Retaining Cognition While Avoiding Late-Life Depression (RECALL)

University of Pittsburgh

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Problem Solving Therapy; Other: Enhanced Usual Care; Behavioral: Problem Solving Therapy + Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01886586

10110050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 3 patient groups

Problem Solving Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Problem Solving Therapy

Problem Solving Therapy + Exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Problem Solving Therapy + Exercise

Enhanced Usual Care

Active Comparator group

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).

Treatment:

Other: Enhanced Usual Care