Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Hong Kong Polytechnic University | OTHER |
| The Hong Kong Society for the Blind | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Age-related Macular Degeneration (AMD) is an age-related eye disease resulting in vision loss. Persons with AMD not only experience a gradual loss of ability in independent living, but also profound impairment in psychosocial well-being.The multimodal, expressive arts-based intervention (EXABI) that emphasizes imagination and creativity can be an engaging, enjoyable, and safe process of empowerment. This study aims to investigate the effectiveness and process of an expressive arts-based intervention in enhancing psychosocial wellness and adjustment to gradual vision loss of persons with AMD. This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.
Age-related Macular Degeneration (AMD) is an age-related eye disease resulting in vision loss. Persons with AMD not only experience a gradual loss of ability in independent living, but also profound impairment in psychosocial well-being. Given the impacts of irreversible visual loss, persons with AMD need to actively adapt to changes and renegotiate supportive relations to maintain well-being. Psychosocial enhancement may buffer against the deteriorating quality of life, psychological distress, and poor adjustments among adults with AMD. The multimodal, expressive arts-based intervention (EXABI) that emphasizes imagination and creativity can be an engaging, enjoyable, and safe process of empowerment. The EXABI could help bypass or expand the limit of vision during interaction, and broaden the coping repertoire of those with AMD.
This study aims to investigate the effectiveness and process of an expressive arts-based intervention in enhancing psychosocial wellness and adjustment to gradual vision loss of persons with AMD. Primary outcomes include psychosocial adaptation, and vision-related quality of life; and secondary outcomes including symptoms of depression and anxiety, resilience, social support, and imagination as well as associations between psychosocial variables, participants' experience in the group, and factors affecting the effectiveness of the EXABI will be explored.
This proposed study adopts a randomized controlled trial with mixed methods design. To address the research objectives, data collected will be triangulated and interpreted simultaneously to address the research questions. Outcome measures will be assessed on four time-points (T0: Pre-intervention at baseline; T1: Post-intervention; T2: 3-month post-intervention and; T3: 6-month post-intervention) to assess the immediate and sustained effects of the expressive arts-based intervention on psychosocial wellbeing of the participants. Qualitative interviews will be conducted with a random subsample of 30 participants from the expressive arts group at T1 and T3 to collect fine-grained, information to explore their overall experience of participation in the intervention and how the experience has shaped their coping experience in terms of stress management, self-care challenges, and to reestablish severed social connections. Results of the qualitative interviews will be used to enhance the interpretation and understanding of the quantitative findings.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This arm of participants will be receiving expressive arts-based intervention as intervention |
|
| Wait-list control | No Intervention | This arm of participants will not receive any art-based intervention during the study and are allocated as a wait-list control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expressive Arts-Based Intervention | Behavioral | The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflection and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in intervention may seek meaning, clarity, insight and healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Baseline Psychosocial Adaptation Questionnaire for visual impairment level at 2 months, 5 months, and 8 months | Administration of the Chinese translated version of the 38-item Psychosocial Adaptation Questionnaire:
| Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8) |
| Change of Baseline Vision-related Quality of Life level at 2 months, 5 months, and 8 months | Administration of the Chinese translated version of the 13-item Vision-related Quality of Life Scale:
| Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Baseline Anxiety level at 2 months, 5 months, and 8 months | Administration of the Chinese translated version of the Hospital Anxiety and Depression Scale.
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rainbow Ho | Contact | (852)28315158 | tinho@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Rainbow Ho | Director/Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre on Behavioral Health, The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39806623 | Derived | Ho RTH, Cheong AMY, Wan AHY, Lo TLT, Fong TCT, Chan CKP, Li Q, Chan WC. Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degeneration. BMJ Open. 2024 Dec 20;14(12):e088311. doi: 10.1136/bmjopen-2024-088311. |
Not provided
Not provided
The data of this study are available from the principal investigator upon reasonable request. The data are not publicly available because they involve personal and clinical data from patients with age-related macular degeneration (AMD).
3 years after the completion of the study
The principal investigator will evaluate each request to determine if the data is accessible to other researchers.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Nov 21, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Parallel Randomized Controlled Trial
Not provided
Not provided
Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.
|
| Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8) |
| Change of Baseline Depression level at 2 months, 5 months, and 8 months | Administration of the Chinese translated version of the Hospital Anxiety and Depression Scale.
| Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8) |
| Change of Baseline Resilience level at 2 months, 5 months and 8 months | Administration of the Chinese translated version of the self-report Resilience Scale-14.
| Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8) |
| Change of Baseline Perceived Social Support level at 2 months, 5 months and 8 months | Administration of the Chinese version of the Multidimensional Scale of Perceived Social Support
| Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8) |
| Change of Baseline Imagination level at 2 months, 5 months, and 8 months | Administration of the Chinese translated version of the Self-Descriptive Imagination questionnaire.
| Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8) |
| Change of Baseline Imagination level at 2 months, 5 months, and 8 months | Administration of the Chinese translated version of the Fantastic Reality Ability Measurement.
| Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8) |