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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00368940
First received: August 25, 2006
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Depression
Behavioral: PATH
Behavioral: Supportive Therapy for Cognitively Impaired Older Adults (ST-CI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Treatment for Depressed, Cognitively Impaired Elders

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Montgomery Asberg Depression Scale (MADRS) [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • WHO Disability Assessment Schedule (WHODAS)-II [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Measured at Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2006
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive PATH for 12 weeks
Behavioral: PATH
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: 2
Participants will receive ST-CI for 12 weeks
Behavioral: 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.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368940

Locations
United States, New York
Cornell Institute of Geriatric Psychiatry
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Dimitris N. Kiosses, PhD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00368940     History of Changes
Other Study ID Numbers: K23 MH074659, K23MH074659, 0301005971, DATR AK-TNGP2
Study First Received: August 25, 2006
Last Updated: March 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Memory Deficits
Geriatric Depression
Cognitive Impairment
Executive Dysfunction
Disability
Problem Solving Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014