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

NCT ID: NCT05809193

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family-Focused Therapy

Bipolar Disorder and Psychotic Disorder

Group Type: EXPERIMENTAL

Family-Focused Therapy

Intervention Type: 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.

Interventions

Family-Focused Therapy

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Tevhide Ekin Sut

M.D., Department of Child and Adolescent Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neslihan Inal, M.D.

Role: STUDY_DIRECTOR

Dokuz Eylul University Department of Child and Adolescent Psychiatry

Emre Bora, M.D.

Role: STUDY_DIRECTOR

Dokuz Eylul University Department of Psychiatry

Locations

Dokuz Eylül University

Izmir, Balcova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/11-07

Identifier Type: -

Identifier Source: org_study_id