This trial is active, not recruiting.

Condition depression
Treatments path, supportive therapy for cognitively impaired older adults (st-ci)
Sponsor Weill Medical College of Cornell University
Collaborator National Institute of Mental Health (NIMH)
Start date April 2006
End date August 2014
Trial size 120 participants
Trial identifier NCT00368940, 0301005971, DATR AK-TNGP2, K23 MH074659, K23MH074659


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Participants will receive PATH for 12 weeks
PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
(Active Comparator)
Participants will receive ST-CI for 12 weeks
supportive therapy for cognitively impaired older adults (st-ci)
Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.

Primary Outcomes

Montgomery Asberg Depression Scale (MADRS)
time frame: Measured at Weeks 4, 8, 12, and 24
WHO Disability Assessment Schedule (WHODAS)-II
time frame: Measured at Weeks 4, 8, 12, and 24

Secondary Outcomes

Hamilton Depression Rating Scale
time frame: Measured at Weeks 4, 8, 12, and 24
Sheehan Disability Scale
time frame: Measured at Weeks 4, 8, 12, and 24

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title A Treatment for Depressed, Cognitively Impaired Elders
Principal investigator Dimitris N. Kiosses, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.