Retaining Cognition While Avoiding Late-Life Depression

NCT01886586 | Completed DMC

• 1 other identifier: 10110050
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; memory impairment; problem-solving therapy; depression prevention; caregiver stress; exercise

Outcome Measures

Primary Outcomes (1)

• Incidence of depression or anxiety disorders

  PHQ9, prime-MD SCID, GAD7

  15 months

Secondary Outcomes (1)

• Change in cognitive function measured by RBANS and DKEFS

  15 months

Study Arms (3)

Problem Solving Therapy

ACTIVE COMPARATOR

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

Behavioral: Problem Solving Therapy

Problem Solving Therapy + Exercise

ACTIVE COMPARATOR

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

Behavioral: Problem Solving Therapy + Exercise

Enhanced Usual Care

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).

Other: Enhanced Usual Care

Interventions

Problem Solving Therapy BEHAVIORAL

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

Problem Solving Therapy

Problem Solving Therapy + Exercise BEHAVIORAL

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

Problem Solving Therapy + Exercise

Enhanced Usual Care OTHER

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).

Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• =\> age 60
• Modified Mini Mental State (3MS) =\> 80
• MCI diagnosis
• Adequate physical and sensory function to undergo NP assessment
• PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.

You may not qualify if:

• Major Depressive Episode or anxiety disorder within the past 1 year
• Currently taking an anti-depressant
• History of Bipolar Disorder or Schizophrenia
• Drug or alcohol use disorder within 12 months
• Currently taking anti-anxiety med \>4x/week for the past 4 weeks
• =\> age 18
• Modified Mini Mental State (3MS) =\> 80
• Normal Cognitive Function
• Adequate physical and sensory function to undergo NP assessment
• PHQ-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.
• Major Depressive Episode or anxiety disorder within the past 1 year
• Currently taking an anti-depressant
• History of Bipolar Disorder or Schizophrenia
• Drug or alcohol use disorder within 12 months
• Currently taking anti-anxiety med \>4x/week for the past 4 weeks

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

UPMC Late-Life Evaluation and Treatment Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 27066730 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders; Caregiver Burden; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Meryl Butters, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Ariel Gildengers, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 26, 2013
• Study Start: July 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

US (2)