search
Back to results

Strengths-Based Family Psychoeducation for Youth Psychosis

Primary Purpose

Psychological Stresses

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Strengths-based family psychoeducation
Sponsored by
Nagoya City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychological Stresses focused on measuring Psychotherapy, Psychotic disorders, Caregiver

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient

    1. whose age is between 15 and 39 years old
    2. who currently takes outpatient treatment
    3. who fulfills the diagnostic criteria of the DSM-IV-TR for schizophrenia, brief psychotic disorder, schizophreniform disorder, schizoaffective disorder or delusional disorder
    4. who is a native speaker of Japanese
  • The family

    1. whose age is between 20 and 74 years old
    2. who is classified as one of the four relationships with the patient; parent, spouse, sibling and someone who has been living together more than 3 months
    3. who is a native speaker of Japanese

Exclusion Criteria:

  • The patient

    1. who fulfills the diagnostic criteria of the DSM-IV-TR for mood disorders with psychotic features, substance-induced psychotic disorder or psychotic disorder due to the general medical condition
    2. who has been diagnosed with mental retardation or cluster B personality disorders by the doctor in charge
  • The family

    1. who has a communication problem for any reason (e.g. psychotic disorders, dementia or cluster B personality disorders)
    2. who is judged not suitable for participating in this study for any reason by the doctor in charge of the patient

Sites / Locations

  • Kusunokikai Kusunoki Mental Hospital
  • Shiseikai Yagoto Hospital
  • Kyouseikai Minamichita Hospital
  • Kenseikai Toyota-nishi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strengths-based family psychoeducation

Waiting list

Arm Description

Family psychoeducation in addition to treatment as usual

Treatment as usual

Outcomes

Primary Outcome Measures

Change from baseline in the total score of trait anxiety of the Japanese version of the STAI at 14 weeks
The STAI is a self-report questionnaire to measure the intensity of anxiety. It consists of two categories that are state and trait anxiety. Trait anxiety measures relatively stable responses to anxiety-provoking experiences.

Secondary Outcome Measures

Change from baseline in the proportion of the Japanese version of the K6 whose total score is less than nine at 14 weeks.
The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health. The cutoff point is nine. Nine and more scores suggest that 50 percent of the subjects might be depressive or anxiety disorder.

Full Information

First Posted
November 18, 2012
Last Updated
January 2, 2016
Sponsor
Nagoya City University
Collaborators
Aichi Health Promotion Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01731977
Brief Title
Strengths-Based Family Psychoeducation for Youth Psychosis
Official Title
Effectiveness of the Strengths-Based Family Psychoeducation for Youth Psychosis: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya City University
Collaborators
Aichi Health Promotion Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The onset of Psychosis forces family members to bear a heavy burden of care. The mental well-being of the family is so complicated that it is important to relieve their psychological stresses. Although family psychoeducation has been established as an evidence-based practice especially for schizophrenia, few studies have primarily intended to reduce the distress of the family due to the burden of care. MacFarlane's multifamily psychoeducation is one of the representative models of a group setting, which is based on the behavioral therapeutic approach. In such psychological interventions, it has been emphasized to focus on the strengths that a person originally has for coping with difficulties. The intervention of mainly drawing the strengths from the family might empower them and lighten their psychological burden. The first 2-5 years from the onset of psychosis is regarded as the critical period to improve the prognosis, so the intervention including more recent-onset psychotic patients might be of use. With regard to a setting of the psychoeducational intervention, a homogeneous group one can make the program better fitted for their problems. The present study aims to examine if the strength-based family psychoeducaiton for youth psychosis in a group setting in addition to the treatment as usual would be more effective for alleviating the psychological distresses of the family than the treatment as usual alone. Moreover, its impact on the family of recent-onset psychosis is explored as the subgroup.
Detailed Description
Psychosis, principally involving schizophrenia, is a severe mental illness that commonly develops at a young age and often has a chronic course. The onset of Psychosis forces family members to bear a heavy burden of care. It has been documented over and over again that the mental well-being of the family is complicated. More than a dozen per cent of the family have the morbidity corresponding to be depressive and anxiety disorders. It is important to relieve their psychological stresses. The concept of the burden of care is so broad and complex that its simple definition is a challenging issue. It is usually defined as objective impacts on the household and subjective consequences, which contain physical, economic, emotional and psychological components. The psychological component involves the stigma against psychiatric disorders. The studies of intervention to the family having a psychotic member have been mostly conducted for the primary interest of reducing the rate of relapse and rehospitalization of the psychotic. Their rationale of the intervention is based on the roles of the family that develop the illness and cause a relapse (e.g., etiological relationship or expressed emotion). Although family psychoeducation has been established as an evidence-based practice especially for schizophrenic patients, few studies have primarily intended to reduce the burden of their family. Among various types of family psychoeducation, the group setting is considered as a better method in terms of the creation of social support networks, limited medical resources and cost-effectiveness. MacFarlane's multifamily psychoeducation is one of the representative models of a group setting, which is composed of joining sessions, an educational workshop and structured problem-solving group sessions. MacFarlane's model is based on the behavioral therapeutic approach that mainly aims at stopping a vicious cycle. The cycle of schizophrenia is peculiarly caused by expressed emotion, which is negative one expressed by the family that lead to a high relapse rate (e.g., hostility or criticism). In such psychological interventions, it has been emphasized to focus not only on the vicious cycle but also on strengths. The strengths are defined as the power that a person has originally for coping with difficulties. The intervention of mainly drawing out the strengths of the family might empower them to face difficulties voluntarily and lighten their psychological burden. However, to date, the effectiveness of family psychoeducation based on the strengths approach has not been confirmed. The onset of psychosis is generally at a young age. The first 2-5 years from the onset of psychosis is regarded as the critical period to improve the prognosis, so the intervention including more recent-onset psychotic patients might be of use. Additionally, the family of a young patient has been reported to have strong concerns about returning to school, going to work and getting married. With regard to a setting of the psychoeducational intervention, a homogeneous group one can make the program better fitted for their problems and heighten group cohesiveness. The present study aims to examine if the strength-based family psychoeducaiton for youth psychosis in a group setting in addition to the treatment as usual would be more effective for alleviating the psychological distresses of the family than the treatment as usual alone. Moreover, its impact on the family of recent-onset psychosis is explored as the subgroup.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stresses
Keywords
Psychotherapy, Psychotic disorders, Caregiver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strengths-based family psychoeducation
Arm Type
Experimental
Arm Description
Family psychoeducation in addition to treatment as usual
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Strengths-based family psychoeducation
Intervention Description
Family psychoeducation in a group setting is performed every two weeks for eight weeks.
Primary Outcome Measure Information:
Title
Change from baseline in the total score of trait anxiety of the Japanese version of the STAI at 14 weeks
Description
The STAI is a self-report questionnaire to measure the intensity of anxiety. It consists of two categories that are state and trait anxiety. Trait anxiety measures relatively stable responses to anxiety-provoking experiences.
Time Frame
Baseline, 10 weeks, 14 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the proportion of the Japanese version of the K6 whose total score is less than nine at 14 weeks.
Description
The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health. The cutoff point is nine. Nine and more scores suggest that 50 percent of the subjects might be depressive or anxiety disorder.
Time Frame
Baseline, 10 weeks, 14 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in the total score of the Japanese vesion of the Link's stigma scale
Description
The Link's stigma scale is a self-report questionnaire to measure the intensity of stigma attached to mental disorders. This scale is intended for general citizens, patients and their family.
Time Frame
Baseline, 10 weeks, 14 weeks
Title
Change from baseline in the total score of state anxiety of the Japanese version of the STAI
Description
State Anxiety measures temporary situational responses to anxiety-provoking experiences.
Time Frame
Baseline, 10 weeks, 14 weeks
Title
Change from baseline in the total score of the short version of the Japanese version of the Zarit Burden Interview (J-ZBI-8).
Description
The J-ZBI-8 is a self-report questionnaire to measure the intensity of family care burden. The 8-items short version was developed from the Zarit Burden Interview that contains twenty-two items.
Time Frame
Baseline, 10 weeks, 14 weeks
Title
Change from baseline in the total score of the Japanese version of the family Attitude Scale (FAS).
Description
The FAS is a self-report questionnaire to measure the intensity of expressed emotion (EE). Hostility, high criticism and low warmth on the Camberwell Family Interview that is the gold standard to masure EE are associated with a higher scores of the FAS.
Time Frame
Baseline, 10 weeks, 14 weeks
Title
Change from baseline in the total score of the Japanese version of the K6
Description
The K6 is a self-report questionnaire to measure mental well-being. The range of the score is 0 to 24 and a higher score indicates having poor mental health.
Time Frame
Baseline, 10 weeks, 14 weeks
Title
Change from baseline in the score of the Japanese version of the Global Assessment of Functioning (GAF)
Description
The GAF is an analogous scale that evaluates the current objective symptomatic and functional conditions of patients. The range of the score is 0 to 100 and a higher score indicates having better conditions.
Time Frame
Baseline, 10 weeks, 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient whose age is between 15 and 39 years old who currently takes outpatient treatment who fulfills the diagnostic criteria of the DSM-IV-TR for schizophrenia, brief psychotic disorder, schizophreniform disorder, schizoaffective disorder or delusional disorder who is a native speaker of Japanese The family whose age is between 20 and 74 years old who is classified as one of the four relationships with the patient; parent, spouse, sibling and someone who has been living together more than 3 months who is a native speaker of Japanese Exclusion Criteria: The patient who fulfills the diagnostic criteria of the DSM-IV-TR for mood disorders with psychotic features, substance-induced psychotic disorder or psychotic disorder due to the general medical condition who has been diagnosed with mental retardation or cluster B personality disorders by the doctor in charge The family who has a communication problem for any reason (e.g. psychotic disorders, dementia or cluster B personality disorders) who is judged not suitable for participating in this study for any reason by the doctor in charge of the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nao Shiraishi, MD
Organizational Affiliation
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kusunokikai Kusunoki Mental Hospital
City
Nagoya City
State/Province
Aichi Prefecture
ZIP/Postal Code
462-0011
Country
Japan
Facility Name
Shiseikai Yagoto Hospital
City
Nagoya City
State/Province
Aichi Prefecture
ZIP/Postal Code
468-0073
Country
Japan
Facility Name
Kyouseikai Minamichita Hospital
City
Nagoya City
State/Province
Aichi Prefecture
ZIP/Postal Code
470-3411
Country
Japan
Facility Name
Kenseikai Toyota-nishi Hospital
City
Toyota City
State/Province
Aichi Prefecture
ZIP/Postal Code
470-0344
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31477061
Citation
Shiraishi N, Watanabe N, Katsuki F, Sakaguchi H, Akechi T. Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial. BMC Psychiatry. 2019 Sep 2;19(1):263. doi: 10.1186/s12888-019-2252-y.
Results Reference
derived

Learn more about this trial

Strengths-Based Family Psychoeducation for Youth Psychosis

We'll reach out to this number within 24 hrs