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Community-based multi-site randomized controlled trial of behavioral activation for community dwelling individuals with chronic and severe mental disorders

Development of a novel psychosocial rehabilitation training program for negative symptoms of schizophrenia and its efficacy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0004098
Enrollment
200
Registered
2019-06-27
Start date
2015-11-18
Completion date
Unknown
Last updated
2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral : 1. Behavioral Activation (BA) Treatment BA consisted of semi-structured sessions to re-engage participants with potentially antidepressant activities, which were expected to result in inc
Lejuez et al., 2001), which was translated into Korean and modified considering Korean mental health setting and cultural differences. In particular, several adjustments were made to the original BA f

Sponsors

Korea University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: *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.).

Exclusion criteria

Exclusion criteria: *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.

Design outcomes

Primary

MeasureTime frame
[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

MeasureTime frame
[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

Countries

Korea, Republic of

Contacts

Public ContactEunbyeol Lee

Korea University

vivid30822@naver.com+82-2-3290-1676

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 23, 2026