MAPS Group Therapy Model for Bipolar Disorder

NCT ID: NCT01152034

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-04-30

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".

Conditions

Bipolar Disorder; Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psychoeducation group therapy

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.

Group Type: EXPERIMENTAL

psychoeducation group therapy

Intervention Type: BEHAVIORAL

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.

Treat as Usual

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.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen-Ju Lin

senior visiting staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

MMH-I-S-662

Identifier Type: -

Identifier Source: org_study_id