- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851016
Life Story Book With Mentally Alert Residents of Nursing Homes
The Effectiveness of Life Story Book on Depression and Meaning in Life for Mentally Alert Residents of Nursing Homes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two nursing homes were recruited to participate. One nursing home will receive the Life Story Book intervention while the other half receives Usual Care intervention. The interventions were then switched, and the participants who received Usual Care intervention received the Life Story Book intervention while the home that received Life Story Book intervention received Usual Care intervention. The study consisted of two treatment periods of 3 weeks separated by a washout period of 1 week.
Life Story Book provides a person with the opportunity to chronologically share their life experiences and memories. This three-1 hour reminiscence intervention is designed to provide a person with the opportunity to review their past and capture their life story into something tangible. The Life Story Book includes a combination of written information, photographs of significant people, places or events, and personal narratives from the stages of life that the person would like to include.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Texas
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Houston, Texas, United States, 77036
- Sharpview Residence and Rehabilitation Center
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Richmond, Texas, United States, 77469
- Cambridge Health Rehab Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ability to speak English
- A resident of the nursing home
- A score of 4 or higher on the Six-Item Screener
Exclusion Criteria:
- A score of 4 or higher on the Six-item Screener
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Life Story Book Intervention First, Then Usual Care
Participants first received the Life Story Book Intervention once a week for 3 weeks.
After a washout period of 1 week, they then received the Usual Care Intervention for 3 weeks.
Posttests were then conducted for 1 week.
|
Life story Book is intended to allow a person the opportunity to reminisce chronologically through their life and capture their life stories into a book.
|
Experimental: Usual Care First, Then Life Story Book Intervention
Participants first received the Usual Care Intervention for 3 weeks.
After a washout period of 1 week, they then received the Life Story Book Intervention once a week for 3 weeks.
Posttests were then conducted for 1 week.
|
Three weeks of Usual Care with no visits from research team
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks
Time Frame: Baseline and 3 weeks
|
The Geriatric Depression Scale (Residential) (GDS-12R) is a validated, self-reported instrument assessing depression over the past 7 days.
It is a "yes/no" format.
Possible scores range from 0 (no depressive symptoms) to 10 (depression).
A score of 0 to 4 is normal; scores ≥ 4 are significant for depressive symptoms; scores ≥ 08 is almost always indicative of depression.
A score ≥ 5 points should warrant a follow-up comprehensive assessment.
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Baseline and 3 weeks
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Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Presence of Meaning (POM) at 3 Weeks.
Time Frame: Baseline and 3 weeks
|
Meaning in Life was measured using the Meaning in Life Questionnaire (MLQ), created by Steger et al. The MLQ has two sub-scales which assess the presence of meaning (POM) (how much a person feels their life has meaning) and the search for meaning (how much a person strives to find meaning and understanding in their life). The two sub-scale measures, which consist of 10 items on a 7-point Likert scale, range from 1-absolutely true to 7-absolutely untrue: five items for presence of meaning (POM) and five items for search for meaning (SFM). A POM score > 24 indicates the person feels their life has meaning and purpose. |
Baseline and 3 weeks
|
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Search for Meaning (SFM) at 3 Weeks
Time Frame: Baseline and 3 weeks
|
Meaning in Life was measured using the Meaning in Life Questionnaire (MLQ), created by Steger et al.The MLQ has two sub-scales which assess the presence of meaning (how much a person feels their life has meaning) and the search for meaning (how much a person strives to find meaning and understanding in their life). The two sub-scale measures, which consist of 10 items on a 7-point Likert scale, range from 1-absolutely true to 7-absolutely untrue: five items for presence of meaning (POM) and five items for search for meaning (SFM). An SFM score of < 24 indicates the person is not seeking meaning in their life. |
Baseline and 3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Theresa C Chrisman, LMSW, University of Houston
- Study Chair: Allen Rubin, PhD, University of Houston
Publications and helpful links
General Publications
- Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
- McKeown J, Clarke A, Ingleton C, Ryan T, Repper J. The use of life story work with people with dementia to enhance person-centred care. Int J Older People Nurs. 2010 Jun;5(2):148-58. doi: 10.1111/j.1748-3743.2010.00219.x.
- McKeown J, Clarke A, Repper J. Life story work in health and social care: systematic literature review. J Adv Nurs. 2006 Jul;55(2):237-47. doi: 10.1111/j.1365-2648.2006.03897.x.
- Sutcliffe C, Cordingley L, Burns A, Mozley CG, Bagley H, Huxley P, Challis D. A new version of the geriatric depression scale for nursing and residential home populations: the geriatric depression scale (residential) (GDS-12R). Int Psychogeriatr. 2000 Jun;12(2):173-81. doi: 10.1017/s104161020000630x.
- Steger, M. F., Frazier, P., Oishi, S., & Kaler, M. The meaning in life questionnaire: Assessing the presence of and search for meaning in life. Journal of counseling psychology 53(1): 80-93, 2006.
- Gibson, F. Reminiscence and life story work: A practice guide. Jessica Kingsley Publishers, 2011.
- Haight, Barbara K., and Barrett S. Haight. The handbook of structured life review. Baltimore, MD: Health Professions Press, 2007.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study00001439
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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