First Psychotic AttackNCT06655688
Acceptance and Commitment Therapy (ACT) for Family Members After a First Psychotic Attack
A study testing Acceptance and Commitment Therapy in people with First Psychotic Attack and Family Members, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- First Psychotic Attack, Family Members, Acceptance and Commitment Therapy
- 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
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 1 Jun 2025
- 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
- Acceptance to participate in the research,
- Being responsible for the care of an individual who has been diagnosed with schizophrenia and other psychotic disorders according to DSM-5 diagnostic criteria at least six months ago and at most five years ago,
- Living with the patient for at least one year,
- First-degree relatives (mother, father, siblings, adult children and spouse),
- The home environment is suitable for online interviewing (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
- Being literate,
- Communication is not a problem.
Who cannot join
- Refusal to participate in the research,
- Responsible for the care of an individual diagnosed with schizophrenia and other psychotic disorders for less than six months or more than five years according to DSM-V diagnostic criteria,
- Living with the patient for less than one year,
- No first-degree relatives (mother, father, siblings, adult children and spouse),
- The home environment is not suitable for online counseling (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
- Illiteracy,
- Communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acceptance and Commitment Therapy on Self-Stigmatization, Coping With Stress and Psychological Resilience Levels of Family Members After First Psychotic Attack Diagnosis
This study aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA).
Read the detailed description
This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted with family members of individuals diagnosed with FPA who come to the psychiatry outpatient clinic of a training and research hospital. According to the results of G-power analysis, the minimum sample size of the study was calculated as 32 (intervention 16, control 16). Personal Information Form will be applied to the individuals before randomization. The computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control groups without bias. It is planned that the intervention group will consist of 8-12 participants and the program will be implemented as two intervention groups. The Acceptance and Commitment Therapy (ACT) Based Intervention Program will be implemented online in eight sessions. Each session will last 60-90 minutes on average. Two sessions will be held for one group per week. The control group will not receive any intervention from the researcher. The intervention groups will be followed up with a post-test after the program is completed and three months later, while the control group will be followed up with a post-test four weeks and three months later.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilized studies in the literature and the basic ACT training she had received. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- First psychotic attack, family members, Acceptance and Commitment Therapy, group therapy, coping, stigmatization, psychiatric nursing
- Medical subject headings
- Stereotyping
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 |
|---|---|---|
| Experimental: 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 | Arm Description: 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.
Self-Stigma Inventory for Families (SSI-F)
The scale was developed to assess the self-stigmatization of family members of individuals diagnosed with schizophrenia. The scores that can be obtained from the scale, which includes 3 factors and 14 items in total, including internalized stereotypes and withdrawal from society, concealment of the disease and perceived worthlessness, vary between 14-70. A high score indicates a high level of self-stigmatization of the family member.
Measured: 6 month
Secondary outcomes (2)
Stress Coping Scale
The scale consists of 23 items and is a 5-point Likert type. It includes 3 sub-dimensions: seeking social support, problem-focused coping and avoidance-focused coping. Items 10, 17 and 20 of the scale are reverse-scored. The total score and subscale scores obtained from the scale provide information about individuals' coping strategies with stress. The scale gives scores ranging from 23 to 115 reflecting the general level of coping strategies used by individuals to cope with stress. High scores obtained from the scale and its subscales indicate an increased tendency to use relevant coping mechanisms.
Measured: 6 month
Brief Resilience Scale
The scale was developed to measure the psychological resilience of individuals. This scale, which consists of 6 items in 5-point Likert type, is a self-report measurement tool. It is scored between "not at all appropriate" (1) and "completely appropriate" (5). Items 2, 4 and 6 of these 6 items are reverse coded. High scores indicate a high level of psychological resilience and low scores indicate a low level of psychological resilience.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start20 Oct 2024
- Primary completion30 Nov 2024
- Study completion1 Jun 2025
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 First Psychotic AttackStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Özer, PhD, Istanbul Saglik Bilimleri University
- Investigators
- Duygu Özer, Asst. Prof., Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655688
- Sponsor's protocol ID
- BARU-SBF-DO-1
- Status last verified
- May 2026
- First submitted
- 19 Oct 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozer D. Effects of Online Acceptance and Commitment Therapy for Family Members of Individuals With Early Psychosis on Self-Stigma, Coping Strategies and Resilience: A Randomized Controlled Trial. J Psychiatr Ment Health Nurs. 2026 Aug;33(4):599-613. doi: 10.1111/jpm.70130. Epub 2026 Apr 14.
PubMed 41981886
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy on Self-Stigmatization, Coping With Stress and Psychological Resilience Levels of Family Members After First Psychotic Attack Diagnosis
- ClinicalTrials.gov ID
- NCT06655688
- Acronym / sponsor ID
- BARU-SBF-DO-1
- Keywords
- First psychotic attack, family members, Acceptance and Commitment Therapy, group therapy, coping, stigmatization, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 23 Oct 2024 (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 aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA).
Detailed description
This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted with family members of individuals diagnosed with FPA who come to the psychiatry outpatient clinic of a training and research hospital. According to the results of G-power analysis, the minimum sample size of the study was calculated as 32 (intervention 16, control 16). Personal Information Form will be applied to the individuals before randomization. The computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control groups without bias. It is planned that the intervention group will consist of 8-12 participants and the program will be implemented as two intervention groups. The Acceptance and Commitment Therapy (ACT) Based Intervention Program will be implemented online in eight sessions. Each session will last 60-90 minutes on average. Two sessions will be held for one group per week. The control group will not receive any intervention from the researcher. The intervention groups will be followed up with a post-test after the program is completed and three months later, while the control group will be followed up with a post-test four weeks and three months later.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilized studies in the literature and the basic ACT training she had received. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Experimental: ACT | Experimental | Behavioral: Acceptance and Commitment Therapy''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group. |
| Control | No intervention | –Arm Description: 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 (7 listed)
- Acceptance to participate in the research,
- Being responsible for the care of an individual who has been diagnosed with schizophrenia and other psychotic disorders according to DSM-5 diagnostic criteria at least six months ago and at most five years ago,
- Living with the patient for at least one year,
- First-degree relatives (mother, father, siblings, adult children and spouse),
- The home environment is suitable for online interviewing (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
Key exclusion criteria (7 listed)
- Refusal to participate in the research,
- Responsible for the care of an individual diagnosed with schizophrenia and other psychotic disorders for less than six months or more than five years according to DSM-V diagnostic criteria,
- Living with the patient for less than one year,
- No first-degree relatives (mother, father, siblings, adult children and spouse),
- The home environment is not suitable for online counseling (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
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 | Experimental: ACT |
Primary outcome
Self-Stigma Inventory for Families (SSI-F)
Time frame: 6 month
The scale was developed to assess the self-stigmatization of family members of individuals diagnosed with schizophrenia. The scores that can be obtained from the scale, which includes 3 factors and 14 items in total, including internalized stereotypes and withdrawal from society, concealment of the disease and perceived worthlessness, vary between 14-70. A high score indicates a high level of self-stigmatization of the family member.
2 secondary outcomes
Stress Coping Scale
Time frame: 6 month
Brief Resilience Scale
Time frame: 6 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 May 2026.
- Derived from this study: PubMed 41981886Ozer D. Effects of Online Acceptance and Commitment Therapy for Family Members of Individuals With Early Psychosis on Self-Stigma, Coping Strategies and Resilience: A Randomized Controlled Trial. J Psychiatr Ment Health Nurs. 2026 Aug;33(4):599-613. doi: 10.1111/jpm.70130. Epub 2026 Apr 14.
- Individual participant dataSharing planned: No
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, Asst. Prof. principal investigator
Bartın Unıversity
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 First Psychotic Attack and Family Members, 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 7 inclusion and 7 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 May 2026. 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?
Self-Stigma Inventory for Families (SSI-F) (time frame: 6 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 NCT06655688, 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 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.