Clinical trial NCT06655688: Acceptance and Commitment Therapy (ACT) for Family Members After a First Psychotic Attack
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: First Psychotic Attack
Family Members
Acceptance and Commitment Therapy
Keywords: First psychotic attack
family members
Acceptance and Commitment Therapy
group therapy
coping
stigmatization
psychiatric nursing
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Self-Stigma Inventory for Families (SSI-F)
timeFrame: 6 month
Secondary outcomes:
measure: Stress Coping Scale
timeFrame: 6 month
measure: Brief Resilience Scale
timeFrame: 6 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Bartın Unıversity
name: Duygu Özer, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: