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Mild Cognitive ImpairmentRECALLNCT01886586

Retaining Cognition While Avoiding Late-Life Depression

A study testing Problem Solving Therapy and Problem Solving Therapy + Exercise in people with Mild Cognitive Impairment, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Problem Solving Therapy and Problem Solving Therapy + Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
2 sitesUnited States
Study dates
Jul 2011to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UPMC Late-Life Evaluation and Treatment Center

    Pittsburgh, Pennsylvania, 15213

  • UPMC Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: RECALL: 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.

Read the 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.

Being tested
Problem Solving Therapy, Problem Solving Therapy + Exercise, Enhanced Usual Care
Keywords
Mild Cognitive Impairment, memory impairment, problem-solving therapy, depression prevention, caregiver stress, exercise
Medical subject headings
Cognitive Dysfunction, Memory Disorders, Caregiver Burden, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem Solving TherapyBehavioural

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

  • Problem Solving Therapy + ExerciseBehavioural

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

  • Enhanced Usual CareOther

    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).

Study groups in NCT01886586
Study groupRoleWhat they receive
Problem Solving TherapyActive comparator8-12 sessions of Problem Solving Therapy (both members of dyad)
Receives: Behavioral: Problem Solving Therapy
Problem Solving Therapy + ExerciseActive comparator6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
Receives: Behavioral: Problem Solving Therapy + Exercise
Enhanced Usual CareActive comparatorStaff 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).
Receives: Other: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of depression or anxiety disorders

    PHQ9, prime-MD SCID, GAD7

    Measured: 15 months

Secondary outcomes (1)

  1. 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

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01886586
Sponsor's protocol ID
10110050
Acronym
RECALL
Status last verified
Nov 2017
First submitted
21 Jun 2013
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27066730

Questions about this trial

What is this clinical trial studying?

A study testing Problem Solving Therapy and Problem Solving Therapy + Exercise in people with Mild Cognitive Impairment, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of depression or anxiety disorders (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01886586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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