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Life Story Book With Mentally Alert Residents of Nursing Homes

Primary Purpose

Depressive Symptoms, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Story Book
Usual Care
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

57 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sharpview Residence and Rehabilitation Center
  • Cambridge Health Rehab Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Life Story Book Intervention First, Then Usual Care

Usual Care First, Then Life Story Book Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Scores for Geriatric Depression Scale at 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.
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Presence of Meaning (POM) at 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.
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Search for Meaning (SFM) at 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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2019
Last Updated
May 18, 2020
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03851016
Brief Title
Life Story Book With Mentally Alert Residents of Nursing Homes
Official Title
The Effectiveness of Life Story Book on Depression and Meaning in Life for Mentally Alert Residents of Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to study the effects of the Life Story Book intervention on depressive symptoms and meaning in life for mentally alert residents of nursing homes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A switching replication design was employed to examine the effects of the Life Story Book (LSB). Two comparable nursing homes were allocated to each intervention. Participants in each nursing home received the same intervention at the same time.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Life Story Book Intervention First, Then Usual Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care First, Then Life Story Book Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Life Story Book
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Three weeks of Usual Care with no visits from research team
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Presence of Meaning (POM) at 3 Weeks.
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Search for Meaning (SFM) at 3 Weeks
Description
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.
Time Frame
Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa C Chrisman, LMSW
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allen Rubin, PhD
Organizational Affiliation
University of Houston
Official's Role
Study Chair
Facility Information:
Facility Name
Sharpview Residence and Rehabilitation Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Cambridge Health Rehab Center
City
Richmond
State/Province
Texas
ZIP/Postal Code
77469
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20925716
Citation
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.
Results Reference
background
PubMed Identifier
16866815
Citation
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.
Results Reference
background
PubMed Identifier
7183759
Citation
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.
Results Reference
background
PubMed Identifier
10937538
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Gibson, F. Reminiscence and life story work: A practice guide. Jessica Kingsley Publishers, 2011.
Results Reference
background
Citation
Haight, Barbara K., and Barrett S. Haight. The handbook of structured life review. Baltimore, MD: Health Professions Press, 2007.
Results Reference
background

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Life Story Book With Mentally Alert Residents of Nursing Homes

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