Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Treatments problem solving therapy, problem solving therapy + exercise, enhanced usual care
Sponsor University of Pittsburgh
Collaborator National Institute of Mental Health (NIMH)
Start date July 2011
End date June 2016
Trial size 136 participants
Trial identifier NCT01886586, 10110050

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
8-12 sessions of Problem Solving Therapy (both members of dyad)
problem solving therapy
6-12 sessions of Problem Solving Therapy (both members of dyad)
(Active Comparator)
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
problem solving therapy + exercise
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
(Active Comparator)
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).
enhanced 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).

Primary Outcomes

Measure
Incidence of depression or anxiety disorders
time frame: 15 months

Secondary Outcomes

Measure
Change in cognitive function measured by RBANS and DKEFS
time frame: 15 months

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title RECALL: Retaining Cognition While Avoiding Late-Life Depression
Principal investigator Meryl Butters, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.