Depressive SymptomsNCT03851016
Life Story Book With Mentally Alert Residents of Nursing Homes
A study testing Life Story Book in people with Depressive Symptoms and Quality of Life, run by University of Houston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 57 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Quality of Life
- What is being tested?
- Life Story Book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2019to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 57 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to speak English
- A resident of the nursing home
- A score of 4 or higher on the Six-Item Screener
Who cannot join
- A score of 4 or higher on the Six-item Screener
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sharpview Residence and Rehabilitation Center
Houston, Texas, 77036
Cambridge Health Rehab Center
Richmond, Texas, 77469
About this study
Official title: The Effectiveness of Life Story Book on Depression and Meaning in Life for Mentally Alert Residents of Nursing Homes
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.
Read the 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.
- Conditions
- Depressive Symptoms, Quality of Life
- Being tested
- Life Story Book, Usual Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Story BookBehavioural
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.
Usual CareBehavioural
Three weeks of Usual Care with no visits from research team
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start8 Apr 2019
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa C. Chrisman, University of Houston
- Investigators
- Theresa C Chrisman, LMSW, Principal investigator, University of HoustonAllen Rubin, PhD, Study chair, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851016
- Sponsor's protocol ID
- Study00001439
- Status last verified
- May 2020
- First submitted
- 20 Feb 2019
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20925716McKeown 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.
PubMed 16866815Yesavage 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.
PubMed 7183759Sutcliffe 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.
PubMed 10937538Steger, 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 at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Life Story Book on Depression and Meaning in Life for Mentally Alert Residents of Nursing Homes
- ClinicalTrials.gov ID
- NCT03851016
- Acronym / sponsor ID
- Study00001439
- Conditions
- Depressive Symptoms, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Life Story Book Intervention First, Then Usual Care | Experimental | Behavioral: Life Story BookParticipants 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. |
| Usual Care First, Then Life Story Book Intervention | Experimental | Behavioral: Usual CareParticipants 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. |
Who may qualify
- Ages
- 57 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to speak English
- A resident of the nursing home
- A score of 4 or higher on the Six-Item Screener
Key exclusion criteria (1 listed)
- A score of 4 or higher on the Six-item Screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Story BookLife story Book is intended to allow a person the opportunity to reminisce chronologically through their life and capture their life stories into a book. | Behavioural | Life Story Book Intervention First, Then Usual Care |
| Usual CareThree weeks of Usual Care with no visits from research team | Behavioural | Usual Care First, Then Life Story Book Intervention |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20925716McKeown 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.
- Background: PubMed 16866815McKeown 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.
- Background: PubMed 7183759Yesavage 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.
- Background: PubMed 10937538Sutcliffe 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.
- BackgroundSteger, 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.
- BackgroundGibson, F. Reminiscence and life story work: A practice guide. Jessica Kingsley Publishers, 2011.
- BackgroundHaight, Barbara K., and Barrett S. Haight. The handbook of structured life review. Baltimore, MD: Health Professions Press, 2007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa C Chrisman, LMSW principal investigator
University of Houston
Allen Rubin, PhD study chair
University of Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Story Book in people with Depressive Symptoms and Quality of Life, run by University of Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks (time frame: Baseline and 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03851016, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.