Clinical trial NCT01152034: MAPS Group Therapy Model for Bipolar Disorder
Official title: Effect of Psychoeducational Group Therapy Model for Bipolar Disorder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Suicide
Keywords: Bipolar disorder
psychosocial intervention
group therapy
relapse prevention
parasuicide
Recurrence
hospitalization
Medication adherence
Self-Injurious Behavior
Quality of Life
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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".


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Those who were hard to communicate such as mental retardation, hearing impairment and etc
* with acute psychotic feature
* with severe physical illness

Primary outcomes:
measure: The main outcome measures are time to recurrence a new acute bipolar episode
timeFrame: every 3 months for up to 12 months after enrollment
Secondary outcomes:
measure: Number of recurrences
timeFrame: every 3 months for up to 12 months after enrollment
measure: Time spent ill
timeFrame: every 3 months for up to 12 months after enrollment
measure: Psychiatric outpatient adherence and drug compliance
timeFrame: every 3 months for up to 12 months after enrollment
measure: Numbers and time of emergency use and hospitalization
timeFrame: every 3 months for up to 12 months after enrollment
measure: Suicidal ideation and number of suicidal attempt
timeFrame: every 3 months for up to 12 months after enrollment
measure: The life quality of bipolar patients
timeFrame: every 3 months for up to 12 months after enrollment
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References: