NCT05210816

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 7, 2024

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 13, 2022

Last Update Submit

June 6, 2024

Conditions

Keywords

Acceptance and Commitment TherapyEarly psychosisPsychotic symptomFunctionalityPsychiatric NursingEarly intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Social Functioning Assessment Scale

    9 month

Study Arms (2)

ACT

EXPERIMENTAL

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

Behavioral: Acceptance and Commitment Therapy

Control

NO INTERVENTION

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

Interventions

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.

ACT

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Duygu ÖZER, MsN

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 27, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

June 7, 2024

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations