Retaining Cognition While Avoiding Late-Life Depression

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Problem Solving Therapy + Exercise; Behavioral: Problem Solving Therapy; Other: Enhanced Usual Care

• Registration Number: NCT01886586
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Problem Solving Therapy + Exercise	Problem Solving Therapy + Exercise	6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Problem Solving Therapy	Problem Solving Therapy	8-12 sessions of Problem Solving Therapy (both members of dyad)
Enhanced Usual Care	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).

Primary Outcome Measures

Name	Time	Method
Incidence of depression or anxiety disorders	15 months	PHQ9, prime-MD SCID, GAD7

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function measured by RBANS and DKEFS	15 months	RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS

Trial Locations

Locations (2)

UPMC Late-Life Evaluation and Treatment Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States