Community-based multi-site randomized controlled trial of behavioral activation for community dwelling individuals with chronic and severe mental disorders
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004098
- Lead Sponsor
- Korea University
- Brief Summary
BA was found to be well accepted by clients, evidenced by low drop-out rates (i.e., 15% for schizophrenia, 25% for depression). As for the patients with schizophrenia, BA+TAU group in community mental health settings was revealed to be more effective than TAU-only group to reduce negative symptom severity, especially motivation and pleasure sub-domain. As for the community dwelling individuals with depressive disorders, BA+TAU was found to be more effective than TAU-only to decrease self-reported and clinician-rated depressive symptom severity and increase behavioral activation level. Also, depressive participants with more severe depressive symptoms (i.e., patients whose scores on the pre-treatment HRSD were 20 or more) attained more treatment effects from the addition of BA to TAU. Lastly, enhancement in behavioral activation levels was significantly associated with improvements in depression severity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 159
*Schizophrenia
Participants consisted of individuals who either met criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-?). DSM-? diagnoses were confirmed based on the Structured Clinical Interview for the DSM-? Axis I Disorders (SCID-I). All patients had been stably prescribed psychotropic medications for at least the previous 3 months.
*Depressive Disorders
Participants consisted of individuals between the ages of 18 and 80 years who either met criteria for major depressive disorder or dysthymic disorder according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-?). DSM-? diagnoses were confirmed based on either the Structured Clinical Interview for the DSM-? Axis I Disorders (SCID-I) or the Mini-International Neuropsychiatric Interview (M.I.N.I.).
*Schizophrenia
Participants were excluded if they had a history of organic brain syndrome, seizures, or traumatic brain injury. Additional exclusion criteria consisted of current comorbid disorders such as mental retardation, or current alcohol or other substance abuse/dependence, or risk of self-harming or homicide.
*Depressive Disorders
Participants were excluded if they had a lifetime diagnosis of stroke, brain injury, or mental retardation. Additional exclusion criteria consisted of suicidal risk, history of neurological diseases or sensory deficits, diagnosis of alcohol or other substance use disorders, or presence of other severe medical illnesses hindering research participation.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Schizophrenia] Negative symptoms: Positive and Negative Syndrome Scale (PANSS), Brief Negative Symptom Scale (BNSS), Clinical Assessment Interview for Negative Symptoms (CAINS) / [Depressive Disorders] Depressive symptoms: Hamilton Rating Scale for Depression (HRSD), Center for Epidemiologic Studies Depression Scale (CES-D)
- Secondary Outcome Measures
Name Time Method [Schizophrenia] Motivation level: Motivation and Pleasure Scale-Self Rating items (MAP-SR), General functioning: Quality of Life (QLS) / [Depressive Disorders] Behavioral Activation for Depression Scale (BADS), General functioning: Sheehan Disability Scale (SDS), Social and Occupational Functioning Assessment Scale (SOFAS);[Schizophrenia & Depressive Disorders] Neurocognitive functioning: 1) Attention & processing speed: Trail Making Test A (TMT-A), The Wechsler Adult Intelligent Scale-Fourth Edition (WAIS-IV) Coding subtest, 2) Working memory: The Wechsler Adult Intelligent Scale-Fourth Edition (WAIS-IV) Digit Span subtest, 3) Recent memory and verbal learning: Auditory Verbal Learning Test (AVLT), 4) Executive functioning: Trail Making Test B (TMT-B), 5) Premorbid IQ estimates: The Wechsler Adult Intelligent Scale-Fourth Edition (WAIS-IV) information subtest