MAPS Group Therapy Model for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Effect of Psychoeducational Group Therapy Model for Bipolar Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152034
• Other study ID #: MMH-I-S-662
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: April 7, 2015
• Start date: July 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2015
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Interventional

Clinical 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. 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Suicide

Intervention

Behavioral:
• psychoeducation group therapy
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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 3 months for up to 12 months after enrollment	Yes
Secondary	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.	every 3 months for up to 12 months after enrollment	Yes
Secondary	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.	every 3 months for up to 12 months after enrollment	Yes
Secondary	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.	every 3 months for up to 12 months after enrollment	Yes
Secondary	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.	every 3 months for up to 12 months after enrollment	Yes
Secondary	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.	every 3 months for up to 12 months after enrollment	Yes
Secondary	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.	every 3 months for up to 12 months after enrollment	Yes