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A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression

A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06975098
Enrollment
11
Registered
2025-05-16
Start date
2024-09-23
Completion date
2025-06-30
Last updated
2025-08-13

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

Conditions

Depression Disorders

Keywords

depression, life balance, individualized intervention

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.

Interventions

OTHERLife balance intervention group program

Life balance intervention group program is a four-week group intervention program for individuals with depression, with sessions lasting two hours each week. The program will address life balance issues such as daily scheduling, time management, stress coping, emotional regulation, and social participation, and will be tailored to individual patient needs. Through group discussions and practical exercises, participants will learn to apply these skills in their daily lives. Telephone support will be provided during the intervention period to offer emotional support and enhance participation rates.

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Role checklist (follow-up)1-month follow-upRole checklist is used to assess the major roles that organize participant's daily life and the value of each role. The roles included the student, worker, volunteer, caregiver, home maintainer, friend, family member, religious participant, hobbyist, and participant in organizations. A higher number of roles means participating more roles in daily life. A higher score in the value of roles means more productive behaviors participants needed or desired.
Occupational balance (follow-up)1-month follow-upOccupational Balance Questionnaire 11-Chinese version (OBQ11-C) is a 11-item questionnaire with a four point rating scale for each item (from 0 to 3) by the level of agreemtent with each of the affirmations. The OBQ11-C is used to measure the perception of current occupational balance in daily life. The total score is ranged from 0 to 33. A higher score indicates a greater occupational balance.
Occupational questionnaire (baseline)baselineOccupational questionnaire (OQ) is used to record daily occupations on 30-minute interval for a typical day. Each activity need to be classified as work, activity of daily living, recreation or rest and be rated for the competence, value, and interest using a five point rating scale. It indicates how well the participants do the activity, how important the activity is as well as how enjoyable the activity is. The higher score means better satisfaction, value and enjoyment of activity that the participant did.
Occupational questionnaire (post-intervention)post-intervention (up to 4 weeks)Occupational questionnaire (OQ) is used to record daily occupations on 30-minute interval for a typical day. Each activity need to be classified as work, activity of daily living, recreation or rest and be rated for the competence, value, and interest using a five point rating scale. It indicates how well the participants do the activity, how important the activity is as well as how enjoyable the activity is. The higher score means better satisfaction, value and enjoyment of activity that the participant did.
Occupational questionnaire (follow-up)1-month follow-upOccupational questionnaire (OQ) is used to record daily occupations on 30-minute interval for a typical day. Each activity need to be classified as work, activity of daily living, recreation or rest and be rated for the competence, value, and interest using a five point rating scale. It indicates how well the participants do the activity, how important the activity is as well as how enjoyable the activity is. The higher score means better satisfaction, value and enjoyment of activity that the participant did.
Role checklist (baseline)baselineRole checklist is used to assess the major roles that organize participant's daily life and the value of each role. The roles included the student, worker, volunteer, caregiver, home maintainer, friend, family member, religious participant, hobbyist, and participant in organizations. A higher number of roles means participating more roles in daily life. A higher score in the value of roles means more productive behaviors participants needed or desired.
Role checklist (post-intervention)post-intervention (up to 4 weeks)Role checklist is used to assess the major roles that organize participant's daily life and the value of each role. The roles included the student, worker, volunteer, caregiver, home maintainer, friend, family member, religious participant, hobbyist, and participant in organizations. A higher number of roles means participating more roles in daily life. A higher score in the value of roles means more productive behaviors participants needed or desired.
Canadian Occupational Performance Measure (baseline)baselineThe Canadian Occupational Performance Measure (COPM) is a client-centered assessment tool used to evaluate changes in the performance and satisfaction of an individual's perceived occupational performance problems over time. When occupational performance is difficult to quantify, the COPM serves as an outcome measure. Therapists conduct a semi-structured interview with the individual to identify their most important occupational performance problems, and then rate the importance, performance, and satisfaction of each problem on a scale of 1 to 10. Higher scores indicate greater importance, performance, and satisfaction. During reassessment, individuals re-rate these occupational performance problems. A change of 2 points or more between initial and subsequent scores is considered clinically significant.
Canadian Occupational Performance Measure (post-intervention)post-intervention (up to 4 weeks)The Canadian Occupational Performance Measure (COPM) is a client-centered assessment tool used to evaluate changes in the performance and satisfaction of an individual's perceived occupational performance problems over time. When occupational performance is difficult to quantify, the COPM serves as an outcome measure. Therapists conduct a semi-structured interview with the individual to identify their most important occupational performance problems, and then rate the importance, performance, and satisfaction of each problem on a scale of 1 to 10. Higher scores indicate greater importance, performance, and satisfaction. During reassessment, individuals re-rate these occupational performance problems. A change of 2 points or more between initial and subsequent scores is considered clinically significant.
Canadian Occupational Performance Measure (follow-up)1-month follow-upThe Canadian Occupational Performance Measure (COPM) is a client-centered assessment tool used to evaluate changes in the performance and satisfaction of an individual's perceived occupational performance problems over time. When occupational performance is difficult to quantify, the COPM serves as an outcome measure. Therapists conduct a semi-structured interview with the individual to identify their most important occupational performance problems, and then rate the importance, performance, and satisfaction of each problem on a scale of 1 to 10. Higher scores indicate greater importance, performance, and satisfaction. During reassessment, individuals re-rate these occupational performance problems. A change of 2 points or more between initial and subsequent scores is considered clinically significant.
Occupational balance (baseline)baselineOccupational Balance Questionnaire 11-Chinese version (OBQ11-C) is a 11-item questionnaire with a four point rating scale for each item (from 0 to 3) by the level of agreemtent with each of the affirmations. The OBQ11-C is used to measure the perception of current occupational balance in daily life. The total score is ranged from 0 to 33. A higher score indicates a greater occupational balance.
Occupational balance (post-intervention)post-intervention (up to 4 weeks)Occupational Balance Questionnaire 11-Chinese version (OBQ11-C) is a 11-item questionnaire with a four point rating scale for each item (from 0 to 3) by the level of agreemtent with each of the affirmations. The OBQ11-C is used to measure the perception of current occupational balance in daily life. The total score is ranged from 0 to 33. A higher score indicates a greater occupational balance.

Secondary

MeasureTime frameDescription
Quality of life (post-intervention)post-intervention (up to 4 weeks)The World Health Organization Quality of Life Questionnaire- BREF Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire with a five point rating scale for each item (from 1 to 5). There are four domains in WHOQOL-BREF-TW, including physical health, psychological health, social relationships, and environment. A higher score indicates a higher quality of life.
Quality of life (follow-up)1-month follow-upThe World Health Organization Quality of Life Questionnaire- BREF Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire with a five point rating scale for each item (from 1 to 5). There are four domains in WHOQOL-BREF-TW, including physical health, psychological health, social relationships, and environment. A higher score indicates a higher quality of life.
Depression (baseline)baselineBeck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.
Depression (post-intervention)post-intervention (up to 4 weeks)Beck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.
Depression (follow-up)1-month follow-upBeck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.
Quality of life (baseline)baselineThe World Health Organization Quality of Life Questionnaire- BREF Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire with a five point rating scale for each item (from 1 to 5). There are four domains in WHOQOL-BREF-TW, including physical health, psychological health, social relationships, and environment. A higher score indicates a higher quality of life.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026