RECALL: Retaining Cognition While Avoiding Late-Life Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 94
- Locations
- 2
- Primary Endpoint
- Incidence of depression or anxiety disorders
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •MCI participant Inclusion Criteria:
- •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:
- •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
Arms & Interventions
Problem Solving Therapy
8-12 sessions of Problem Solving Therapy (both members of dyad)
Intervention: Problem Solving Therapy (Behavioral)
Problem Solving Therapy + Exercise
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Intervention: Problem Solving Therapy + Exercise (Behavioral)
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).
Intervention: Enhanced Usual Care (Other)
Outcomes
Primary Outcomes
Incidence of depression or anxiety disorders
Time Frame: 15 months
PHQ9, prime-MD SCID, GAD7
Secondary Outcomes
- Change in cognitive function measured by RBANS and DKEFS(15 months)
Investigators
Meryl Butters
Associate Professor
University of Pittsburgh