DepressionNCT00321971
Prevention of Depression in Spouses of People With Cognitive Impairment
A study testing PST-MCI/AD Caregiving and NT-MCI/AD Caregiving in people with Depression, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- PST-MCI/AD Caregiving and NT-MCI/AD Caregiving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Dec 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not speak English
- Cohabitating adult child of a person with MCI
- Resides in an institutional or assisted-living setting
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Alzheimer's Disease Research Center (ADRC)
Pittsburgh, Pennsylvania, 15213
Duquesne Univeristy
Pittsburgh, Pennsylvania, 15282
About this study
Official title: Prevention of Psychiatric Morbidity in AD Caregivers
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.
Read the 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.
- Conditions
- Depression
- Being tested
- PST-MCI/AD Caregiving, NT-MCI/AD Caregiving
- Keywords
- Anxiety, Mild Cognitive Impairment, MCI, Cognitive Impairment, Alzheimer's Disease, Caregiver Burden, Caregiver Stress, Family Dementia Caregiving, Spousal Dementia Caregiving
- Medical subject headings
- Depression, Anxiety Disorders, Cognitive Dysfunction, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PST-MCI/AD CaregivingBehavioural
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.
NT-MCI/AD CaregivingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PST-MCI/AD Caregiving | Experimental | The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It was adapted from a manualized protocol for PST use in primary care. Our adaptation sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressor. Receives: Behavioral: PST-MCI/AD Caregiving |
| NT-MCI/AD Caregiving | Active comparator | The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) 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. Receives: Behavioral: NT-MCI/AD Caregiving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1-, 3-, 6-, and 12- months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startFeb 2007
- Primary completionDec 2011
- Study completionDec 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Linda Garand, Duquesne University
- Investigators
- Linda J. Garand, PhD, Principal investigator, The University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321971
- Sponsor's protocol ID
- K23MH070719
- Other IDs
- K23MH070719
- Status last verified
- Mar 2018
- First submitted
- 2 May 2006
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garand L, Dew MA, Eazor LR, DeKosky ST, Reynolds CF 3rd. Caregiving burden and psychiatric morbidity in spouses of persons with mild cognitive impairment. Int J Geriatr Psychiatry. 2005 Jun;20(6):512-22. doi: 10.1002/gps.1318.
PubMed 15920711Garand L, Rinaldo DE, Alberth MM, Delany J, Beasock SL, Lopez OL, Reynolds CF 3rd, Dew MA. Effects of problem solving therapy on mental health outcomes in family caregivers of persons with a new diagnosis of mild cognitive impairment or early dementia: a randomized controlled trial. Am J Geriatr Psychiatry. 2014 Aug;22(8):771-81. doi: 10.1016/j.jagp.2013.07.007. Epub 2013 Oct 8.
PubMed 24119856Garand L, Morse JQ, ChiaRebecca L, Barnes J, Dadebo V, Lopez OL, Dew MA. Problem-solving therapy reduces subjective burden levels in caregivers of family members with mild cognitive impairment or early-stage dementia: Secondary analysis of a randomized clinical trial. Int J Geriatr Psychiatry. 2019 Jul;34(7):957-965. doi: 10.1002/gps.5095. Epub 2019 Apr 17.
PubMed 30868641
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Psychiatric Morbidity in AD Caregivers
- ClinicalTrials.gov ID
- NCT00321971
- Acronym / sponsor ID
- K23MH070719
- Conditions
- Depression
- Keywords
- Anxiety, Mild Cognitive Impairment, MCI, Cognitive Impairment, Alzheimer's Disease, Caregiver Burden, Caregiver Stress, Family Dementia Caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Posted 7 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PST-MCI/AD Caregiving | Experimental | Behavioral: PST-MCI/AD CaregivingThe experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It was adapted from a manualized protocol for PST use in primary care. Our adaptation sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressor. |
| NT-MCI/AD Caregiving | Active comparator | Behavioral: NT-MCI/AD CaregivingThe comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Does not speak English
- Cohabitating adult child of a person with MCI
- Resides in an institutional or assisted-living setting
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 |
|---|---|---|
| PST-MCI/AD CaregivingThe 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. | Behavioural | PST-MCI/AD Caregiving |
| NT-MCI/AD CaregivingThe 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. | Behavioural | NT-MCI/AD Caregiving |
Primary outcome
Depressive Symptoms
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15920711Garand L, Dew MA, Eazor LR, DeKosky ST, Reynolds CF 3rd. Caregiving burden and psychiatric morbidity in spouses of persons with mild cognitive impairment. Int J Geriatr Psychiatry. 2005 Jun;20(6):512-22. doi: 10.1002/gps.1318.
- Results publication: PubMed 24119856Garand L, Rinaldo DE, Alberth MM, Delany J, Beasock SL, Lopez OL, Reynolds CF 3rd, Dew MA. Effects of problem solving therapy on mental health outcomes in family caregivers of persons with a new diagnosis of mild cognitive impairment or early dementia: a randomized controlled trial. Am J Geriatr Psychiatry. 2014 Aug;22(8):771-81. doi: 10.1016/j.jagp.2013.07.007. Epub 2013 Oct 8.
- Derived from this study: PubMed 30868641Garand L, Morse JQ, ChiaRebecca L, Barnes J, Dadebo V, Lopez OL, Dew MA. Problem-solving therapy reduces subjective burden levels in caregivers of family members with mild cognitive impairment or early-stage dementia: Secondary analysis of a randomized clinical trial. Int J Geriatr Psychiatry. 2019 Jul;34(7):957-965. doi: 10.1002/gps.5095. Epub 2019 Apr 17.
- 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.
Linda J. Garand, PhD principal investigator
The University of Pittsburgh School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PST-MCI/AD Caregiving and NT-MCI/AD Caregiving in people with Depression, run by University of Pittsburgh 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 1 inclusion and 3 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 3 Apr 2018. 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 7 Mar 2018). 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?
Depressive Symptoms (time frame: Baseline and 1-, 3-, 6-, and 12- months post-treatment). 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 NCT00321971, which also lists 3 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 3 Apr 2018.