Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder an… (NCT05809193) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder
Turkey (Türkiye)20 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range
15 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change from baseline to follow-up in Hamilton Depression Rating Scale (HDRS) scores
Timeframe: at baseline and at week 9
2
The change from baseline in Young Mania Rating Scale score
Timeframe: at baseline and at week 9
3
The change from baseline in Scale for the Assessment of Positive Symptoms (SAPS)
Timeframe: at baseline and at week 9
4
The change from baseline in Brief Negative Symptom Scale (BNSS)
Timeframe: at baseline and at week 9
5
The change from Personal and Social Performance Scale (PSP) scores
Timeframe: at baseline and at week 9
6
The change from Scale of Unawareness of Mental Disorder (SUMD) scores