Depression DisordersNCT06975098
A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression
A study testing Life balance intervention group program in people with Depression Disorders, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depression Disorders
- What is being tested?
- Life balance intervention group program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Depression Disorders
- Being tested
- Life balance intervention group program
- Keywords
- depression, life balance, individualized intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life balance intervention group programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Life balance intervention group | Experimental | Intervention:
A four-week individualized life balance intervention. The intervention combines weekly two-hour group sessions with telephone support provided 1-3 days prior to each session.
Group session content is tailored to individual participant needs, identified through the Canadian Occupational Performance Measure (COPM) assessment. Receives: Other: Life balance intervention group program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (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.
Measured: baseline
Canadian Occupational Performance Measure (post-intervention)
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.
Measured: post-intervention (up to 4 weeks)
Canadian Occupational Performance Measure (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.
Measured: 1-month follow-up
Occupational balance (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.
Measured: baseline
Occupational balance (post-intervention)
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.
Measured: post-intervention (up to 4 weeks)
Occupational balance (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.
Measured: 1-month follow-up
Occupational questionnaire (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.
Measured: baseline
Occupational questionnaire (post-intervention)
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.
Measured: post-intervention (up to 4 weeks)
Occupational questionnaire (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.
Measured: 1-month follow-up
Role checklist (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.
Measured: baseline
Role checklist (post-intervention)
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.
Measured: post-intervention (up to 4 weeks)
Role checklist (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.
Measured: 1-month follow-up
Secondary outcomes (6)
Quality of life (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.
Measured: baseline
Quality of life (post-intervention)
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.
Measured: post-intervention (up to 4 weeks)
Quality of life (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.
Measured: 1-month follow-up
Depression (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.
Measured: baseline
Depression (post-intervention)
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.
Measured: post-intervention (up to 4 weeks)
Depression (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.
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start23 Sep 2024
- Primary completion13 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Ling Chen, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975098
- Sponsor's protocol ID
- CS2-23222
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao G, Chung CW, Yu CF, Wang JD. Development and verification of validity and reliability of the WHOQOL-BREF Taiwan version. J Formos Med Assoc. 2002 May;101(5):342-51.
PubMed 12101852World Health Organization. (2017). Depression and Other Common Mental Disorders: Global Health Estimates. World Health Organization (Licence: CC BY-NC-SA 3.0 IGO). http://www.who.int/mental_health/management/depression/prevalence_global_health_estimates/en/
Wagman P, Hakansson C, Bjorklund A. Occupational balance as used in occupational therapy: a concept analysis. Scand J Occup Ther. 2012 Jul;19(4):322-7. doi: 10.3109/11038128.2011.596219. Epub 2011 Jul 25.
PubMed 21780985Wagman P, Hjarthag F, Hakansson C, Hedin K, Gunnarsson AB. Factors associated with higher occupational balance in people with anxiety and/or depression who require occupational therapy treatment. Scand J Occup Ther. 2021 Aug;28(6):426-432. doi: 10.1080/11038128.2019.1693626. Epub 2019 Dec 14.
PubMed 31838931Wagman P, Hakansson C. Introducing the Occupational Balance Questionnaire (OBQ). Scand J Occup Ther. 2014 May;21(3):227-31. doi: 10.3109/11038128.2014.900571. Epub 2014 Mar 21.
PubMed 24649971Uyeshiro Simon A, Collins CER. Lifestyle Redesign(R) for Chronic Pain Management: A Retrospective Clinical Efficacy Study. Am J Occup Ther. 2017 Jul/Aug;71(4):7104190040p1-7104190040p7. doi: 10.5014/ajot.2017.025502.
PubMed 28661383Smith NR, Kielhofner G, Watts JH. The relationships between volition, activity pattern, and life satisfaction in the elderly. Am J Occup Ther. 1986 Apr;40(4):278-83. doi: 10.5014/ajot.40.4.278.
PubMed 3963137Skjutar A, Schult ML, Christensson K, Mullersdorf M. Indicators of need for occupational therapy in patients with chronic pain: occupational therapists' focus groups. Occup Ther Int. 2010 Jun;17(2):93-103. doi: 10.1002/oti.282.
PubMed 19653210Shang, C. Y., Liao, S. C., & Lee, M. B. (2003). Trends of visiting rate of depressive outpatients in psychiatric clinic. Formosan Journal of Medicine, 7(4), 502-509. (in Chinese).
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
PubMed 17074942Pyatak E, King M, Vigen CLP, Salazar E, Diaz J, Schepens Niemiec SL, Blanchard J, Jordan K, Banerjee J, Shukla J. Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign(R) Occupational Therapy. Am J Occup Ther. 2019 Sep/Oct;73(5):7305185020p1-7305185020p12. doi: 10.5014/ajot.2019.037317.
PubMed 31484021Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
PubMed 34299957Mcmullen C, Liu L, Bulkley JE, Hornbrook MC, Wendel C, Grant M, Altschuler A, Temple LK, Krouse RS, Herrinton L. Participation in Activities Associated With Quality of Life for Long-Term Survivors of Rectal Cancer. Perm J. 2017;21:16-011. doi: 10.7812/TPP/16-011.
PubMed 28241904Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052Magnusson L, Hakansson C, Brandt S, Oberg M, Orban K. Occupational balance and sleep among women. Scand J Occup Ther. 2021 Nov;28(8):643-651. doi: 10.1080/11038128.2020.1721558. Epub 2020 Mar 18.
PubMed 32186421
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Journey to Balance: Development and Validation of Individualized Life Balance Intervention for Depression
- ClinicalTrials.gov ID
- NCT06975098
- Acronym / sponsor ID
- CS2-23222
- Conditions
- Depression Disorders
- Keywords
- depression, life balance, individualized intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Life balance intervention group | Experimental | Other: Life balance intervention group programIntervention: A four-week individualized life balance intervention. The intervention combines weekly two-hour group sessions with telephone support provided 1-3 days prior to each session. Group session content is tailored to individual participant needs, identified through the Canadian Occupational Performance Measure (COPM) assessment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life balance intervention group programLife 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. | Other | Life balance intervention group |
Primary outcome
Canadian Occupational Performance Measure (baseline)
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.
Canadian Occupational Performance Measure (post-intervention)
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.
Canadian Occupational Performance Measure (follow-up)
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.
Occupational balance (baseline)
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.
Occupational balance (post-intervention)
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.
Occupational balance (follow-up)
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.
Occupational questionnaire (baseline)
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.
Occupational questionnaire (post-intervention)
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.
Occupational questionnaire (follow-up)
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.
Role checklist (baseline)
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.
Role checklist (post-intervention)
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.
Role checklist (follow-up)
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.
6 secondary outcomes
Quality of life (baseline)
Time frame: baseline
Quality of life (post-intervention)
Time frame: post-intervention (up to 4 weeks)
Quality of life (follow-up)
Time frame: 1-month follow-up
Depression (baseline)
Time frame: baseline
Depression (post-intervention)
Time frame: post-intervention (up to 4 weeks)
Depression (follow-up)
Time frame: 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Results publication: PubMed 12101852Yao G, Chung CW, Yu CF, Wang JD. Development and verification of validity and reliability of the WHOQOL-BREF Taiwan version. J Formos Med Assoc. 2002 May;101(5):342-51.
- Results publicationWorld Health Organization. (2017). Depression and Other Common Mental Disorders: Global Health Estimates. World Health Organization (Licence: CC BY-NC-SA 3.0 IGO). http://www.who.int/mental_health/management/depression/prevalence_global_health_estimates/en/
- Results publication: PubMed 21780985Wagman P, Hakansson C, Bjorklund A. Occupational balance as used in occupational therapy: a concept analysis. Scand J Occup Ther. 2012 Jul;19(4):322-7. doi: 10.3109/11038128.2011.596219. Epub 2011 Jul 25.
- Results publication: PubMed 31838931Wagman P, Hjarthag F, Hakansson C, Hedin K, Gunnarsson AB. Factors associated with higher occupational balance in people with anxiety and/or depression who require occupational therapy treatment. Scand J Occup Ther. 2021 Aug;28(6):426-432. doi: 10.1080/11038128.2019.1693626. Epub 2019 Dec 14.
- Results publication: PubMed 24649971Wagman P, Hakansson C. Introducing the Occupational Balance Questionnaire (OBQ). Scand J Occup Ther. 2014 May;21(3):227-31. doi: 10.3109/11038128.2014.900571. Epub 2014 Mar 21.
- Results publication: PubMed 28661383Uyeshiro Simon A, Collins CER. Lifestyle Redesign(R) for Chronic Pain Management: A Retrospective Clinical Efficacy Study. Am J Occup Ther. 2017 Jul/Aug;71(4):7104190040p1-7104190040p7. doi: 10.5014/ajot.2017.025502.
- Results publication: PubMed 3963137Smith NR, Kielhofner G, Watts JH. The relationships between volition, activity pattern, and life satisfaction in the elderly. Am J Occup Ther. 1986 Apr;40(4):278-83. doi: 10.5014/ajot.40.4.278.
- Results publication: PubMed 19653210Skjutar A, Schult ML, Christensson K, Mullersdorf M. Indicators of need for occupational therapy in patients with chronic pain: occupational therapists' focus groups. Occup Ther Int. 2010 Jun;17(2):93-103. doi: 10.1002/oti.282.
- Results publicationShang, C. Y., Liao, S. C., & Lee, M. B. (2003). Trends of visiting rate of depressive outpatients in psychiatric clinic. Formosan Journal of Medicine, 7(4), 502-509. (in Chinese).
- Results publication: PubMed 17074942Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
- Results publication: PubMed 31484021Pyatak E, King M, Vigen CLP, Salazar E, Diaz J, Schepens Niemiec SL, Blanchard J, Jordan K, Banerjee J, Shukla J. Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign(R) Occupational Therapy. Am J Occup Ther. 2019 Sep/Oct;73(5):7305185020p1-7305185020p12. doi: 10.5014/ajot.2019.037317.
- Results publication: PubMed 34299957Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life balance intervention group program in people with Depression Disorders, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (baseline) (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975098, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.