Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults

Not Applicable

Completed

Conditions: Depression

Interventions: Behavioral: PATH
Behavioral: ST-CI

Registration Number: NCT00368940

Lead Sponsor: Weill Medical College of Cornell University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PATH	PATH	Participants will receive PATH for 12 weeks
ST-CI	ST-CI	Participants will receive ST-CI for 12 weeks

Primary Outcome Measures

Name	Time	Method
WHO Disability Assessment Schedule (WHODAS)-II	12-week outcome	WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).
Montgomery Asberg Depression Scale (MADRS)	12 week outcome	Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).

Secondary Outcome Measures

Name	Time	Method
Sheehan Disability Scale.	Outcome at 12 weeks	Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).
Hamilton Depression Rating Scale	Outcome at 12 weeks	Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).