A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression
- Conditions
- Depression Disorders
- Registration Number
- NCT06975098
- Lead Sponsor
- Chung Shan Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 11
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Canadian Occupational Performance Measure (baseline) baseline 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 (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-up 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.
Occupational balance (baseline) baseline 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.
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.
Occupational balance (follow-up) 1-month follow-up 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.
Occupational questionnaire (baseline) baseline 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 (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-up 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.
Role checklist (baseline) baseline 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.
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.
Role checklist (follow-up) 1-month follow-up 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.
- Secondary Outcome Measures
Name Time Method Quality of life (baseline) baseline 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 (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-up 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.
Depression (baseline) baseline 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 (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-up 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.
Trial Locations
- Locations (1)
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan