NCT03851016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

February 20, 2019

Results QC Date

January 17, 2020

Last Update Submit

May 18, 2020

Conditions

Depressive SymptomsQuality of Life

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline and 3 weeks

  • 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.

    Baseline and 3 weeks

  • 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.

    Baseline and 3 weeks

Study Arms (2)

Life Story Book Intervention First, Then Usual Care

EXPERIMENTAL

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.

Behavioral: Life Story Book

Usual Care First, Then Life Story Book Intervention

EXPERIMENTAL

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.

Behavioral: Usual Care

Interventions

Life Story BookBEHAVIORAL

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.

Life Story Book Intervention First, Then Usual Care
Usual CareBEHAVIORAL

Three weeks of Usual Care with no visits from research team

Usual Care First, Then Life Story Book Intervention

Eligibility Criteria

Age57 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to speak English
  • A resident of the nursing home
  • A score of 4 or higher on the Six-Item Screener

You may not qualify if:

  • A score of 4 or higher on the Six-item Screener

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sharpview Residence and Rehabilitation Center

Houston, Texas, 77036, United States

Location

Cambridge Health Rehab Center

Richmond, Texas, 77469, United States

Location

Related Publications (7)

  • 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.

    PMID: 20925716BACKGROUND

  • 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.

    PMID: 16866815BACKGROUND

  • 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.

    PMID: 7183759BACKGROUND

  • 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.

    PMID: 10937538BACKGROUND

  • 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.

    BACKGROUND

  • Gibson, F. Reminiscence and life story work: A practice guide. Jessica Kingsley Publishers, 2011.

    BACKGROUND

  • Haight, Barbara K., and Barrett S. Haight. The handbook of structured life review. Baltimore, MD: Health Professions Press, 2007.

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Theresa C. Chrisman
Organization
University of Houston
tkchrisman@comcast.net
713-447-3334

Study Officials

  • Theresa C Chrisman, LMSW

    University of Houston

    PRINCIPAL INVESTIGATOR

  • Allen Rubin, PhD

    University of Houston

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Theresa C. Chrisman, PhD., LMSW

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

April 8, 2019

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

June 2, 2020

Results First Posted

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)