Clinical trial NCT05210816: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acceptance and Commitment Therapy
Psychotic Disorders
Psychiatric Nursing
Keywords: Acceptance and Commitment Therapy
Early psychosis
Psychotic symptom
Functionality
Psychiatric Nursing
Early intervention
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 9 month
Secondary outcomes:
measure: Social Functioning Assessment Scale
timeFrame: 9 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Duygu ÖZER, MsN
role: PRINCIPAL_INVESTIGATOR
References: