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MAPS Group Therapy Model for Bipolar Disorder

Primary Purpose

Bipolar Disorder, Suicide

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
psychoeducation group therapy
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, psychosocial intervention, group therapy, relapse prevention, parasuicide, Recurrence, hospitalization, Medication adherence, Self-Injurious Behavior, Quality of Life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Psychoeducation group therapy

Treat as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 22, 2010
Last Updated
April 7, 2015
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01152034
Brief Title
MAPS Group Therapy Model for Bipolar Disorder
Official Title
Effect of Psychoeducational Group Therapy Model for Bipolar Disorder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Suicide
Keywords
Bipolar disorder, psychosocial intervention, group therapy, relapse prevention, parasuicide, Recurrence, hospitalization, Medication adherence, Self-Injurious Behavior, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation group therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treat as Usual
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
psychoeducation group therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The main outcome measures are time to recurrence a new acute bipolar episode
Description
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.
Time Frame
every 3 months for up to 12 months after enrollment
Secondary Outcome Measure Information:
Title
Number of recurrences
Description
The number of recurrences, separating for type of episode (manic, hypomanic, mixed or depressive) will also be recorded as a secondary outcome measure.
Time Frame
every 3 months for up to 12 months after enrollment
Title
Time spent ill
Description
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.
Time Frame
every 3 months for up to 12 months after enrollment
Title
Psychiatric outpatient adherence and drug compliance
Description
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.
Time Frame
every 3 months for up to 12 months after enrollment
Title
Numbers and time of emergency use and hospitalization
Description
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.
Time Frame
every 3 months for up to 12 months after enrollment
Title
Suicidal ideation and number of suicidal attempt
Description
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.
Time Frame
every 3 months for up to 12 months after enrollment
Title
The life quality of bipolar patients
Description
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.
Time Frame
every 3 months for up to 12 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

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MAPS Group Therapy Model for Bipolar Disorder

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