Acceptance and Commitment TherapyNCT05210816
Acceptance and Commitment Therapy (ACT) in Early Psychosis Patients
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy and Psychotic Disorders, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study is to examine the effect of Acceptance and Commitment Therapy applied to patients in early psychosis patients on psychotic symptoms and functionality levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acceptance and Commitment Therapy, Psychotic Disorders, Psychiatric Nursing
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Sep 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The consent of himself/herself or his/she guardian to participate in the research,
- Being diagnosed with schizophrenia and other psychotic disorders for a minimum of six months and a maximum of three years according to DSM-V diagnostic criteria,
- Not to be in the acute attack period of the disease,
- The home environment is suitable for online conversation (computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.)
- Being between the ages of 18-65,
- Ability to read and write,
- There is no communication problem at a level that prevents the conversation,
- Absence of mental retardation, neurocognitive disorder, alcohol and substance abuse
Who cannot join
- Her/his is or her/his is guardian's refusal to participate in the research,
- Being diagnosed with schizophrenia and other psychotic disorders for less than six months or for more than three years, according to DSM-V diagnostic criteria,
- Being in the acute attack period of the disease,
- Not being able to read and write,
- Having a communication problem at a level that prevents the conversation,
- Having mental retardation, neurocognitive disorder, alcohol and substance addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acceptance and Commitment Therapy on Psychotic Symptoms and Functioning Levels in Early Psychosis Patients
This study is to examine the effect of Acceptance and Commitment Therapy applied to patients in early psychosis patients on psychotic symptoms and functionality levels.
Read the detailed description
This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted at the Health Sciences University Sultan II. Abdulhamid Han Training and Research Hospital, Department of Psychiatry. According to the G-power analysis results, the minimum sample size of the study was calculated as 40 (intervention 20, control 20). Before randomization, the Personal Information Form and P1-P3 questions on the Positive and Negative Syndrome Scale (PANNS) will be applied to the patients in order to identify the patients with early psychosis. Computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control group without bias. It is planned that the intervention group will consist of at least 8 participants and the program will be implemented as three intervention groups. Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week. The control group will not receive any intervention by the researcher, and participants will continue with their routine treatment plan. The intervention groups after the program is completed and three months later, follow-up will be done by applying the post-test, while the control group will be followed-up by applying the post-test four weeks and three months later.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilised studies in the literature and the basic ACT training she had received. After preparation of the ACT intervention protocol, it was given its final shape by obtaining the views of specialists working in this field. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Early psychosis, Psychotic symptom, Functionality, Psychiatric Nursing, Early intervention
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week.
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | ''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group. Receives: Behavioral: Acceptance and Commitment Therapy |
| Control | No intervention | Only data collection was carried out. No attempt was made by the researcher during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
The PANNS scale provides an assessment of the severity of psychotic symptoms. Data is collected by the researcher through a semi-structured interview with the patients. In the scale consisting of 30 spiritual parameters; seven of them belong to the positive symptoms subscale, seven to the negative symptoms subscale, and the remaining sixteen to the general psychopathology subscale. The total score varies between 30-210. A total score of 58-74 from the scale is defined as mild, 75-94 points as moderate, 95-115 points as marked disease, and 116 and above points as severe disease.
Measured: 9 month
Secondary outcomes (1)
Social Functioning Assessment Scale
It is a 19-item Likert-type scale developed for schizophrenia patients. Each item is in the range of 1-3 points. It is seen that the scale consists of four factors as interpersonal relations and entertainment, self-care, independent living skills and working life. The score that can be obtained from the scale is in the range of 19-57, and a high score from the scale means that the individual has a high level of social functionality.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
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 Acceptance and Commitment TherapyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duygu ÖZER, MsN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210816
- Sponsor's protocol ID
- SY200217B09
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozer D, Dissiz M. The effect of online group based acceptance and commitment therapy on psychotic symptoms and functioning levels of individuals with early psychosis. Schizophr Res. 2024 May;267:55-64. doi: 10.1016/j.schres.2024.03.018. Epub 2024 Mar 22.
PubMed 38518479
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy on Psychotic Symptoms and Functioning Levels in Early Psychosis Patients
- ClinicalTrials.gov ID
- NCT05210816
- Acronym / sponsor ID
- SY200217B09
- Keywords
- Acceptance and Commitment Therapy, Early psychosis, Psychotic symptom, Functionality, Psychiatric Nursing, Early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Jan 2022 (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.
This study is to examine the effect of Acceptance and Commitment Therapy applied to patients in early psychosis patients on psychotic symptoms and functionality levels.
Detailed description
This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted at the Health Sciences University Sultan II. Abdulhamid Han Training and Research Hospital, Department of Psychiatry. According to the G-power analysis results, the minimum sample size of the study was calculated as 40 (intervention 20, control 20). Before randomization, the Personal Information Form and P1-P3 questions on the Positive and Negative Syndrome Scale (PANNS) will be applied to the patients in order to identify the patients with early psychosis. Computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control group without bias. It is planned that the intervention group will consist of at least 8 participants and the program will be implemented as three intervention groups. Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week. The control group will not receive any intervention by the researcher, and participants will continue with their routine treatment plan. The intervention groups after the program is completed and three months later, follow-up will be done by applying the post-test, while the control group will be followed-up by applying the post-test four weeks and three months later.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilised studies in the literature and the basic ACT training she had received. After preparation of the ACT intervention protocol, it was given its final shape by obtaining the views of specialists working in this field. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: Acceptance and Commitment Therapy''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group. |
| Control | No intervention | –Only data collection was carried out. No attempt was made by the researcher during the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The consent of himself/herself or his/she guardian to participate in the research,
- Being diagnosed with schizophrenia and other psychotic disorders for a minimum of six months and a maximum of three years according to DSM-V diagnostic criteria,
- Not to be in the acute attack period of the disease,
- The home environment is suitable for online conversation (computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.)
- Being between the ages of 18-65,
Key exclusion criteria (6 listed)
- Her/his is or her/his is guardian's refusal to participate in the research,
- Being diagnosed with schizophrenia and other psychotic disorders for less than six months or for more than three years, according to DSM-V diagnostic criteria,
- Being in the acute attack period of the disease,
- Not being able to read and write,
- Having a communication problem at a level that prevents the conversation,
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 TherapyAcceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week. | Behavioural | ACT |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 9 month
The PANNS scale provides an assessment of the severity of psychotic symptoms. Data is collected by the researcher through a semi-structured interview with the patients. In the scale consisting of 30 spiritual parameters; seven of them belong to the positive symptoms subscale, seven to the negative symptoms subscale, and the remaining sixteen to the general psychopathology subscale. The total score varies between 30-210. A total score of 58-74 from the scale is defined as mild, 75-94 points as moderate, 95-115 points as marked disease, and 116 and above points as severe disease.
1 secondary outcome
Social Functioning Assessment Scale
Time frame: 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 38518479Ozer D, Dissiz M. The effect of online group based acceptance and commitment therapy on psychotic symptoms and functioning levels of individuals with early psychosis. Schizophr Res. 2024 May;267:55-64. doi: 10.1016/j.schres.2024.03.018. Epub 2024 Mar 22.
- Individual participant dataSharing planned: No
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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.
Duygu ÖZER, MsN principal investigator
Saglik Bilimleri Universitesi
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 in people with Acceptance and Commitment Therapy and Psychotic Disorders, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jun 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 9 month). 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 NCT05210816, 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 Jun 2024.