Effect of Acceptance and Commitment Therapy on Psychotic Severity

Psychosis Clinical Trial

Official title:

Efficacy of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychosis: A Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06160869
• Other study ID #: P.0553
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: October 2023
• Source: Port Said University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our study aims to assess the efficacy of Acceptance and Commitment Therapy on psychotic severity among Inpatients with primary psychosis: A Randomized Controlled Trial.

Description:

Current study was an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of Acceptance and Commitment Therapy (ACT) added to treatment as usual (TAU) as opposed to treatment as usual (TAU) alone on patients with schizophrenia. The study adheres to the rules for writing Clinical Trials: "The Consolidated Standards of Reporting Trials" (CONSORT) statement

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 20, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria Participants' criteria of inclusion involved those patients who were

1. Current psychiatric hospitalization;

2. DSM-5 diagnosis of a primary psychotic disorder; (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder, brief psychotic disorder, and unspeci?ed psychotic disorder, this diagnosis was confirmed by a psychiatrist

3. 18 years or older;

4. ability to talk, read and write in Arabic; and

5. willingness to participate in the study that was scheduled for seven weeks. Exclusion criteria Patients were excluded if they

1. had a comorbid learning disability or organic brain disorder;

2. psychosis related to a general medical condition or substance-induced psychotic disorder;

3. were considered mentally unstable; or

4. unfit to participate in the study by their therapist, and/or had newly had (been receiving) psycho-education or somewhat designed psychosocial intervention.

Related Conditions & MeSH terms

• Emotion Regulation
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Recovery

Intervention

Behavioral:
• Acceptance and commitment therapy
The psychoeducational intervention will consist of seven structured sessions aimed at introducing patients with primary psychosis to the principles and practices of Acceptance and Commitment Therapy (ACT). The primary focus of the intervention is to empower participants to effectively manage distressing thoughts and feelings while pursuing meaningful and valued life goals. Each session covers specific aspects of ACT. Acceptance and commitment therapy will be adminitered in addition to treament as usual provided to patients.

Combination Product:
• Treatment as usual
The treatment as usual (TAU) for all patients regardless of condition will consist of hospital treatment, including daily medication management sessions with a psychiatrist (e.g., antipsychotic and other medications as appropriate), community meetings, other group therapy, case management, occupational therapy, open air walks, discharge planning, physical examination, and other services (e.g., medical testing).

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Port Said University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)	Measuring symptom severity of patients with schizophrenia. This is a 30-item instrument. Rating of each item is from (one, no evidence) to (seven, strong evidence) and the total score for overall psychopathology ranges from 30 to 210.	7 weeks
Secondary	Difficulties in Emotion Regulation Scale	A 36 item measure assesses individuals' typical levels of difficulties in emotion regulation	7 weeks
Secondary	Recovery Assessment Scale	38 items scale evaluate mental health recovery	7 weeks