Clinical trial NCT01886586: Retaining Cognition While Avoiding Late-Life Depression
Official title: RECALL: Retaining Cognition While Avoiding Late-Life Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
memory impairment
problem-solving therapy
depression prevention
caregiver stress
exercise
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-06-26
Enrollment: 94
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of depression or anxiety disorders
timeFrame: 15 months
Secondary outcomes:
measure: Change in cognitive function measured by RBANS and DKEFS
timeFrame: 15 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Late-Life Evaluation and Treatment Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Meryl Butters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ariel Gildengers, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.