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

NCT00368940 | Completed Results

• 3 other identifiers: K23MH0746590301005971DATR AK-TNGP2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Memory Deficits; Geriatric Depression; Cognitive Impairment; Executive Dysfunction; Disability; Problem Solving Therapy

Outcome Measures

Primary Outcomes (2)

• Montgomery Asberg Depression Scale (MADRS)

  Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).

  12 week outcome

• WHO Disability Assessment Schedule (WHODAS)-II

  WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).

  12-week outcome

Secondary Outcomes (2)

• Hamilton Depression Rating Scale

  Outcome at 12 weeks

• Sheehan Disability Scale.

  Outcome at 12 weeks

Study Arms (2)

PATH

EXPERIMENTAL

Participants will receive PATH for 12 weeks

Behavioral: PATH

ST-CI

ACTIVE COMPARATOR

Participants will receive ST-CI for 12 weeks

Behavioral: ST-CI

Interventions

PATH 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.

PATH

ST-CI 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.

Also known as: Supportive Therapy for Cognitively Impaired Older Adults

ST-CI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Cornell Institute of Geriatric Psychiatry

White Plains, New York, 10605, United States

Location

Related Publications (4)

• 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.

  PMID: 31910916 DERIVED

• 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.

  PMID: 31582195 DERIVED

• 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.

  PMID: 28223082 DERIVED

• 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.

  PMID: 25372657 DERIVED

MeSH Terms

Conditions

Depression; Memory Disorders; Cognitive Dysfunction

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dimitris N. Kiosses, Ph.D.
• Organization: Weill Cornell Medicine

dkiosses@med.cornell.edu

914-997-4381

Study Officials

• Dimitris N. Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2006
• First Posted: August 29, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-04

Locations

US (1)