

Primary Purpose

Acceptance and Commitment Therapy, Psychotic Disorders, Psychiatric Nursing

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acceptance and Commitment Therapy focused on measuring Acceptance and Commitment Therapy, Early psychosis, Psychotic symptom, Functionality, Psychiatric Nursing, Early intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saglik Bilimleri UniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACT

Control

Arm Description

''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group.

Only data collection was carried out. No attempt was made by the researcher during the study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 13, 2022
Last Updated
January 31, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05210816
Brief Title
Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients
Official Title
The Effect of Acceptance and Commitment Therapy on Psychotic Symptoms and Functioning Levels in Early Psychosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acceptance and Commitment Therapy, Psychotic Disorders, Psychiatric Nursing
Keywords
Acceptance and Commitment Therapy, Early psychosis, Psychotic symptom, Functionality, Psychiatric Nursing, Early intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and control group
Masking
Participant
Masking Description
Experimental: Intervention group ''Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group Intervention: Behavioral: Acceptance and Commitment Therapy No Intervention: Control group Only data collection was carried out. No attempt was made by the researcher during the study.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACT
Arm Type
Experimental
Arm Description
''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only data collection was carried out. No attempt was made by the researcher during the study.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
9 month
Secondary Outcome Measure Information:
Title
Social Functioning Assessment Scale
Description
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.
Time Frame
9 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duygu ÖZER, MsN
Phone
+90 5061291978
Email
duyguozer2016@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melike DİŞSİZ, Assoc. Prof.
Phone
+90 5437995143
Email
melike.dişsiz@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu ÖZER, MsN
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saglik Bilimleri Universitesi
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duygu ÖZER, MsN
Phone
+90 5061291978
Email
duyguozer2016@hotmail.com
First Name & Middle Initial & Last Name & Degree
Melike Dişsiz, Assoc. Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients

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