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

NCT ID: NCT00368940

Last Updated: 2017-07-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PATH

Participants will receive PATH for 12 weeks

Group Type EXPERIMENTAL

PATH

Intervention Type BEHAVIORAL

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.

ST-CI

Participants will receive ST-CI for 12 weeks

Group Type ACTIVE_COMPARATOR

ST-CI

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Supportive Therapy for Cognitively Impaired Older Adults

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dimitris N. Kiosses, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Cornell Institute of Geriatric Psychiatry

White Plains, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31910916 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31582195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28223082 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25372657 (View on PubMed)

Other Identifiers

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K23MH074659

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0301005971

Identifier Type: -

Identifier Source: secondary_id

DATR AK-TNGP2

Identifier Type: -

Identifier Source: secondary_id

K23MH074659

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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