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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Psychological Stresses
- 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 group | Role | What they receive |
|---|---|---|
| Strengths-based family psychoeducation | Experimental | Family psychoeducation in addition to treatment as usual Receives: Behavioral: Strengths-based family psychoeducation |
| Waiting list | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted22 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological StressesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Collaborators
- Aichi Health Promotion Foundation
- Responsible party
- Principal investigator, Nao Shiraishi, Nagoya City University
- Investigators
- Nao Shiraishi, MD, Principal investigator, Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Strengths-Based Family Psychoeducation for Youth Psychosis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01731977
- Acronym / sponsor ID
- NCU-708
- Conditions
- Psychological Stresses
- Keywords
- Psychotherapy, Psychotic disorders, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Collaborators
- Aichi Health Promotion Foundation
- Study start
- Jul 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengths-based family psychoeducation | Experimental | Behavioral: Strengths-based family psychoeducationFamily psychoeducation in addition to treatment as usual |
| Waiting list | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient
- The family
Key exclusion criteria (6 listed)
- The patient
- The family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengths-based family psychoeducationFamily psychoeducation in a group setting is performed every two weeks for eight weeks. | Behavioural | Strengths-based family psychoeducation |
Primary outcome
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
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.
1 secondary outcome
Change from baseline in the proportion of the Japanese version of the K6 whose total score is less than nine at 14 weeks.
Time frame: Baseline, 10 weeks, 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Derived from this study: PubMed 31477061Shiraishi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nao Shiraishi, MD principal investigator
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
4 sites in 1 country: see every site and its status.
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.