Retaining Cognition While Avoiding Late-Life Depression

Study Overview
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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.

Official Title
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RECALL: Retaining Cognition While Avoiding Late-Life Depression

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Problem Solving Therapy
* Behavioral: Problem Solving Therapy + Exercise
* Other: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Problem Solving Therapy<br>8-12 sessions of Problem Solving Therapy (both members of dyad) | Behavioral: Problem Solving Therapy<br>* 6-12 sessions of Problem Solving Therapy (both members of dyad)<br>|
| Active Comparator: Problem Solving Therapy + Exercise<br>6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad) | Behavioral: Problem Solving Therapy + Exercise<br>* 6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)<br>|
| Active Comparator: Enhanced Usual Care<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of depression or anxiety disorders | 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 | RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, Mild Cognitive Impairment, memory impairment, problem-solving therapy, depression prevention, caregiver stress