Trial record 7 of 95 for:    depression pittsburgh | Open Studies

Retaining Cognition While Avoiding Late-Life Depression (RECALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01886586
First received: June 21, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Problem Solving Therapy
Behavioral: Problem Solving Therapy + Exercise
Other: Enhanced Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RECALL: Retaining Cognition While Avoiding Late-Life Depression

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Incidence of depression or anxiety disorders [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    PHQ9, prime-MD SCID, GAD7


Secondary Outcome Measures:
  • Change in cognitive function measured by RBANS and DKEFS [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    RBANS, DKEFS, 3MS, PASS, CAMCI, CIRS-G, RAND-12, LLFDI, SPPB, PSQI, NRS, ISEL, PROMIS, Acornell Services Index, P-GIC, ZARIT, DAS


Estimated Enrollment: 136
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probelm Solving Therapy
8-12 sessions of Problem Solving Therapy (both members of dyad)
Behavioral: Problem Solving Therapy
6-12 sessions of Problem Solving Therapy (both members of dyad)
Active Comparator: Problem Solving Therapy + Exercise
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Behavioral: Problem Solving Therapy + Exercise
6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Active Comparator: 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).
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).

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886586

Contacts
Contact: Michelle Zmuda, BS 412-246-4687 zmudamd@upmc.edu
Contact: Shannon Evan, MS 412-246-6487 evansl@upmc.edu

Locations
United States, Pennsylvania
UPMC Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Meryl Butters, MS    412-246-5280    buttersma@upmc.edu   
Contact: Michelle Zmuda, BS    412-246-6487    zmudamd@upmc.edu   
Principal Investigator: Meryl Butters, MD         
Principal Investigator: Ariel Gildengers, MD         
UPMC Late-Life Evaluation and Treatment Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jacqueline Stack, MSN, APRN    412-246-6006    stackja@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Meryl Butters, MD University of Pittsburgh
Principal Investigator: Ariel Gildengers, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01886586     History of Changes
Other Study ID Numbers: 10110050
Study First Received: June 21, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Mild Cognitive Impairment
memory impairment
problem-solving therapy
depression prevention
caregiver stress
exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cognition Disorders
Mild Cognitive Impairment
Behavioral Symptoms
Mood Disorders
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on October 19, 2014