Clinical trial NCT06975098: A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression
Official title: A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Disorders
Keywords: depression
life balance
individualized intervention
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical intervention study is to enhance life balance in community-dwelling individuals with depression. The main question it aims to answer is:

Can an individualized life balance intervention, combining group sessions and telephone support, effectively improve life balance, time management, functional roles, quality of life, and reduce depression severity in individuals with depression?

Participants will:

Complete baseline assessments including demographics, illness-related information, and the Canadian Occupational Performance Measure (COPM).

Participate in four weekly, two-hour group sessions tailored to their individual needs identified through the COPM assessment.

Receive telephone support 1-3 days before each group session. Complete post-intervention assessments immediately after the four-week program and again one month later.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with depression by a psychiatrist.
* Assessed by a psychiatrist to be in a non-acute phase, approximately 4-8 weeks or more post-onset.
* Adults aged 20 or above with independent behavioral capacity.
* Literate, with basic cognitive function.

Exclusion Criteria:

* Diagnosis of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance-related and addictive disorders, neurodevelopmental disorders, neurocognitive disorders, or substance/medication-induced depressive disorders.
* Significant physical illnesses requiring active and long-term treatment, such as cancer, cerebrovascular disease (stroke), spinal cord injury, congenital or genetic diseases, chronic renal failure, systemic autoimmune diseases, or burns.
* Lack of willingness to participate in the study.

Primary outcomes:
measure: Canadian Occupational Performance Measure (baseline)
timeFrame: baseline
measure: Canadian Occupational Performance Measure (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Canadian Occupational Performance Measure (follow-up)
timeFrame: 1-month follow-up
measure: Occupational balance (baseline)
timeFrame: baseline
measure: Occupational balance (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Occupational balance (follow-up)
timeFrame: 1-month follow-up
measure: Occupational questionnaire (baseline)
timeFrame: baseline
measure: Occupational questionnaire (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Occupational questionnaire (follow-up)
timeFrame: 1-month follow-up
measure: Role checklist (baseline)
timeFrame: baseline
measure: Role checklist (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Role checklist (follow-up)
timeFrame: 1-month follow-up
Secondary outcomes:
measure: Quality of life (baseline)
timeFrame: baseline
measure: Quality of life (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Quality of life (follow-up)
timeFrame: 1-month follow-up
measure: Depression (baseline)
timeFrame: baseline
measure: Depression (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Depression (follow-up)
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
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