Dementia Clinical Trial in White Plains NY
NCT01350349
| Interventional
This study has recruited 134 Participants
Among older adults the combination of depression, cognitive impairment (memory problems), and
disability contribute to a worsening of physical and mental health and to poor treatment
outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems
achieve remission from their depression. Interventions involving talking therapy are
underdeveloped and understudied. Therefore, this research study will test the efficacy of
Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders
with major depression, memory problems, and disability. PATH focuses on the subject's
"ecosystem" (the patient, the caregiver, and the home-environment) and targets behavioral
problems related to both depression and disability.
PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most
of their difficulties. Local Home Delivered Meals programs will refer clients who have
symptoms of depression and are interested in research. All participants will have an
available caregiver (family, significant other, or professional) and will be randomized to 12
weekly sessions of PATH or Supportive Therapy, the current standard of care for talking
therapy. The study will test whether home-delivered PATH is more effective than
home-delivered Supportive Therapy in reducing the subjects' depression and disability and in
increasing self-efficacy over the 12-week treatment period.
Details for the study
Brief Title
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Official Title
Home-delivered Intervention for Depressed, Cognitively Impaired Elders
Brief Summary
Among older adults the combination of depression, cognitive impairment (memory problems), and<br /> disability contribute to a worsening of physical and mental health and to poor treatment<br /> outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems<br /> achieve remission from their depression. Interventions involving talking therapy are<br /> underdeveloped and understudied. Therefore, this research study will test the efficacy of<br /> Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders<br /> with major depression, memory problems, and disability. PATH focuses on the subject's<br /> "ecosystem" (the patient, the caregiver, and the home-environment) and targets behavioral<br /> problems related to both depression and disability.<br /><br /> PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most<br /> of their difficulties. Local Home Delivered Meals programs will refer clients who have<br /> symptoms of depression and are interested in research. All participants will have an<br /> available caregiver (family, significant other, or professional) and will be randomized to 12<br /> weekly sessions of PATH or Supportive Therapy, the current standard of care for talking<br /> therapy. The study will test whether home-delivered PATH is more effective than<br /> home-delivered Supportive Therapy in reducing the subjects' depression and disability and in<br /> increasing self-efficacy over the 12-week treatment period.
Detailed Description
Depression, cognitive impairment and disability often coexist in older adults and contribute
to medical and psychiatric morbidity and mortality. We developed and propose to test the
efficacy of a new psychosocial intervention, Problem Adaptation Therapy (PATH), for patients
with major depression, cognitive impairment (up to the level of mild to moderate dementia)
and disability. The proposed R01 study meets a critical need of this population, i.e. a
treatment alternative for patients in whom antidepressants may have limited efficacy and for
whom psychosocial interventions are underdeveloped and understudied.
The principal innovation of PATH is its personalized approach focusing on the patient's
ecosystem (i.e. the patient, the caregiver, and the home-environment) and targeting
behavioral problems related to both depression and disability. PATH is delivered at the
patients' home, teaches the patient-caregiver dyad problem-solving skills, and incorporates
environmental adaptations (including notes, signs, reminders, calendars, voice alarms) to
improve the patient's functioning.
Treatments and/or Procedures
Problem adaptation therapy PATH
Problem Adaptation Therapy (PATH) focuses on the subject, the caregiver, and the subject's home-environment, to encourage problem-solving and adaptive functioning. The goal of PATH is to decrease depression and disability.
Supportive therapy
Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Depression
The primary objective is to compare the efficacy of Problem Adaptation Therapy vs. Supportive Therapy in reducing depressive symptoms over a 12-week treatment period among elders with major depression, cognitive impairment, and disability.
Secondary
Disability
A secondary objective is to compare the efficacy of Problem Adaptation Therapy vs. Supportive Therapy in reducing disability over a 12-week treatment period among elders with major depression, cognitive impairment, and disability.
Study Criteria
Inclusion Criteria
1. Age: >64 (65 years and older).
2. Diagnosis: Major depression, unipolar as determined by the Structured Clinical
Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID), using
Diagnostic and Statistical Manual for Mental Disorders (DSM)IV criteria.
3. Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18.
4. Disability, i.e. impairment in at least 1 Instrumental Activity of Daily Living as
measured by Philadelphia Multilevel Assessment Instrument - Instrumental Activities of
Daily Living subscale (MAI-IADL).
5. Evidence of at least mild cognitive impairment but not severe impairment (Dementia
Rating Scale (DRS) total score between 90 and 133 inclusive).
6. Caregiver (family member or professional) able and willing to participate in
treatment.
7. Off antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for
12 weeks and no medical recommendation for change of these agents in the near future.
8. Command of English sufficient to participate in therapy and research assessments.
Exclusion Criteria
1. High suicide risk, i.e. intent or plan to attempt suicide in near future.
2. Axis I psychiatric disorder or substance abuse other than unipolar major depression,
non-psychotic depression.
3. Axis II diagnosis of antisocial personality as determined by the SCID personality
disorder section (using DSM-IV criteria).
4. Moderate to Severe Dementia: We will exclude participants with DRS Total Score
corresponding to moderate or more severe dementia (DRS Total <=90).
5. Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated
cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction
during the three months prior to entry); drugs known to cause depression (e.g.,
reserpine, alpha-methyl-dopa, steroids); or chronic addictive drug use.
6. Current involvement in psychotherapy.
7. Aphasia.
