NCT01731977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

3.5 years

First QC Date

November 18, 2012

Last Update Submit

January 2, 2016

Conditions

Psychological Stresses

Keywords

Psychotherapy, Psychotic disorders, Caregiver

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 10 weeks, 14 weeks

Secondary Outcomes (1)

  • Change from baseline in the proportion of the Japanese version of the K6 whose total score is less than nine at 14 weeks.

    Baseline, 10 weeks, 14 weeks

Other Outcomes (6)

  • Change from baseline in the total score of the Japanese vesion of the Link's stigma scale

    Baseline, 10 weeks, 14 weeks

  • Change from baseline in the total score of state anxiety of the Japanese version of the STAI

    Baseline, 10 weeks, 14 weeks

  • Change from baseline in the total score of the short version of the Japanese version of the Zarit Burden Interview (J-ZBI-8).

    Baseline, 10 weeks, 14 weeks

  • +3 more other outcomes

Study Arms (2)

Strengths-based family psychoeducation

EXPERIMENTAL

Family psychoeducation in addition to treatment as usual

Behavioral: Strengths-based family psychoeducation

Waiting list

NO INTERVENTION

Treatment as usual

Interventions

Strengths-based family psychoeducationBEHAVIORAL

Family psychoeducation in a group setting is performed every two weeks for eight weeks.

Strengths-based family psychoeducation

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kusunokikai Kusunoki Mental Hospital

Nagoya, Aichi-ken, 462-0011, Japan

Location

Shiseikai Yagoto Hospital

Nagoya, Aichi-ken, 468-0073, Japan

Location

Kyouseikai Minamichita Hospital

Nagoya, Aichi-ken, 470-3411, Japan

Location

Kenseikai Toyota-nishi Hospital

Toyota, Aichi-ken, 470-0344, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31477061DERIVED

MeSH Terms

Conditions

Stress, PsychologicalPsychotic Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Nao Shiraishi, MD

    Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

JP(4)