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Completed

NCT Number: NCT01886586

Retaining Cognition While Avoiding Late-Life Depression

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.

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Key information

Conditions

Mild Cognitive Impairment Behavior Behavioral Symptoms Caregiver Burden Cognition Disorders Cognitive Dysfunction Memory Disorders Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

MCI participant Inclusion Criteria:

  • => 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.

MCI participant Exclusion Criteria:

  • 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

Support person Inclusion Criteria:

  • => 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.

Support person Exclusion Criteria:

  • 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

Treatment and study plan

Problem solving therapy

Behavioral

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

Problem Solving Therapy + Exercise

Behavioral

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

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).

Primary outcomes

  1. Incidence of depression or anxiety disorders

    Time frame: 15 months

    PHQ9, prime-MD SCID, GAD7

Secondary outcomes

  1. Change in cognitive function measured by RBANS and DKEFS

    Time frame: 15 months

    RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Cornell Services Index, P-GIC, ZARIT, DAS

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

RECALL: Retaining Cognition While Avoiding Late-Life Depression

Acronym: RECALL

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2013
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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