Bipolar DisorderNCT01152034
MAPS Group Therapy Model for Bipolar Disorder
A study testing psychoeducation group therapy in people with Bipolar Disorder and Suicide, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other adjuvant clinical treatment and develop the instruments for evaluating the severity of bipolar symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Suicide
- What is being tested?
- psychoeducation group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2009to Apr 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bipolar disorder outpatients in remission, defined as Young Mania Rating Scale score < 6, Hamiltone Depression Rating Scale-17 < 8
- age 18 to 65 years old
- speaking Mandarin
- agree to sign the inform consent
Who cannot join
- Those who were hard to communicate such as mental retardation, hearing impairment and etc
- with acute psychotic feature
- with severe physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Psychoeducational Group Therapy Model for Bipolar Disorder Patients
This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other adjuvant clinical treatment and develop the instruments for evaluating the severity of bipolar symptoms. The investigators insist to provide the psychosocial intervention for bipolar patients in the general hospital and offer appropriative adjuvant intervention except current psychiatric biological treatment.
This study is a one-year project. First, the investigators like to translate the Depression, Anxiety and Stress Scale (DASS) and the Altman Self-Rating Scale for Mania (ASRM) to Chinese and finish the reliability and validity study. Second, the investigators would like to develop the MAPS group therapy to enhance bipolar patients' insight, increased life quality and decrease suicidal ideation. This study is a case control study. All cases recruit from the psychiatric outpatient department of one medical center. The inclusion criteria are diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. The excluded criteria are hard to communicate, with acute psychiatric feature and severe physical illness. The investigators plan to hold the MAPS group three times and predetermine to recruit totally 30 patients as the case group. As to the control group, the investigators also recruit from the psychiatric outpatient department and those who treat as usual by control their gender, age and the same diagnosis as bipolar disorder. The only one different factor between the case group and the control group was attending the MAPS group therapy or not. In MAPS group therapy, two facilitators work with ten clients with twelve weekly sessions and three monthly booster sessions. Self-report rating scales (DASS and ASRM) are completed at the beginning of each session. The investigators use DASS and ASRM to evaluate the severity of bipolar symptoms; BSS for suicidal ideation; SF-36 for life quality. The hypothesis is "patients attended to MAPS group therapy have better symptoms control, lower suicidal ideation, better life quality and less use emergency department or admissions than those who didn't attend the group therapy".
- Conditions
- Bipolar Disorder, Suicide
- Being tested
- psychoeducation group therapy
- Keywords
- Bipolar disorder, psychosocial intervention, group therapy, relapse prevention, parasuicide, Recurrence, hospitalization, Medication adherence, Self-Injurious Behavior, Quality of Life
- Medical subject headings
- Bipolar Disorder, Suicide, Suicide, Attempted, Recurrence, Medication Adherence, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducation group therapyBehavioural
This program consists of 15 sessions of closed group, with each session lasting 120 minutes, each aims at improving four main issues: illness awareness, early detection of prodromal symptoms and recurrences, treatment adherence, and lifestyle regularity. The program will be in groups of 6-12, conducted by two experienced therapists. The structure of each session consists of 30-40 minutes talk on the topic of the day, followed by an exercise related to the issue and a discussion.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation group therapy | Experimental | The structured group program comprised of an initial block of 12 weekly sessions with three additional monthly booster sessions, designed to support participants in the application of knowledge and skills to everyday life situations. All participants also received standard psychiatric care as well. Receives: Behavioral: psychoeducation group therapy |
| Treat as Usual | Placebo comparator | Patients who were assigned to the control group received standard psychiatric care and standard pharmacological treatment without group-based psychosocial intervention. Weekly phone calls to the control group over the initial 12 weeks were controlled for any extra contact time with researchers outside of the structured intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measures are time to recurrence a new acute bipolar episode
This is defined as the time (days) elapsed between baseline and the emergence of a new acute episode according to DSM-IV criteria and scores above or equal to 20 on the YMRS for manic recurrence; above or equal to 12 for hypomanic recurrence; above or equal to 17 on the HRSD-17 for depressive recurrence; and above or equal to 20 on the YMRS and 12 on the HRSD-17 for mixed recurrence.
Measured: every 3 months for up to 12 months after enrollment
Secondary outcomes (6)
Number of recurrences
The number of recurrences, separating for type of episode (manic, hypomanic, mixed or depressive) will also be recorded as a secondary outcome measure.
Measured: every 3 months for up to 12 months after enrollment
Time spent ill
Another secondary outcome measure is time spent ill. The investigators obtain this data by prospectively registering the number of days that a participant fulfilled criteria for a specific episode.
Measured: every 3 months for up to 12 months after enrollment
Psychiatric outpatient adherence and drug compliance
The medication compliance questionnaire reported compliance with any prescribed mood stablizers.(Lam DH, et al. 2000, 2005) Respondents had a choice of noting whether the patient in the past month had (1) never missed taking their medication, (2) missed taking it once or twice, (3) missed taking it between three to seven times, (4) missed taking it more than seven times, or (5) stopped taking it altogether.
Measured: every 3 months for up to 12 months after enrollment
Numbers and time of emergency use and hospitalization
The number of hospitalizations, reasons for admission and total number of days that the participant remained hospitalized will also be recorded during follow-up period.
Measured: every 3 months for up to 12 months after enrollment
Suicidal ideation and number of suicidal attempt
The Chinese version of Scale for Suicide Ideation had been translated and the excellent psychometric properties for measuring suicidal ideation in Chinese populations were done (Zhang and Brown, 2007). The BSS and the suicidal attempts will be re-assessed every 3 months or whenever a new episode was suspected by the psychiatrist in charge of the participant.
Measured: every 3 months for up to 12 months after enrollment
The life quality of bipolar patients
This SF-36 Taiwan standard version was developed in 1996 following the protocol by the International Quality of Life Assessment (IQOLA) Project. The protocol includes forward and backward translation, focus group discussion, pilot testing, and extensive psychometric analysis of the translation. (Fuh JL et al, 2000; Chang DF,et al, 2000).The SF-36 Taiwan standard version will be also repeated every 3 months or whenever a new episode was suspected by the psychiatrist in charge of the participant.
Measured: every 3 months for up to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen-Ju Lin, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152034
- Sponsor's protocol ID
- MMH-I-S-662
- Status last verified
- Apr 2015
- First submitted
- 22 Jun 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychoeducational Group Therapy Model for Bipolar Disorder Patients
- ClinicalTrials.gov ID
- NCT01152034
- Acronym / sponsor ID
- MMH-I-S-662
- Conditions
- Bipolar Disorder, Suicide
- Keywords
- Bipolar disorder, psychosocial intervention, group therapy, relapse prevention, parasuicide, Recurrence, hospitalization, Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Jun 2010 (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.
This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other adjuvant clinical treatment and develop the instruments for evaluating the severity of bipolar symptoms. The investigators insist to provide the psychosocial intervention for bipolar patients in the general hospital and offer appropriative adjuvant intervention except current psychiatric biological treatment.
This study is a one-year project. First, the investigators like to translate the Depression, Anxiety and Stress Scale (DASS) and the Altman Self-Rating Scale for Mania (ASRM) to Chinese and finish the reliability and validity study. Second, the investigators would like to develop the MAPS group therapy to enhance bipolar patients' insight, increased life quality and decrease suicidal ideation. This study is a case control study. All cases recruit from the psychiatric outpatient department of one medical center. The inclusion criteria are diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. The excluded criteria are hard to communicate, with acute psychiatric feature and severe physical illness. The investigators plan to hold the MAPS group three times and predetermine to recruit totally 30 patients as the case group. As to the control group, the investigators also recruit from the psychiatric outpatient department and those who treat as usual by control their gender, age and the same diagnosis as bipolar disorder. The only one different factor between the case group and the control group was attending the MAPS group therapy or not. In MAPS group therapy, two facilitators work with ten clients with twelve weekly sessions and three monthly booster sessions. Self-report rating scales (DASS and ASRM) are completed at the beginning of each session. The investigators use DASS and ASRM to evaluate the severity of bipolar symptoms; BSS for suicidal ideation; SF-36 for life quality. The hypothesis is "patients attended to MAPS group therapy have better symptoms control, lower suicidal ideation, better life quality and less use emergency department or admissions than those who didn't attend the group therapy".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation group therapy | Experimental | Behavioral: psychoeducation group therapyThe structured group program comprised of an initial block of 12 weekly sessions with three additional monthly booster sessions, designed to support participants in the application of knowledge and skills to everyday life situations. All participants also received standard psychiatric care as well. |
| Treat as Usual | Placebo comparator | –Patients who were assigned to the control group received standard psychiatric care and standard pharmacological treatment without group-based psychosocial intervention. Weekly phone calls to the control group over the initial 12 weeks were controlled for any extra contact time with researchers outside of the structured intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- bipolar disorder outpatients in remission, defined as Young Mania Rating Scale score < 6, Hamiltone Depression Rating Scale-17 < 8
- age 18 to 65 years old
- speaking Mandarin
- agree to sign the inform consent
Key exclusion criteria (3 listed)
- Those who were hard to communicate such as mental retardation, hearing impairment and etc
- with acute psychotic feature
- with severe physical illness
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 |
|---|---|---|
| psychoeducation group therapyThis program consists of 15 sessions of closed group, with each session lasting 120 minutes, each aims at improving four main issues: illness awareness, early detection of prodromal symptoms and recurrences, treatment adherence, and lifestyle regularity. The program will be in groups of 6-12, conducted by two experienced therapists. The structure of each session consists of 30-40 minutes talk on the topic of the day, followed by an exercise related to the issue and a discussion. | Behavioural | Psychoeducation group therapy |
Primary outcome
The main outcome measures are time to recurrence a new acute bipolar episode
Time frame: every 3 months for up to 12 months after enrollment
This is defined as the time (days) elapsed between baseline and the emergence of a new acute episode according to DSM-IV criteria and scores above or equal to 20 on the YMRS for manic recurrence; above or equal to 12 for hypomanic recurrence; above or equal to 17 on the HRSD-17 for depressive recurrence; and above or equal to 20 on the YMRS and 12 on the HRSD-17 for mixed recurrence.
6 secondary outcomes
Number of recurrences
Time frame: every 3 months for up to 12 months after enrollment
Time spent ill
Time frame: every 3 months for up to 12 months after enrollment
Psychiatric outpatient adherence and drug compliance
Time frame: every 3 months for up to 12 months after enrollment
Numbers and time of emergency use and hospitalization
Time frame: every 3 months for up to 12 months after enrollment
Suicidal ideation and number of suicidal attempt
Time frame: every 3 months for up to 12 months after enrollment
The life quality of bipolar patients
Time frame: every 3 months for up to 12 months after enrollment
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 8 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation group therapy in people with Bipolar Disorder and Suicide, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. Some participants in this study may receive a placebo. 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?
The main outcome measures are time to recurrence a new acute bipolar episode (time frame: every 3 months for up to 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015.