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Retaining Cognition While Avoiding Late-Life Depression

NCT ID: NCT01886586

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-07-31

Brief Summary

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This study will adapt Problem Solving Therapy (PST) for individuals with mild cognitive impairment (MCI) as an intervention for preventing major depression (DEP). PST will be modified so as to be provided to both MCI probands as well as their support person. The primary aim is to examine the effectiveness of PST in individuals with MCI and the support person, at preventing DEP over 12 mos. in MCI probands. We also will examine the effect of exercise on preventing depression.

Detailed Description

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The Recall Study (Retaining Cognition while Avoiding Late-Life Depression) is a study for adults 60 and older who have noticed mild memory changes in themselves or a loved one. Mild memory changes may feel stressful and therefore increase an individual's risk of developing depression. This research project will test whether Problem Solving Therapy (PST) is successful in preventing major depression for those living with mild cognitive impairments. We will also examine the effect of modest exercise on mood. You will participate in 8 to 12 PST sessions over 16 weeks. All treatments are provided at no cost and there is compensation for participation.

Conditions

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Mild Cognitive Impairment

Keywords

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Mild Cognitive Impairment memory impairment problem-solving therapy depression prevention caregiver stress exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Problem Solving Therapy

8-12 sessions of Problem Solving Therapy (both members of dyad)

Group Type ACTIVE_COMPARATOR

Problem Solving Therapy

Intervention Type BEHAVIORAL

6-12 sessions of Problem Solving Therapy (both members of dyad)

Problem Solving Therapy + Exercise

6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)

Group Type ACTIVE_COMPARATOR

Problem Solving Therapy + Exercise

Intervention Type BEHAVIORAL

6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)

Enhanced Usual Care

Staff will will document and monitor all mental health treatment (e.g., medications that participant may be taking) and psychotherapy (e.g. counseling or social services).

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type OTHER

Staff will document and monitor all mental health treatment (e.g., medications that participant may be taking) and psychotherapy (e.g. counseling or social services).

Interventions

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Problem Solving Therapy

6-12 sessions of Problem Solving Therapy (both members of dyad)

Intervention Type BEHAVIORAL

Problem Solving Therapy + Exercise

6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)

Intervention Type BEHAVIORAL

Enhanced Usual Care

Staff will document and monitor all mental health treatment (e.g., medications that participant may be taking) and psychotherapy (e.g. counseling or social services).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. =\> age 60
2. Modified Mini Mental State (3MS) =\> 80
3. MCI diagnosis
4. Adequate physical and sensory function to undergo NP assessment
5. PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.


1. =\> age 18
2. Modified Mini Mental State (3MS) =\> 80
3. Normal Cognitive Function
4. Adequate physical and sensory function to undergo NP assessment
5. PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.

Exclusion Criteria

1. Major Depressive Episode or anxiety disorder within the past 1 year
2. Currently taking an anti-depressant
3. History of Bipolar Disorder or Schizophrenia
4. Drug or alcohol use disorder within 12 months
5. Currently taking anti-anxiety med \>4x/week for the past 4 weeks


1. Major Depressive Episode or anxiety disorder within the past 1 year
2. Currently taking an anti-depressant
3. History of Bipolar Disorder or Schizophrenia
4. Drug or alcohol use disorder within 12 months
5. Currently taking anti-anxiety med \>4x/week for the past 4 weeks
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Meryl Butters

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meryl Butters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Ariel Gildengers, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Late-Life Evaluation and Treatment Center

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Gildengers AG, Butters MA, Albert SM, Anderson SJ, Dew MA, Erickson K, Garand L, Karp JF, Lockovich MH, Morse J, Reynolds CF 3rd. Design and Implementation of an Intervention Development Study: Retaining Cognition While Avoiding Late-Life Depression (ReCALL). Am J Geriatr Psychiatry. 2016 Jun;24(6):444-54. doi: 10.1016/j.jagp.2015.10.010. Epub 2015 Nov 18.

Reference Type DERIVED
PMID: 27066730 (View on PubMed)

Other Identifiers

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10110050

Identifier Type: -

Identifier Source: org_study_id