Chung Shan Medical University Hospital
Taichung, Taiwan
NCT Number: NCT06975098
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Taichung, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Chung Shan Medical University
Other
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