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Retaining Cognition While Avoiding Late-Life Depression (RECALL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886586
First Posted: June 26, 2013
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Meryl Butters, University of Pittsburgh
  Purpose
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.

Condition Intervention
Mild Cognitive Impairment Behavioral: Problem Solving Therapy Behavioral: Problem Solving Therapy + Exercise Other: Enhanced Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RECALL: Retaining Cognition While Avoiding Late-Life Depression

Further study details as provided by Meryl Butters, University of Pittsburgh:

Primary Outcome Measures:
  • Incidence of depression or anxiety disorders [ Time Frame: 15 months ]
    PHQ9, prime-MD SCID, GAD7


Secondary Outcome Measures:
  • 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


Enrollment: 94
Study Start Date: July 2011
Study Completion Date: July 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886586


Locations
United States, Pennsylvania
UPMC Late-Life Evaluation and Treatment Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Meryl Butters, MD University of Pittsburgh
Principal Investigator: Ariel Gildengers, MD University of Pittsburgh
  More Information

Additional Information:
Responsible Party: Meryl Butters, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01886586     History of Changes
Other Study ID Numbers: 10110050
First Submitted: June 21, 2013
First Posted: June 26, 2013
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Meryl Butters, University of Pittsburgh:
Mild Cognitive Impairment
memory impairment
problem-solving therapy
depression prevention
caregiver stress
exercise

Additional relevant MeSH terms:
Depression
Cognitive Dysfunction
Behavioral Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders