Retaining Cognition While Avoiding Late-Life Depression

Mild Cognitive Impairment Clinical Trial

— RECALL  

Official title:

RECALL: Retaining Cognition While Avoiding Late-Life Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886586
• Other study ID #: 10110050
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: November 10, 2017
• Start date: July 2011
• Est. completion date: July 2016

Study information

• Verified date: November 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Mild Cognitive Impairment

Intervention

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

Other:
• 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).

Locations

Country	Name	City	State
United States	UPMC Late-Life Evaluation and Treatment Center	Pittsburgh	Pennsylvania
United States	UPMC Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of depression or anxiety disorders	PHQ9, prime-MD SCID, GAD7	15 months
Secondary	Change in cognitive function measured by RBANS and DKEFS	RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS	15 months

External Links

•   iManage studies website