Effect of Acceptance and Commitment Therapy on Psychotic Severity

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Psychosis, Emotion Regulation, Recovery

Intervention / Treatment
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* Behavioral: Acceptance and commitment therapy
* Combination Product: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Participants' criteria of inclusion involved those patients who were 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 18 years or older; ability to talk, read and write in Arabic; and willingness to participate in the study that was scheduled for seven weeks. Exclusion criteria Patients were excluded if they 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT Group<br>Received 90-minutes weekly group sessions of acceptence and commitment therapy plus treatment as usual. | Behavioral: Acceptance and commitment therapy<br>* 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.<br>|
| Active Comparator: Treatment as usual (TAU) group<br>Will receive the TAU alone | Combination Product: Treatment as usual<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties in Emotion Regulation Scale | A 36 item measure assesses individuals' typical levels of difficulties in emotion regulation | 7 weeks | 
| Recovery Assessment Scale | 38 items scale evaluate mental health recovery | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Emotional regulation, Recovery