Clinical trial NCT05809193: Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder
Official title: Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder in Adolescence
Bipolar Disorder
Psychosis
Family Relations
Keywords: family focused therapy
bipolar disorder
psychotic disorder
child
adolescent
early intervention
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It is aimed to examine the effects of family-focused therapy, which will be applied in the early period to individuals who have been diagnosed with bipolar disorder and psychotic disorder and who have achieved remission, and their families. It will be carried out using the guide "Family-Focused Therapy for High-Risk Adolescents and Young Adults for Bipolar Disorder or Psychosis" revised by Miklowitz et al. in 2018. In terms of practical application, the sessions will be psychoeducational sessions that will be held in groups of 3 sessions, 3 sessions with the youth and the family. communication skills sessions to be held individually and 3 sessions as problem solving skills sessions to be held individually with the youth and family will be completed in 9 sessions. Sessions will be held once a week and all sessions will be completed in 9 weeks.
Primary purpose: TREATMENT

Brief summary: Family-focused therapy (FFT) is a comprehensive therapy approach applied to individuals and their families. In the present study, the researchers aimed to investigate the effects of family-focused therapy (FFT) in the early stages of psychotic disorder and bipolar disorder, regarding the psychiatric symptomatology, family communication skills, coping capacities, family burden and quality of life. A total of 34 young people diagnosed with bipolar disorder (BD) and 17 psychotic disorders (PD) will be included in the study.

Detailed description: In this study, the researcher's primary goal is to investigate the effects of family-focused therapy sessions on young people aged between 15 and 21. Subjects were referred to an early intervention center for psychotic and bipolar disorders. The target population of the study consists of the patients in remission after the episode of the illness.

Therapy sessions will be conducted in line with the manual for "Family Focused Therapy for High-Risk Adolescents and Young Adults for Bipolar Disorder or Psychosis" revised by Miklowitz et al. in 2018. FFT will be completed in nine sessions. The first module of the program consists of three sessions, which consists of group psychoeducation for the patients and families. The second and third modules also include three sessions in each to teach communication skills and problem-solving skills in individual therapy sessions including patients and their families. Sessions will be held once a week and completed in nine weeks.

Within the scope of this program, non-therapist clinicians will evaluate the participants' symptoms, psychosocial functioning, insight, and treatment compliance before and after the therapy sessions.

There are only a few previous studies investigating the effects of family therapy in early stages of bipolar disorder and psychotic disorder. According to the literature, no prior study compares the effects of FFT between BD and PD populations. This study is important in terms of developing effective strategies for management of psychosocial difficulties in early phases of BD and PDs.

Eligibility criteria: Inclusion Criteria:

* Not be in an active phase of the illness
* Able to comply with the interviews
* The total score of the Hamilton Depression Rating Scale ≤ 21 points.
* The total score of the Young Mania Rating Scale ≤ 14 points.
* At least one family member with the capacity to read and write in Turkish

Exclusion Criteria:

* Neurological disorders and serious physical disease that affect cognitive functions
* The symptoms due to substance use or a medical illness
* Autism Spectrum Disorder
* Comorbid alcohol and substance abuse (except nicotine)
* Co-morbid psychiatric disorders except disruptive behavior disorders and anxiety disorders

Primary outcomes:
measure: The change from baseline to follow-up in Hamilton Depression Rating Scale (HDRS) scores
timeFrame: at baseline and at week 9
measure: The change from baseline in Young Mania Rating Scale score
timeFrame: at baseline and at week 9
measure: The change from baseline in Scale for the Assessment of Positive Symptoms (SAPS)
timeFrame: at baseline and at week 9
measure: The change from baseline in Brief Negative Symptom Scale (BNSS)
timeFrame: at baseline and at week 9
measure: The change from Personal and Social Performance Scale (PSP) scores
timeFrame: at baseline and at week 9
measure: The change from Scale of Unawareness of Mental Disorder (SUMD) scores
timeFrame: at baseline and at week 9
Secondary outcomes:
measure: Coping Strategies Scale Brief Form (Brief COPE)
timeFrame: at baseline and at week 9
measure: Shortened Level of Expressed Emotion Scale
timeFrame: at baseline and at week 9
measure: World Health Organization Quality of Life Assessment (WHOQOL)
timeFrame: at baseline and at week 9
measure: Mc Master Family Assessment Device
timeFrame: at baseline and at week 9
measure: Beck's Depression Inventory
timeFrame: at baseline and at week 9
measure: Zarit Burden Interview
timeFrame: at baseline and at week 9
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
state: Balcova
Study officials:
affiliation: Dokuz Eylul University Department of Child and Adolescent Psychiatry
name: Neslihan Inal, M.D.
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University Department of Psychiatry
name: Emre Bora, M.D.
role: STUDY_DIRECTOR
References: