Depression
Conditions
Keywords
Anxiety, Mild Cognitive Impairment, MCI, Cognitive Impairment, Alzheimer's Disease, Caregiver Burden, Caregiver Stress, Family Dementia Caregiving, Spousal Dementia Caregiving
Brief summary
This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or family caregivers of persons with mild cognitive impairment or early dementia.
Detailed description
People with a diagnosis of mild cognitive impairment (MCI) have an estimated 12% probability each year of progressing to a dementing disorder. Pilot data suggest that the spouses of people with MCI begin to adopt the caregiver role and its burdens as they cope with this condition. Although levels of caregiver burden and psychiatric illness are lower than those typically observed in family dementia caregiving samples, our findings suggest that MCI spousal caregivers have already begun to experience distress associated with elevated caregiver burden. In order to protect the mental health and well-being of caregivers as they cope with their spouses' current and future health care needs, it may be ideal to implement selective preventive strategies while they are in the very earliest stages of caregiving. This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or significant others of people with MCI. Participants in this open-label study are randomly assigned to receive either a self-management intervention targeted at problem-solving training or an attention-matched intervention targeted at nutritional education. The self-management intervention trains participants to effectively use problem-solving skills with the aim of strengthening their ability to cope with burdens of caregiving and preventing the onset or worsening of depression. The nutritional education program is based on the new United States Department of Health and Human Services 2005 dietary recommendations. All participants attend weekly individual training sessions, either in their home or another convenient location for a total of 6 weeks. At the end of 6 weeks, participants receive a weekly phone call for an additional 3 weeks to support the training they received. Follow-up data is collected at Months 1, 3, 6, and 12 post-intervention. If a participant's spouse is diagnosed with dementia during the study, additional follow-up data is collected after the Month 12 visit.
Interventions
BEHAVIORALPST-MCI/AD Caregiving
The PST-based intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.
BEHAVIORALNT-MCI/AD Caregiving
The nutritional education program will be based on the new USSDA dietary recommendations. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Spouse or non-married partner of a patient being treated at the University of Pittsburgh Alzheimer's Disease Research Center (ADRC) for a new or subsequent diagnosis of MCI
Exclusion criteria
* Does not speak English * Cohabitating adult child of a person with MCI * Resides in an institutional or assisted-living setting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Baseline and 1-, 3-, 6-, and 12- months post-treatment | Depressive symptoms were measured with Center for Epidemiological Studies - Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach's alpha = .88) and predictive validity for the diagnosis of depression. |
Countries
United States
Participant flow
Recruitment details
The University of Pittsburgh ADRC patient registry was searched for all cases diagnosed with MCI in the 6 months before the start of data collection and new cases of MCI or early dementia (any type) diagnosed at the ADRC during the subsequent 46-month time frame. Participants had to live with the person with MCI or early dementia
Participants by arm
| Arm | Count |
|---|---|
| Problem Solving Training (PST) The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention. | 36 |
| Nutritional Training (NT) The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions. Participants were asked to keep a record of menu planning, eating habits between session, and any questions they had related to the application of NT. These records were used as a basis for discussion during both phases of the intervention | 37 |
| Total | 73 |
Baseline characteristics
| Characteristic | Problem Solving Training (PST) | Total | Nutritional Training (NT) |
|---|---|---|---|
| Age, Continuous | 66.4 Years STANDARD_DEVIATION 8 | 64.98 Years STANDARD_DEVIATION 11.3 | 63.4 Years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 73 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 72 Participants | 37 Participants |
| Region of Enrollment United States | 36 Participants | 73 Participants | 37 Participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 37 |
Outcome results
Primary
Depressive Symptoms
Depressive symptoms were measured with Center for Epidemiological Studies - Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach's alpha = .88) and predictive validity for the diagnosis of depression.
Time frame: Baseline and 1-, 3-, 6-, and 12- months post-treatment
Population: Using an intention-to-treat approach, we performed a repeated-measures linear mixed effects analysis for each study outcome. This analysis included group assignment (PST-MCI/AD Caregiving vs NT), type of caregiver (MCI versus dementia), and time (baseline, 1-, 3-, 6-, and 12-month follow-up). The depression data were log-transformed for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Problem Solving Intervention | Depressive Symptoms | 1 Month Follow-up | 8.880 units on a scale | Standard Deviation 1.777 |
| Problem Solving Intervention | Depressive Symptoms | 6 Month Follow-up | 6.885 units on a scale | Standard Deviation 1.689 |
| Problem Solving Intervention | Depressive Symptoms | 3 Month Follow-up | 8.766 units on a scale | Standard Deviation 1.927 |
| Problem Solving Intervention | Depressive Symptoms | 12 Month Follow-Up | 6.475 units on a scale | Standard Deviation 1.619 |
| Problem Solving Intervention | Depressive Symptoms | Baseline | 9.736 units on a scale | Standard Deviation 1.594 |
| Nutritional Intervention | Depressive Symptoms | 12 Month Follow-Up | 14.143 units on a scale | Standard Deviation 1.571 |
| Nutritional Intervention | Depressive Symptoms | Baseline | 11.785 units on a scale | Standard Deviation 1.515 |
| Nutritional Intervention | Depressive Symptoms | 1 Month Follow-up | 12.300 units on a scale | Standard Deviation 1.715 |
| Nutritional Intervention | Depressive Symptoms | 3 Month Follow-up | 13.157 units on a scale | Standard Deviation 1.848 |
| Nutritional Intervention | Depressive Symptoms | 6 Month Follow-up | 13.831 units on a scale | Standard Deviation 1.637 |
Comparison: Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.p-value: <0.0595% CI: [0.208, 0.657]Mixed Models Analysis