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Psychological StressesNCT01731977

Strengths-Based Family Psychoeducation for Youth Psychosis

A study testing Strengths-based family psychoeducation in people with Psychological Stresses, run by Nagoya City University at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Psychological Stresses
What is being tested?
Strengths-based family psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
4 sitesJapan
Study dates
Jul 2012to Jan 2016
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Japan4 sites
  • Kusunokikai Kusunoki Mental Hospital

    Nagoya, Aichi-ken, 462-0011

  • Shiseikai Yagoto Hospital

    Nagoya, Aichi-ken, 468-0073

  • Kyouseikai Minamichita Hospital

    Nagoya, Aichi-ken, 470-3411

  • Kenseikai Toyota-nishi Hospital

    Toyota, Aichi-ken, 470-0344

Other trials in Japan

About this study

Official title: Effectiveness of the Strengths-Based Family Psychoeducation for Youth Psychosis: Randomized Controlled Trial

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.

Read the 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.

Being tested
Strengths-based family psychoeducation
Keywords
Psychotherapy, Psychotic disorders, Caregiver
Medical subject headings
Stress, Psychological, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strengths-based family psychoeducationBehavioural

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

Study groups in NCT01731977
Study groupRoleWhat they receive
Strengths-based family psychoeducationExperimentalFamily psychoeducation in addition to treatment as usual
Receives: Behavioral: Strengths-based family psychoeducation
Waiting listNo interventionTreatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 10 weeks, 14 weeks

Secondary outcomes (1)
  1. 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.

    Measured: Baseline, 10 weeks, 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01731977
Sponsor's protocol ID
NCU-708
Other IDs
No. 29
Status last verified
Jan 2016
First submitted
18 Nov 2012
Last updated
5 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31477061

Questions about this trial

What is this clinical trial studying?

A study testing Strengths-based family psychoeducation in people with Psychological Stresses, run by Nagoya City University at 4 sites in Japan.

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 9 inclusion and 6 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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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?

Change from baseline in the total score of trait anxiety of the Japanese version of the STAI at 14 weeks (time frame: Baseline, 10 weeks, 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01731977, which also lists 1 linked publication.

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 5 Jan 2016.

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