Clinical trial NCT00368940: Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults
Official title: A Treatment for Depressed, Cognitively Impaired Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Memory Deficits
Geriatric Depression
Cognitive Impairment
Executive Dysfunction
Disability
Problem Solving Therapy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-08-29
Enrollment: 74
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability in treating depressed, cognitively impaired older adults.

Detailed description: Depression, cognitive impairment, and disability often coexist in older adults and can lead to patient suffering and family disruption. Moreover, many depressed, cognitively impaired older adults have slow, poor, or unstable response to antidepressant drugs. Despite the need for treatments other than medication, most psychotherapy research focuses on either cognitively intact patients with limited disability or on dementia patients with pronounced disability. Thus, the available treatments do not fully address the needs of the large number of depressed elders with intermediate cognitive impairment and disability. Previous studies with cognitively impaired psychiatric populations have taught participants compensatory strategies to overcome their behavioral and cognitive limitations. This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) a type of psychotherapy using a problem solving therapy (PST) approach, specially tailored compensatory strategies and environmental adaptations and caregiver involvement in treating depressed, cognitively impaired older adults.

All participants in this single-blind study will undergo initial evaluations, including a 2-hour interview to assess depression, memory, and physical functioning; questions about medical history; and a neuropsychological exam. Participants will then be randomly assigned to one of two treatment groups: PATH or ST-CI. Participants assigned to PATH will receive 12 weekly sessions conducted at the home of the participants. During these sessions, a therapist will identify the participant's difficulties in life related to depression and physical functioning and will provide strategies to overcome these difficulties. The goal of treatment is to improve adaptive functioning in the home environment, which in turn may reduce depression and disability. The first session will last between 1 and 2 hours, and the remaining 11 sessions will last 1 hour. Participants assigned to ST-CI will also receive 12 weekly treatment sessions with a therapist conducted at the home of the participants. During supportive therapy sessions, the therapist will help participants to express feelings and to focus on their strengths and abilities when working through difficulties and transitions. For all participants, initial assessments will be repeated at Weeks 4, 8, 12, and 24.

Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV criteria for unipolar major depression
* Severity of depression greater than or equal to 17 on MADRS
* Disability as determined by at least 1 impairment in instrumental activities of daily living
* Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory (\[scaled score less than 7\] adjusted for age and race based on Mayo's older participants normative data)
* Family member or caregiver able and willing to participate in treatment
* Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future

Exclusion Criteria:

* High suicide risk
* Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression
* Axis II diagnosis of antisocial personality
* Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5)
* Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry)
* Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
* Currently receiving psychotherapy
* Aphasia
* Sensory problems
* Inability to speak English

Primary outcomes:
measure: Montgomery Asberg Depression Scale (MADRS)
timeFrame: 12 week outcome
measure: WHO Disability Assessment Schedule (WHODAS)-II
timeFrame: 12-week outcome
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Outcome at 12 weeks
measure: Sheehan Disability Scale.
timeFrame: Outcome at 12 weeks
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Cornell Institute of Geriatric Psychiatry
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dimitris N. Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanellopoulos D, Rosenberg P, Ravdin LD, Maldonado D, Jamil N, Quinn C, Kiosses DN. Depression, cognitive, and functional outcomes of Problem Adaptation Therapy (PATH) in older adults with major depression and mild cognitive deficits. Int Psychogeriatr. 2020 Apr;32(4):485-493. doi: 10.1017/S1041610219001716. Epub 2020 Jan 8.
citation: Arslanoglou E, Banerjee S, Pantelides J, Evans L, Kiosses DN. Negative Emotions and the Course of Depression During Psychotherapy in Suicidal Older Adults With Depression and Cognitive Impairment. Am J Geriatr Psychiatry. 2019 Dec;27(12):1287-1295. doi: 10.1016/j.jagp.2019.08.018. Epub 2019 Aug 26.
citation: Kiosses DN, Gross JJ, Banerjee S, Duberstein PR, Putrino D, Alexopoulos GS. Negative Emotions and Suicidal Ideation during Psychosocial Treatments in Older Adults with Major Depression and Cognitive Impairment. Am J Geriatr Psychiatry. 2017 Jun;25(6):620-629. doi: 10.1016/j.jagp.2017.01.011. Epub 2017 Jan 19.
citation: Kiosses DN, Ravdin LD, Gross JJ, Raue P, Kotbi N, Alexopoulos GS. Problem adaptation therapy for older adults with major depression and cognitive impairment: a randomized clinical trial. JAMA Psychiatry. 2015 Jan;72(1):22-30. doi: 10.1001/jamapsychiatry.2014.1305.