Retaining Cognition While Avoiding Late-Life Depression (RECALL)

November 10, 2017 updated by: Meryl Butters, University of Pittsburgh

RECALL: Retaining Cognition While Avoiding Late-Life Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Western Psychiatric Institute and Clinic
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Late-Life Evaluation and Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

MCI participant 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.

MCI participant 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

Support person Inclusion Criteria:

  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.

Support person 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Problem Solving Therapy
8-12 sessions of Problem Solving Therapy (both members of dyad)
Behavioral: Problem Solving Therapy
6-12 sessions of Problem Solving Therapy (both members of dyad)
Active Comparator: Problem Solving Therapy + Exercise
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Behavioral: Problem Solving Therapy + Exercise
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Active Comparator: 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of depression or anxiety disorders
Time Frame: 15 months
PHQ9, prime-MD SCID, GAD7
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function measured by RBANS and DKEFS
Time Frame: 15 months
RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ariel Gildengers, MD, University of Pittsburgh
  • Principal Investigator: Meryl Butters, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10110050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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