Investigation of the Effects of Family-Focused Therapy in the Early Period of Bipolar Disorder and Psychotic Disorder

NCT05809193 | Completed

• 1 other identifier: 2022/11-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder in Adolescence; Bipolar Disorder; Psychosis; Family Relations

Keywords

family focused therapy; bipolar disorder; psychotic disorder; child; adolescent; early intervention

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  at baseline and at week 9

Secondary Outcomes (6)

• Coping Strategies Scale Brief Form (Brief COPE)

  at baseline and at week 9

• Shortened Level of Expressed Emotion Scale

  at baseline and at week 9

• World Health Organization Quality of Life Assessment (WHOQOL)

  at baseline and at week 9

• Mc Master Family Assessment Device

  at baseline and at week 9

• Beck's Depression Inventory

  at baseline and at week 9

Study Arms (1)

Family-Focused Therapy

EXPERIMENTAL

Bipolar Disorder and Psychotic Disorder

Behavioral: Family-Focused Therapy

Interventions

Family-Focused Therapy BEHAVIORAL

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.

Family-Focused Therapy

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, Balcova, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Neslihan Inal, M.D.

  Dokuz Eylul University Department of Child and Adolescent Psychiatry

  STUDY DIRECTOR

• Emre Bora, M.D.

  Dokuz Eylul University Department of Psychiatry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Department of Child and Adolescent Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)