Prevention of Depression in Spouses of People With Cognitive Impairment

NCT00321971 | Completed Results DMC

• 1 other identifier: K23MH070719
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effectiveness of a problem-solving training program in preventing depression in the spouses or family caregivers of persons with mild cognitive impairment or early dementia.

Conditions

Depression

Keywords

Anxiety; Mild Cognitive Impairment; MCI; Cognitive Impairment; Alzheimer's Disease; Caregiver Burden; Caregiver Stress; Family Dementia Caregiving; Spousal Dementia Caregiving

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms

  Depressive symptoms were measured with Center for Epidemiological Studies - Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach's alpha = .88) and predictive validity for the diagnosis of depression.

  Baseline and 1-, 3-, 6-, and 12- months post-treatment

Study Arms (2)

PST-MCI/AD Caregiving

EXPERIMENTAL

The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It was adapted from a manualized protocol for PST use in primary care. Our adaptation sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressor.

Behavioral: PST-MCI/AD Caregiving

NT-MCI/AD Caregiving

ACTIVE COMPARATOR

The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the United States Department of Health and Human Services (USDHHS) "2005 My Pyramid Dietary Guidelines for Americans over Age 50." We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.

Behavioral: NT-MCI/AD Caregiving

Interventions

PST-MCI/AD Caregiving BEHAVIORAL

The PST-based intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.

PST-MCI/AD Caregiving

NT-MCI/AD Caregiving BEHAVIORAL

The nutritional education program will be based on the new USSDA dietary recommendations. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.

NT-MCI/AD Caregiving

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spouse or non-married partner of a patient being treated at the University of Pittsburgh Alzheimer's Disease Research Center (ADRC) for a new or subsequent diagnosis of MCI

You may not qualify if:

• Does not speak English
• Cohabitating adult child of a person with MCI
• Resides in an institutional or assisted-living setting

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Pittsburgh Alzheimer's Disease Research Center (ADRC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Duquesne Univeristy

Pittsburgh, Pennsylvania, 15282, United States

Location

Related Publications (3)

• Garand L, Dew MA, Eazor LR, DeKosky ST, Reynolds CF 3rd. Caregiving burden and psychiatric morbidity in spouses of persons with mild cognitive impairment. Int J Geriatr Psychiatry. 2005 Jun;20(6):512-22. doi: 10.1002/gps.1318.

  PMID: 15920711 BACKGROUND

• Garand L, Rinaldo DE, Alberth MM, Delany J, Beasock SL, Lopez OL, Reynolds CF 3rd, Dew MA. Effects of problem solving therapy on mental health outcomes in family caregivers of persons with a new diagnosis of mild cognitive impairment or early dementia: a randomized controlled trial. Am J Geriatr Psychiatry. 2014 Aug;22(8):771-81. doi: 10.1016/j.jagp.2013.07.007. Epub 2013 Oct 8.

  PMID: 24119856 RESULT

• Garand L, Morse JQ, ChiaRebecca L, Barnes J, Dadebo V, Lopez OL, Dew MA. Problem-solving therapy reduces subjective burden levels in caregivers of family members with mild cognitive impairment or early-stage dementia: Secondary analysis of a randomized clinical trial. Int J Geriatr Psychiatry. 2019 Jul;34(7):957-965. doi: 10.1002/gps.5095. Epub 2019 Apr 17.

  PMID: 30868641 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Cognitive Dysfunction; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Stress, Psychological

Limitations and Caveats

The relatively small size and racial composition of the sample was a limitation. The generalizability of our findings are reduced by our focus on family caregivers who reside with the individual with cognitive impairment.

Results Point of Contact

• Title: Linda Garand PhD
• Organization: Duquesne University School of Nursing

garandl@duq.edu

412-396-6543

Study Officials

• Linda J. Garand, PhD

  The University of Pittsburgh School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 4, 2006
• Study Start: February 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 3, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)