PsychosisNCT06160869
Effect of Acceptance and Commitment Therapy on Psychotic Severity
A study testing Acceptance and commitment therapy and Treatment as usual in people with Psychosis and Emotion Regulation, run by Port Said University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis, Emotion Regulation, Recovery
- What is being tested?
- Acceptance and commitment therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychosis: A Randomized Controlled Trial.
Our study aims to assess the efficacy of Acceptance and Commitment Therapy on psychotic severity among Inpatients with primary psychosis: A Randomized Controlled Trial.
Read the detailed 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
- Conditions
- Psychosis, Emotion Regulation, Recovery
- Being tested
- Acceptance and commitment therapy, Treatment as usual
- Keywords
- Psychosis, Emotional regulation, Recovery
- Medical subject headings
- Psychotic Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
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 usualCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| ACT Group | Experimental | Received 90-minutes weekly group sessions of acceptence and commitment therapy plus treatment as usual. Receives: Behavioral: Acceptance and commitment therapy |
| Treatment as usual (TAU) group | Active comparator | Will receive the TAU alone Receives: Combination Product: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Secondary outcomes (2)
Difficulties in Emotion Regulation Scale
A 36 item measure assesses individuals' typical levels of difficulties in emotion regulation
Measured: 7 weeks
Recovery Assessment Scale
38 items scale evaluate mental health recovery
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Port Said University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Zoromba, PhD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160869
- Sponsor's protocol ID
- P.0553
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure privacy and confidentiality of participants their data will be secured
Publications
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.
PubMed 39034443
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychosis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06160869
- Acronym / sponsor ID
- P.0553
- Conditions
- Psychosis, Emotion Regulation, Recovery
- Keywords
- Psychosis, Emotional regulation, Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Port Said UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ACT Group | Experimental | Behavioral: Acceptance and commitment therapyReceived 90-minutes weekly group sessions of acceptence and commitment therapy plus treatment as usual. |
| Treatment as usual (TAU) group | Active comparator | Combination Product: Treatment as usualWill receive the TAU alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyThe 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. | Behavioural | ACT Group |
| Treatment as usualThe 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). | Combination product | Treatment as usual (TAU) group |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 7 weeks
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.
2 secondary outcomes
Difficulties in Emotion Regulation Scale
Time frame: 7 weeks
Recovery Assessment Scale
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 39034443Zoromba 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.
- Individual participant dataSharing planned: No. To ensure privacy and confidentiality of participants their data will be secured
Related trials for Psychosis
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Severe Mental Illness, Inflammation
RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Zoromba, PhD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy and Treatment as usual in people with Psychosis and Emotion Regulation, run by Port Said University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06160869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.