Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients

NCT ID: NCT05210816

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-09-30

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.

Conditions

Acceptance and Commitment Therapy; Psychotic Disorders; Psychiatric Nursing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ACT

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

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duygu ÖZER, MsN

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

Saglik Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ozer D, Dissiz M. The effect of online group based acceptance and commitment therapy on psychotic symptoms and functioning levels of individuals with early psychosis. Schizophr Res. 2024 May;267:55-64. doi: 10.1016/j.schres.2024.03.018. Epub 2024 Mar 22.

Reference Type: DERIVED

PMID: 38518479 (View on PubMed)

Other Identifiers

SY200217B09

Identifier Type: -

Identifier Source: org_study_id