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Retaining Cognition While Avoiding Late-Life Depression

RECALL: Retaining Cognition While Avoiding Late-Life Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01886586
Acronym
RECALL
Enrollment
94
Registered
2013-06-26
Start date
2011-07-31
Completion date
2016-07-31
Last updated
2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

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

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.

Interventions

BEHAVIORALProblem Solving Therapy

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

BEHAVIORALProblem Solving Therapy + Exercise

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

OTHEREnhanced 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).

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of depression or anxiety disorders15 monthsPHQ9, prime-MD SCID, GAD7

Secondary

MeasureTime frameDescription
Change in cognitive function measured by RBANS and DKEFS15 monthsRBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026