Depressive Symptoms, Quality of Life
Conditions
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.
Interventions
BEHAVIORALLife Story Book
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.
BEHAVIORALUsual Care
Three weeks of Usual Care with no visits from research team
Sponsors
University of Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
57 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks | 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. | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
27 residents were screened for eligibility between April 08, 2019 and April 12, 2019 from two comparable nursing homes in the Houston Texas Metropolitan area.
Pre-assignment details
24 of the 27 participants, 12 from each home met inclusion criteria. The two nursing homes were allocated by the PI to either Life Story Book Intervention first or Usual Care first. All participants in the same nursing home received the same intervention at the same time.
Participants by arm
| Arm | Count |
|---|---|
| Life Story Book Intervention First, Then Usual Care Participants first received the Life Story Book Intervention for one hour a week for three weeks. After a washout period of 1 week, they then received three weeks of usual care. | 11 |
| Usual Care First, Then Life Story Book Intervention Participants received three weeks of usual care first. After a washout period of 1 week, they then received three weeks of the Life Story Book Intervention | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (3 Weeks) | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Life Story Book Intervention First, Then Usual Care | Usual Care First, Then Life Story Book Intervention | Total |
|---|---|---|---|
| Age, Continuous | 77.1 years STANDARD_DEVIATION 11 | 72.1 years STANDARD_DEVIATION 11.7 | 74.6 years STANDARD_DEVIATION 11.4 |
| Education, Categorical College Graduate, plus | 3 Participants | 0 Participants | 3 Participants |
| Education, Categorical Grades 9-11 | 2 Participants | 1 Participants | 3 Participants |
| Education, Categorical High School or GED | 4 Participants | 2 Participants | 6 Participants |
| Education, Categorical Some College/Tech | 2 Participants | 7 Participants | 9 Participants |
| Katz Index of Independence in Activities of Daily Living (ADL) Continuous | 1.27 units on a scale STANDARD_DEVIATION 0.65 | 3.0 units on a scale STANDARD_DEVIATION 2.3 | 2.135 units on a scale STANDARD_DEVIATION 1.8 |
| Length of Time at Residence Less than 1 Year | 5 Participants | 1 Participants | 6 Participants |
| Length of Time at Residence One-two years | 6 Participants | 6 Participants | 12 Participants |
| Length of Time at Residence Three or more years | 0 Participants | 3 Participants | 3 Participants |
| Marital Status, Categorical Divorced | 3 Participants | 3 Participants | 6 Participants |
| Marital Status, Categorical Married | 0 Participants | 1 Participants | 1 Participants |
| Marital Status, Categorical Single | 1 Participants | 2 Participants | 3 Participants |
| Marital Status, Categorical Widow (R) | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Ethnicity African American | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White | 6 Participants | 5 Participants | 11 Participants |
| Religion Catholic/Other | 3 Participants | 2 Participants | 5 Participants |
| Religion Protestant | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
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.
Time frame: Baseline and 3 weeks
Population: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Story Book Intervention | Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks | 1.00 score on a scale | Standard Deviation 2.07 |
| Usual Care | Change From Baseline in Mean Scores for Geriatric Depression Scale at 3 Weeks | -.29 score on a scale | Standard Deviation 1.68 |
Comparison: Null hypothesis is that there would be no difference in change of depressive symptoms between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the GDS-12R at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in depressive symptoms.p-value: 0.113Mancova
Primary
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.
Time frame: Baseline and 3 weeks
Population: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Story Book Intervention | Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Presence of Meaning (POM) at 3 Weeks. | .952 score on a scale | Standard Deviation 6.18 |
| Usual Care | Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Presence of Meaning (POM) at 3 Weeks. | -13.10 score on a scale | Standard Deviation 13.78 |
Comparison: Null hypothesis is that there would be no difference in change of Presence of Meaning (POM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the POM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in POM.p-value: 0.123Mancova
Primary
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.
Time frame: Baseline and 3 weeks
Population: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Life Story Book Intervention | Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Search for Meaning (SFM) at 3 Weeks | -2.62 score on a scale | Standard Deviation 10.11 |
| Usual Care | Change From Baseline in Mean Scores for Meaning in Life Questionnaire Sub-Scale Search for Meaning (SFM) at 3 Weeks | 12.24 score on a scale | Standard Deviation 13.11 |
Comparison: The null hypothesis is that there would be no difference in change of Search for Meaning (SFM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the SFM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in SFM.p-value: 0.91Mancova