Effect of Acceptance and Commitment Therapy on Psychotic Severity

NCT ID: NCT06160869

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2023-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychosis Emotion Regulation Recovery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Psychosis Emotional regulation Recovery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Information is not withheld from trial participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACT Group

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

Group Type EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type 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.

Treatment as usual (TAU) group

Will receive the TAU alone

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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).

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Current psychiatric hospitalization;
2. 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
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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Port Said University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed Zoromba, PhD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39034443 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.0553

Identifier Type: -

Identifier Source: org_study_id