Effect of Acceptance and Commitment Therapy on Psychotic Severity

NCT06160869 | Unknown DMC

• 1 other identifier: P.0553
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis; Emotion Regulation; Recovery

Keywords

Psychosis; Emotional regulation; Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difficulties in Emotion Regulation Scale

  7 weeks

• Recovery Assessment Scale

  7 weeks

Study Arms (2)

ACT Group

EXPERIMENTAL

Received 90-minutes weekly group sessions of acceptence and commitment therapy plus treatment as usual.

Behavioral: Acceptance and commitment therapy

Treatment as usual (TAU) group

ACTIVE COMPARATOR

Will receive the TAU alone

Combination Product: Treatment as usual

Interventions

Acceptance and commitment therapy BEHAVIORAL

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.

ACT Group

Treatment as usual COMBINATION_PRODUCT

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).

Treatment as usual (TAU) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current psychiatric hospitalization;
• DSM-5 diagnosis of a primary psychotic disorder; (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder, brief psychotic disorder, and unspecified psychotic disorder, this diagnosis was confirmed by a psychiatrist
• years or older;
• ability to talk, read and write in Arabic; and
• willingness to participate in the study that was scheduled for seven weeks.

You may not qualify if:

• had a comorbid learning disability or organic brain disorder;
• psychosis related to a general medical condition or substance-induced psychotic disorder;
• were considered mentally unstable; or
• unfit to participate in the study by their therapist, and/or had newly had (been receiving) psycho-education or somewhat designed psychosocial intervention.

Sponsors & Collaborators

• Port Said University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 25711, Egypt

Location

Related Publications (1)

• Zoromba MA, Sefouhi L, Alenezi A, Selim A, Awad S, El-Gazar HE, El-Monshed AH. Effectiveness of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychoses: A Randomized Controlled Trial. Int J Ment Health Nurs. 2024 Dec;33(6):2239-2256. doi: 10.1111/inm.13388. Epub 2024 Jul 21.

  PMID: 39034443 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Emotional Regulation

Interventions

Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mohamed Zoromba, PhD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Information is not withheld from trial participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Current study is 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

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 20, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)