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

NCT ID: NCT06975098

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Depression Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Life balance intervention group

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.

Group Type EXPERIMENTAL

Life balance intervention group program

Intervention Type OTHER

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.

Interventions

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Life 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yun-Ling Chen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 12101852 (View on PubMed)

World 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/

Reference Type RESULT

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.

Reference Type RESULT
PMID: 21780985 (View on PubMed)

Wagman 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.

Reference Type RESULT
PMID: 31838931 (View on PubMed)

Wagman 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.

Reference Type RESULT
PMID: 24649971 (View on PubMed)

Uyeshiro 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.

Reference Type RESULT
PMID: 28661383 (View on PubMed)

Smith 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.

Reference Type RESULT
PMID: 3963137 (View on PubMed)

Skjutar 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.

Reference Type RESULT
PMID: 19653210 (View on PubMed)

Shang, 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).

Reference Type RESULT

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.

Reference Type RESULT
PMID: 17074942 (View on PubMed)

Pyatak 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.

Reference Type RESULT
PMID: 31484021 (View on PubMed)

Peral-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.

Reference Type RESULT
PMID: 34299957 (View on PubMed)

Mcmullen 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.

Reference Type RESULT
PMID: 28241904 (View on PubMed)

Mathers 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.

Reference Type RESULT
PMID: 17132052 (View on PubMed)

Magnusson 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.

Reference Type RESULT
PMID: 32186421 (View on PubMed)

Maeir T, Beit-Yosef A, Wechsler T, Safra Y, Zilbershlag Y, Katz N, Gilboa Y. The Feasibility and Efficacy of an Israeli Lifestyle Redesign(R)-Based Program for Well Older Adults: A Pilot Study. OTJR (Thorofare N J). 2021 Jan;41(1):47-55. doi: 10.1177/1539449220928141. Epub 2020 Jun 21.

Reference Type RESULT
PMID: 32567478 (View on PubMed)

Lund K, Hultqvist J, Bejerholm U, Argentzell E, Eklund M. Group leader and participant perceptions of Balancing Everyday Life, a group-based lifestyle intervention for mental health service users. Scand J Occup Ther. 2020 Aug;27(6):462-473. doi: 10.1080/11038128.2018.1551419. Epub 2019 Feb 1.

Reference Type RESULT
PMID: 30706746 (View on PubMed)

Lund K, Argentzell E, Bejerholm U, Eklund M. Breaking a cycle of perceived failure: The process of making changes toward a more balanced lifestyle. Aust Occup Ther J. 2019 Oct;66(5):627-636. doi: 10.1111/1440-1630.12604. Epub 2019 Jul 25.

Reference Type RESULT
PMID: 31344759 (View on PubMed)

Lund A, Michelet M, Sandvik L, Wyller T, Sveen U. A lifestyle intervention as supplement to a physical activity programme in rehabilitation after stroke: a randomized controlled trial. Clin Rehabil. 2012 Jun;26(6):502-12. doi: 10.1177/0269215511429473. Epub 2011 Dec 14.

Reference Type RESULT
PMID: 22169830 (View on PubMed)

Lin EC, Chan CH, Shao WC, Lin MF, Shiau S, Mueser KT, Huang SC, Wang HS. A randomized controlled trial of an adapted Illness Management and Recovery program for people with schizophrenia awaiting discharge from a psychiatric hospital. Psychiatr Rehabil J. 2013 Dec;36(4):243-9. doi: 10.1037/prj0000013.

Reference Type RESULT
PMID: 24320832 (View on PubMed)

Liao SC, Chen WJ, Lee MB, Lung FW, Lai TJ, Liu CY, Lin CY, Yang MJ, Chen CC. Low prevalence of major depressive disorder in Taiwanese adults: possible explanations and implications. Psychol Med. 2012 Jun;42(6):1227-37. doi: 10.1017/S0033291711002364. Epub 2011 Nov 4.

Reference Type RESULT
PMID: 22051196 (View on PubMed)

Lagueux E, Masse J, Levasseur M, Page R, Depelteau A, Levesque MH, Tousignant-Laflamme Y, Pinard AM. Pilot Study of French-Canadian Lifestyle Redesign(R) for Chronic Pain Management. OTJR (Thorofare N J). 2021 Apr;41(2):80-89. doi: 10.1177/1539449220982908. Epub 2021 Jan 3.

Reference Type RESULT
PMID: 33393417 (View on PubMed)

Krupa, T., Kirsh, B., Pitts, D., & Fossey, E. (2016). Bruce & Borg's Psychosocial Frames of Reference: Theories, Models and Approaches for Occupation-Based Practice (4th ed.). Slack.

Reference Type RESULT

Johansson C, Isaksson G. Experiences of participation in occupations of women on long-term sick leave. Scand J Occup Ther. 2011 Dec;18(4):294-301. doi: 10.3109/11038128.2010.521950. Epub 2010 Oct 21.

Reference Type RESULT
PMID: 20961264 (View on PubMed)

Jakobsen K, Magnus E, Lundgren S, Reidunsdatter RJ. Everyday life in breast cancer survivors experiencing challenges: A qualitative study. Scand J Occup Ther. 2018 Jul;25(4):298-307. doi: 10.1080/11038128.2017.1335777. Epub 2017 May 31.

Reference Type RESULT
PMID: 28562163 (View on PubMed)

Hultqvist J, Lund K, Argentzell E, Eklund M. Predictors of clinically important improvements in occupational and quality of life outcomes among mental health service users after completion and follow-up of a lifestyle intervention: multiple regression modelling based on longitudinal data. BMC Psychol. 2019 Dec 17;7(1):83. doi: 10.1186/s40359-019-0359-z.

Reference Type RESULT
PMID: 31847910 (View on PubMed)

Huang CY, Sousa VD, Tsai CC, Hwang MY. Social support and adaptation of Taiwanese adults with mental illness. J Clin Nurs. 2008 Jul;17(13):1795-802. doi: 10.1111/j.1365-2702.2008.02310.x.

Reference Type RESULT
PMID: 18578782 (View on PubMed)

Hakansson C, Wagman P, Hagell P. Construct validity of a revised version of the Occupational Balance Questionnaire. Scand J Occup Ther. 2020 Aug;27(6):441-449. doi: 10.1080/11038128.2019.1660801. Epub 2019 Sep 14.

Reference Type RESULT
PMID: 31524026 (View on PubMed)

Gunnarsson, B. (2008). The Tree Theme Method-An Occupational Therapy Intervention Applied in Outpatient Psychiatric Care (Vol. 2008). Lund University.

Reference Type RESULT

Gunnarsson AB, Wagman P, Hakansson C, Hedin K. The Tree Theme Method(R) (TTM), an occupational therapy intervention for treating depression and anxiety: study protocol of a randomized controlled trial. BMC Psychol. 2015 Nov 9;3:40. doi: 10.1186/s40359-015-0097-9.

Reference Type RESULT
PMID: 26552426 (View on PubMed)

Gunnarsson AB, Jansson JA, Eklund M. The Tree Theme Method in psychosocial occupational therapy: a case study. Scand J Occup Ther. 2006 Dec;13(4):229-40. doi: 10.1080/11038120600772908.

Reference Type RESULT
PMID: 17203673 (View on PubMed)

Gunnarsson AB, Hakansson C, Hedin K, Wagman P. Outcomes of the Tree Theme Method versus regular occupational therapy: A longitudinal follow-up. Aust Occup Ther J. 2022 Aug;69(4):379-390. doi: 10.1111/1440-1630.12796. Epub 2022 Mar 7.

Reference Type RESULT
PMID: 35257386 (View on PubMed)

Gunnarsson AB, Eklund M. The Tree Theme Method as an intervention in psychosocial occupational therapy: client acceptability and outcomes. Aust Occup Ther J. 2009 Jun;56(3):167-76. doi: 10.1111/j.1440-1630.2008.00738.x.

Reference Type RESULT
PMID: 20854510 (View on PubMed)

GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.

Reference Type RESULT
PMID: 35026139 (View on PubMed)

Eklund M, Tjornstrand C, Sandlund M, Argentzell E. Effectiveness of Balancing Everyday Life (BEL) versus standard occupational therapy for activity engagement and functioning among people with mental illness - a cluster RCT study. BMC Psychiatry. 2017 Nov 9;17(1):363. doi: 10.1186/s12888-017-1524-7.

Reference Type RESULT
PMID: 29121882 (View on PubMed)

Eklund M, Orban K, Argentzell E, Bejerholm U, Tjornstrand C, Erlandsson LK, Hakansson C. The linkage between patterns of daily occupations and occupational balance: Applications within occupational science and occupational therapy practice. Scand J Occup Ther. 2017 Jan;24(1):41-56. doi: 10.1080/11038128.2016.1224271. Epub 2016 Aug 30.

Reference Type RESULT
PMID: 27575654 (View on PubMed)

Eklund M, Lund K, Argentzell E. The impact of the BEL intervention on levels of motivation, engagement and recovery in people who attend community mental health services. Scand J Occup Ther. 2023 Aug;30(6):862-872. doi: 10.1080/11038128.2023.2184717. Epub 2023 Mar 3.

Reference Type RESULT
PMID: 36867590 (View on PubMed)

Eklund M, Leufstadius C, Bejerholm U. Time use among people with psychiatric disabilities: implications for practice. Psychiatr Rehabil J. 2009 Winter;32(3):177-91. doi: 10.2975/32.3.2009.177.191.

Reference Type RESULT
PMID: 19136350 (View on PubMed)

Eklund M, Brunt D, Argentzell E. Perceived occupational balance and well-being among people with mental illness living in two types of supported housing. Scand J Occup Ther. 2020 Aug;27(6):450-461. doi: 10.1080/11038128.2019.1622771. Epub 2019 Jun 7.

Reference Type RESULT
PMID: 31170857 (View on PubMed)

Eklund M, Argentzell E. Perception of occupational balance by people with mental illness: A new methodology. Scand J Occup Ther. 2016 Jul;23(4):304-13. doi: 10.3109/11038128.2016.1143529. Epub 2016 Feb 12.

Reference Type RESULT
PMID: 26872496 (View on PubMed)

Crist, P. H., Davis, C. G., & Coffin, P. S. (2000). The effects of employment and mental health status on the balance of work, play/leisure, self-care, and rest. Occupational Therapy in Mental Health, 15(1), 27-42. https://doi.org/10.1300/J004v15n01_02

Reference Type RESULT

Chen YL, Pan AW, Hsiung PC, Chung L, Lai JS, Shur-Fen Gau S, Chen TJ. Life Adaptation Skills Training (LAST) for persons with depression: A randomized controlled study. J Affect Disord. 2015 Oct 1;185:108-14. doi: 10.1016/j.jad.2015.06.022. Epub 2015 Jun 27.

Reference Type RESULT
PMID: 26162281 (View on PubMed)

Chen, H. (2000). Manual for the Beck Depression Inventory-II (Chinese version). Chinese Behavioural Science Corporation.

Reference Type RESULT

Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.

Reference Type RESULT
PMID: 15586853 (View on PubMed)

Brown, C., Stoffel, V. C., & Muňoz, J. P. (2019). Occupational Therapy in Mental Health: A Vision for Participation (2nd ed.). F.A. Davis. .

Reference Type RESULT

Birgitta Gunnarsson A, Wagman P, Hedin K, Hakansson C. Treatment of depression and/or anxiety - outcomes of a randomised controlled trial of the tree theme method(R) versus regular occupational therapy. BMC Psychol. 2018 May 23;6(1):25. doi: 10.1186/s40359-018-0237-0.

Reference Type RESULT
PMID: 29792226 (View on PubMed)

Bakish D. New standard of depression treatment: remission and full recovery. J Clin Psychiatry. 2001;62 Suppl 26:5-9.

Reference Type RESULT
PMID: 11775091 (View on PubMed)

Occupational Therapy Practice Framework: Domain and Process-Fourth Edition. Am J Occup Ther. 2020 Aug 1;74(Supplement_2):7412410010p1-7412410010p87. doi: 10.5014/ajot.2020.74S2001.

Reference Type RESULT
PMID: 34780625 (View on PubMed)

Other Identifiers

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CS2-23222

Identifier Type: -

Identifier Source: org_study_id

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