Mental Disorder in AdolescenceNCT05809193
Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder
A study testing Family-Focused Therapy in people with Mental Disorder in Adolescence and Bipolar Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Mental Disorder in Adolescence, Bipolar Disorder, Psychosis
- What is being tested?
- Family-Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 31 Dec 2023
- 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 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Family-Focused Therapy
- Keywords
- family focused therapy, bipolar disorder, psychotic disorder, child, adolescent, early intervention
- Medical subject headings
- Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Focused TherapyBehavioural
After the patient and family are informed, they are included in the therapy group on a voluntary basis. After evaluation by independent evaluators, therapy sessions are started by therapists.
Session 1: Goal Setting, Treatment Overview, Symptoms, Vulnerability Stress Model Session 2: Stress and Coping Skills, Regulation of sleep habits, Relaxation exercises Session 3: Optimizing Family Support; Prevention Plan, Medication adherence Session 4: Overview of Communication Skills; Expressing Positive Feelings, Active Listening Session 5: Making Positive Requests for Change, Communication Clarity Session 6: Expressing Negative Feelings Session 7: Introduction to Problem Solving Skills Session 8 and 9: Problem Solving Skills, Termination of Treatment The same psychometric assessment will be repeated before and after FFT. Intra-group comparisons will be made. Also study groups will be compared using time by group interactions to investigate the differences in therapy response.
| Study group | Role | What they receive |
|---|---|---|
| Family-Focused Therapy | Experimental | Bipolar Disorder and Psychotic Disorder Receives: Behavioral: Family-Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline to follow-up in Hamilton Depression Rating Scale (HDRS) scores
by independent clinician/ to the patient - HDRS is a clinician-administered scale that measures the severity of depression. It contains 17 questions scored between 0-4. The total score of the scale ranges from 0 to 51. Cut-off points were determined as <7 normal, 8-13 mild, 14-18 moderate, 19-22 severe and >23 very severe.
Measured: at baseline and at week 9
The change from baseline in Young Mania Rating Scale score
by independent clinician/ to the patient - The Young Mania Rating Scale (YMRS) is a likert-type scale developed to measure the severity of manic symptoms. 7 of 11 items are graded in the range of 0-4, and the other 4 items are graded in the range of 0-8 points. Therapy sessions will be started if the Young Mania Rating Scale total score is ≤ 14 points. In addition, measurements will be repeated at the end of therapy.
Measured: at baseline and at week 9
The change from baseline in Scale for the Assessment of Positive Symptoms (SAPS)
by independent clinician/ to the patient - This scale aims to measure severity of positive symptoms in schizophrenia. It includes a total of 34 items in 4 subscales: hallucinations, delusions, bizarre behavior and positive formal thought disorder. Measurements will be made at the beginning and the difference will be examined by repeating at the end of the sessions.
Measured: at baseline and at week 9
The change from baseline in Brief Negative Symptom Scale (BNSS)
by independent clinician/ to the patient - BNSS consists of 13 items and has six subscales: anhedonia, stress, asociality, avolition, blunt affectivity, and alogia. The total score of the scale, which can range from 0 to 78, is obtained by summing the scores of 13 items. Measurements will be made at the beginning and the difference will be examined by repeating at the end of the sessions.
Measured: at baseline and at week 9
The change from Personal and Social Performance Scale (PSP) scores
by independent clinician/ to the patient - The scale evaluates personal and social performance in 4 sub-dimensions; Socially useful activities, personal and social relationships, self-care, irritating and aggressive behavior. 6-point Likert-type rating (1=absent - 6=very severe) was used.
Measured: at baseline and at week 9
The change from Scale of Unawareness of Mental Disorder (SUMD) scores
by independent clinician/ to the patient - SUMD was developed by Amador et al in 1993 to evaluate insight in psychiatric disorders. The Turkish reliability of this scale was determined by Bora E et al. (Bora et al. 2006). The scale is scored between 1-5 points and consists of 3 general items: being aware of mental disorders, being aware of the effects of drugs, and being aware of the social consequences of the disorder. High scores represent poor insight.
Measured: at baseline and at week 9
Secondary outcomes (6)
Coping Strategies Scale Brief Form (Brief COPE)
self report / to the patient - The Coping Strategies Short Form is the short form of the Coping Strategies (COPE) scale developed by Carver, Scheier, and Weintraub (1989), which measures people's different behaviors against stress, developed by Carver (1997). Coping Strategies Short Form consists of 14 subscales. It will be given at the beginning and at the end of the therapy sessions and the difference will be evaluated.
Measured: at baseline and at week 9
Shortened Level of Expressed Emotion Scale
self report / to the patient - The scale developed by Nelis et al. consists of 33 items measuring the perceived emotional expression of the most influential person in the participant's life in the last three months. The three subscales of the scale are lack of emotional support, irritability and intrusiveness. It will be given at the beginning and at the end of the therapy sessions and the difference will be evaluated.
Measured: at baseline and at week 9
World Health Organization Quality of Life Assessment (WHOQOL)
self report / to the patient and parent - The WHOQOL-BREF scale consists of a total of 26 questions, two questions about the general health, and 4 areas: physical health, psychological health, social relationships and environment. It will be given at the beginning and at the end of the therapy sessions and the difference will be evaluated.
Measured: at baseline and at week 9
Mc Master Family Assessment Device
self report / to the patient and parent - The scale, which consists of seven subscales called Problem Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behavior Control, and General Functioning, consists of 60 items. The scale is scored over four options varying between one and four points. Theoretically, two scores were accepted as a score distinguishing healthy and unhealthy functions. It can be applied to all family members over the age of twelve and to the subject himself to evaluate family functions. It will be given at the beginning and at the end of the therapy sessions and the difference will be evaluated.
Measured: at baseline and at week 9
Beck's Depression Inventory
self report / to parent - It is a widely used self-report scale developed by Beck in 1961. The Beck's Depression Inventory consists of 21 items related to depressive symptoms such as pessimism, sense of failure, dissatisfaction, feelings of guilt, restlessness, fatigue, decreased appetite, indecision, sleep disturbance, and social withdrawal. Each item gets a score between 0 and 3. The highest possible score is 63.
Measured: at baseline and at week 9
Zarit Burden Interview
self report / to parent - The scale, which can be filled in by the caregivers themselves or by the researcher, consists of 22 statements that determine the effect of caregiving on the individual's life. The scale has a Likert-type rating ranging from 0 to 4 as never, rarely, sometimes, often, or almost always.
Measured: at baseline and at week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2022
- Primary completion1 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorder in AdolescenceStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tevhide Ekin Sut, Dokuz Eylul University
- Investigators
- Neslihan Inal, M.D., Study director, Dokuz Eylul University Department of Child and Adolescent PsychiatryEmre Bora, M.D., Study director, Dokuz Eylul University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809193
- Sponsor's protocol ID
- 2022/11-07
- Status last verified
- Jun 2024
- First submitted
- 27 Mar 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder
- ClinicalTrials.gov ID
- NCT05809193
- Acronym / sponsor ID
- 2022/11-07
- Keywords
- family focused therapy, bipolar disorder, psychotic disorder, child, adolescent, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Apr 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family-Focused Therapy | Experimental | Behavioral: Family-Focused TherapyBipolar Disorder and Psychotic Disorder |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Family-Focused TherapyAfter the patient and family are informed, they are included in the therapy group on a voluntary basis. After evaluation by independent evaluators, therapy sessions are started by therapists. Session 1: Goal Setting, Treatment Overview, Symptoms, Vulnerability Stress Model Session 2: Stress and Coping Skills, Regulation of sleep habits, Relaxation exercises Session 3: Optimizing Family Support; Prevention Plan, Medication adherence Session 4: Overview of Communication Skills; Expressing Positive Feelings, Active Listening Session 5: Making Positive Requests for Change, Communication Clarity Session 6: Expressing Negative Feelings Session 7: Introduction to Problem Solving Skills Session 8 and 9: Problem Solving Skills, Termination of Treatment The same psychometric assessment will be repeated before and after FFT. Intra-group comparisons will be made. Also study groups will be compared using time by group interactions to investigate the differences in therapy response. | Behavioural | Family-Focused Therapy |
Primary outcome
The change from baseline to follow-up in Hamilton Depression Rating Scale (HDRS) scores
Time frame: at baseline and at week 9
by independent clinician/ to the patient - HDRS is a clinician-administered scale that measures the severity of depression. It contains 17 questions scored between 0-4. The total score of the scale ranges from 0 to 51. Cut-off points were determined as <7 normal, 8-13 mild, 14-18 moderate, 19-22 severe and >23 very severe.
The change from baseline in Young Mania Rating Scale score
Time frame: at baseline and at week 9
by independent clinician/ to the patient - The Young Mania Rating Scale (YMRS) is a likert-type scale developed to measure the severity of manic symptoms. 7 of 11 items are graded in the range of 0-4, and the other 4 items are graded in the range of 0-8 points. Therapy sessions will be started if the Young Mania Rating Scale total score is ≤ 14 points. In addition, measurements will be repeated at the end of therapy.
The change from baseline in Scale for the Assessment of Positive Symptoms (SAPS)
Time frame: at baseline and at week 9
by independent clinician/ to the patient - This scale aims to measure severity of positive symptoms in schizophrenia. It includes a total of 34 items in 4 subscales: hallucinations, delusions, bizarre behavior and positive formal thought disorder. Measurements will be made at the beginning and the difference will be examined by repeating at the end of the sessions.
The change from baseline in Brief Negative Symptom Scale (BNSS)
Time frame: at baseline and at week 9
by independent clinician/ to the patient - BNSS consists of 13 items and has six subscales: anhedonia, stress, asociality, avolition, blunt affectivity, and alogia. The total score of the scale, which can range from 0 to 78, is obtained by summing the scores of 13 items. Measurements will be made at the beginning and the difference will be examined by repeating at the end of the sessions.
The change from Personal and Social Performance Scale (PSP) scores
Time frame: at baseline and at week 9
by independent clinician/ to the patient - The scale evaluates personal and social performance in 4 sub-dimensions; Socially useful activities, personal and social relationships, self-care, irritating and aggressive behavior. 6-point Likert-type rating (1=absent - 6=very severe) was used.
The change from Scale of Unawareness of Mental Disorder (SUMD) scores
Time frame: at baseline and at week 9
by independent clinician/ to the patient - SUMD was developed by Amador et al in 1993 to evaluate insight in psychiatric disorders. The Turkish reliability of this scale was determined by Bora E et al. (Bora et al. 2006). The scale is scored between 1-5 points and consists of 3 general items: being aware of mental disorders, being aware of the effects of drugs, and being aware of the social consequences of the disorder. High scores represent poor insight.
6 secondary outcomes
Coping Strategies Scale Brief Form (Brief COPE)
Time frame: at baseline and at week 9
Shortened Level of Expressed Emotion Scale
Time frame: at baseline and at week 9
World Health Organization Quality of Life Assessment (WHOQOL)
Time frame: at baseline and at week 9
Mc Master Family Assessment Device
Time frame: at baseline and at week 9
Beck's Depression Inventory
Time frame: at baseline and at week 9
Zarit Burden Interview
Time frame: at baseline and at week 9
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 11 Jun 2024.
- 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.
Neslihan Inal, M.D. study director
Dokuz Eylul University Department of Child and Adolescent Psychiatry
Emre Bora, M.D. study director
Dokuz Eylul University Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Focused Therapy in people with Mental Disorder in Adolescence and Bipolar Disorder, run by Dokuz Eylul University 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 5 inclusion and 5 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 11 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?
The change from baseline to follow-up in Hamilton Depression Rating Scale (HDRS) scores (time frame: at baseline and at week 9). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2024.