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Retaining Cognition While Avoiding Late-Life Depression (RECALL)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Therapy
Problem Solving Therapy + Exercise
Enhanced Usual Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, memory impairment, problem-solving therapy, depression prevention, caregiver stress, exercise

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Late-Life Evaluation and Treatment Center
  • UPMC Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Problem Solving Therapy

Problem Solving Therapy + Exercise

Enhanced Usual Care

Arm Description

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

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

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).

Outcomes

Primary Outcome Measures

Incidence of depression or anxiety disorders
PHQ9, prime-MD SCID, GAD7

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2013
Last Updated
November 10, 2017
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01886586
Brief Title
Retaining Cognition While Avoiding Late-Life Depression
Acronym
RECALL
Official Title
RECALL: Retaining Cognition While Avoiding Late-Life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, memory impairment, problem-solving therapy, depression prevention, caregiver stress, exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem Solving Therapy
Arm Type
Active Comparator
Arm Description
8-12 sessions of Problem Solving Therapy (both members of dyad)
Arm Title
Problem Solving Therapy + Exercise
Arm Type
Active Comparator
Arm Description
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy
Intervention Description
6-12 sessions of Problem Solving Therapy (both members of dyad)
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy + Exercise
Intervention Description
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of depression or anxiety disorders
Description
PHQ9, prime-MD SCID, GAD7
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Change in cognitive function measured by RBANS and DKEFS
Description
RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
MCI participant Inclusion Criteria: => age 60 Modified Mini Mental State (3MS) => 80 MCI diagnosis Adequate physical and sensory function to undergo NP assessment PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed. MCI participant Exclusion Criteria: Major Depressive Episode or anxiety disorder within the past 1 year Currently taking an anti-depressant History of Bipolar Disorder or Schizophrenia Drug or alcohol use disorder within 12 months Currently taking anti-anxiety med >4x/week for the past 4 weeks Support person Inclusion Criteria: => age 18 Modified Mini Mental State (3MS) => 80 Normal Cognitive Function Adequate physical and sensory function to undergo NP assessment PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed. Support person Exclusion Criteria: Major Depressive Episode or anxiety disorder within the past 1 year Currently taking an anti-depressant History of Bipolar Disorder or Schizophrenia Drug or alcohol use disorder within 12 months Currently taking anti-anxiety med >4x/week for the past 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryl Butters, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariel Gildengers, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Late-Life Evaluation and Treatment Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27066730
Citation
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.
Results Reference
derived
Links:
URL
http://www.imanagestress.org/
Description
iManage studies website

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Retaining Cognition While Avoiding Late-Life Depression

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