Clinical trial NCT04020289: A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
Official title: A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: bipolar disorder
depression
manic
illness perception
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment as usual (TAU); and Psychoeducational Program "BalancingMySwing"
Primary purpose: TREATMENT

Brief summary: The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for BD, and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.

Detailed description: The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for bipolar disorders (BD), and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.

During the first 2 years, a randomized controlled trial was conducted. Patients diagnosed with BD were recruited and 104 patients were randomly assigned to treatment as usual (TAU) or to 8 BMS sessions. A battery of three outcome indicators-social rhythm, illness perception, and symptom severity-were used to examine the effects of the two groups at baseline, after intervention, and every 3 months until half year. In addition, a pre- and post-test quasi-experimental study combined with qualitative design was used to assess the translational feasibility of BMS and to explore related barriers and facilitators of implementing BMS in clinical settings in the third year. Nurses from 4 Hospitals received the BMS training, and patients with BD received the BMS translated in practice were recruited.

Eligibility criteria: Inclusion Criteria:

* Had a DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-IV) diagnosis of BP-I or II confirmed through the interviews using the Chinese version of the Modified Schedule of Affective Disorder and Schizophrenia-Lifetime.
* Able to speak and read Taiwanese or Taiwanese Mandarin Chinese
* Had signed a written consent form
* Agreed to accept the following medication therapy during the study: a mood stabilizer (valproic acid or lithium salts), an antidepressant, second generation antipsychotics, anxiolytics (lorazepam \[\< 8 mg/day\]), and medicine to counteract side effects: extrapyramidal symptoms, tachycardia, and involuntary movement of smooth muscles in the gastrointestinal tract, urinary tract, lungs, etc.

Exclusion Criteria:

* Required immediate hospitalization
* Had any comorbidity with substance abuse or were current alcohol or drug abusers, or had been in the previous year
* Had been diagnosed with an organic psychosis, a neurodegenerative disease, a personality disorder, or impaired cognitive abilities

Primary outcomes:
measure: Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
timeFrame: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
measure: Changes from Baseline Illness Perception through Study Completion, at the 3rd and the 6th month after study completion
timeFrame: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
measure: Changes from Baseline Manic Symptom through Study Completion, at the 3rd and the 6th month after study completion
timeFrame: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
measure: Changes from Baseline Depressive Symptom through Study Completion, at the 3rd and the 6th month after study completion
timeFrame: At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cheng Kung University
name: Esther C Lin
role: PRINCIPAL_INVESTIGATOR
References: