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Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression

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ClinicalTrials.gov Identifier: NCT02440815
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
Scott Mackin, PhD, University of California, San Francisco

Brief Summary:
The specific focus of this study is to gather data regarding the effects of a psychological therapy known as Problem Solving Therapy (PST) on cerebral blood flow (CBF), cortical gray matter (GM) atrophy, subcortical white matter (WM) lesion burden, and measures of cognitive function in subjects with Late Life Major Depressive Disorder (LLD). This research goal will be achieved by recruiting 110 individuals over the age of 65 with LLD. The primary outcomes will be change in CBF, change in GM atrophy, change in WM lesion, change in cognitive function, and change in depression severity from baseline to the end of 12 weeks of PST.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Problem Solving Therapy Not Applicable

Detailed Description:

Study procedures include: 1) Telephone screen, 2) Diagnostic evaluation to determine diagnosis of MDD, 3) Baseline evaluation consisting of medical history, cognitive assessment, and MRIs, 4) Participation in 12 weeks of psychotherapy treatment with assessments of depression severity, and 5) Follow up evaluation at 12 weeks consisting of depression, cognitive function, and post treatment MRIs.

Telephone Screen: Older adults who respond to our recruitment efforts for LLD will be screened by telephone using the Patient Health Questionnaire (PHQ-9) and those who obtain a score of 5 or greater will be scheduled for an eligibility appointment within a week of screening. Anyone who endorses the suicide question (item 9) of the PHQ-9 will be scheduled for a same day appointment, and will be seen by the study investigators. Similarly, other exclusion criteria will be assessed using a structured questionnaire. If participants are interested in other treatment referrals these will be provided.

Diagnostic Evaluation: In this assessment, the investigators consent participants and administer measures that address eligibility [i.e., Structured Clinical Interview for Diagnosis of DSM-IV Disorders (SCID)], the 24 item HDRS, Mini Mental Status Exam (MMSE), Clinical Dementia Rating Scale (CDR). To qualify, LLD participants must obtain a diagnosis of MDD (SCID), have an HDRS score of 20 or higher, a MMSE score of 25 or better, and a CDR of 0.5 or less.. Those who do not qualify for the study and/or who are interested in alternate LLD treatments will be offered referrals for services at the outpatient clinics at UCSF or community resources.

Baseline Assessment: After completion of the diagnostic evaluation and being deemed study eligible, LLD participants will be scheduled for a baseline assessment. At the baseline assessment meeting, the HDRS is administered again to confirm depression severity. The baseline assessment consists of 1) demographics and patient characteristics, 2) neuropsychological testing, and 3) depression and functional outcome measures, and 4) multimodal MRI evaluation.

Participant Characteristics: Demographic data, such as age, gender, race, living conditions, marital status, occupation, and education will be obtained as well as previous psychiatric treatment received. Medical comorbidity will be assessed using the Charlson Comorbidity Index (CCI). Medication use will be assessed using the Alzheimer's Disease Neuroimaging Initiative (ADNI) medication history form. Suicidal ideation will be assessed utilizing the Scale for Suicidal Ideation (SSI). The investigators will utilize a clinician rated measures of lifetime history of depressive episodes and depression treatments, the Duke Social Support Index, and the Functional Activities Questionnaire (FAQ) for exploratory analyses.

Cognitive Functioning: Primary cognitive outcome variables will include: the Digit Symbol Substitution Test, the Boston Naming test, and the Rey Auditory Verbal Learning Test as a measure of memory.

Psychotherapeutic Treatment: Problem Solving Therapy (PST) is a brief evidence based psychotherapy that is commonly utilized for treatment of LLD. The problem solving therapy includes 12 weekly in person 50 minute sessions.

Follow up assessments: At 12 weeks, LLD participants will participate in a follow up evaluation that is identical the baseline assessment of depression, cognitive function, and MRI. The investigators will use total HDRS score to determine response to treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression
Actual Study Start Date : November 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Problem Solving Therapy
Problem Solving Therapy (PST) is a brief evidence based psychotherapy that is commonly utilized for treatment of LLD. The problem solving therapy includes 12 weekly in person 50 minute sessions.
Behavioral: Problem Solving Therapy
Problem Solving Therapy (PST) is a brief evidence based psychotherapy that is commonly utilized for treatment of LLD. The problem solving therapy includes 12 weekly in person 50 minute sessions.




Primary Outcome Measures :
  1. Rate of change in Cerebral Blood Flow (CBF) as measured by cortical surface-based analysis [ Time Frame: Baseline, after 12 weeks of psychotherapy ]
    CBF will be measured using multimodal MRI processing (individual 2D pseudo ASL image frames). We will pursue a cortical surface-based analysis approach which allows for better spatial normalization of cortical data compared to voxel-based approaches.

  2. Rate of change in Cortical Gray Matter (GM) Atrophy as measured by the FreeSurfer image analysis suite [ Time Frame: Baseline, after 12 weeks of psychotherapy ]
    Cortical Gray Matter Atrophy will be measured using multimodal MRI processing (T1-MRI FreeSurfer image analysis suite version 5.1).

  3. Rate of change in Subcortical White Matter Lesion as measured by WML-T2 FLAIR [ Time Frame: Baseline, after 12 weeks of psychotherapy ]
    Subcortical White Matter Lesion will be measured using multimodal MRI processing [structural T2-weighted Fluid Attenuated Inversion Recovery (FLAIR)].

  4. Rate of change in Depression Severity as measured by the Hamilton Depression Rating Scale (24 item). [ Time Frame: Baseline, after 12 weeks of psychotherapy ]
  5. Rate of change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct [ Time Frame: Baseline, after 12 weeks of psychotherapy ]
  6. Rate of change in expressive language as measured by the Boston Naming Test using total correct. [ Time Frame: Baseline, after 12 weeks of psychotherapy ]
  7. Rate of change in learning and memory as measured by the Rey Auditory Verbal Learning Test using total correct and delayed recall. [ Time Frame: Baseline, after 12 weeks of psychotherapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current DSM-IV diagnosis of MDD, unipolar type, without psychotic features and 6 weeks minimum duration of current depressive episode.
  2. Moderate severity of depression using the Hamilton Depression Rating Scale (HDRS > 20).
  3. English speaking, male or female
  4. 65 years of age or older
  5. Good general health
  6. Able to give informed consent

Exclusion Criteria:

  1. Antidepressant use or psychotherapy within the past 6 weeks or electroconvulsive therapy within the past 6 months.
  2. Recent history (<6 months) of substance or alcohol abuse or dependence (DSM-IV criteria).
  3. Use of cognitive enhancing medications.
  4. Current diagnosis of Post-Traumatic Stress Disorder or other Axis 1 psychiatric disorder.
  5. Neurological diseases (e.g., Parkinson's disease, epilepsy, cortical stroke, Alzheimer's disease, traumatic brain injury) or dementia.
  6. History of surgical procedures affecting study outcomes.
  7. Contraindications for MR exam, i.e., no claustrophobia, no paramagnetic metal implants, able to fit in the MRI machine comfortably (BMI ≤ 38).
  8. Acute or uncontrolled medical illness or medication use impacting cognitive function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440815


Contacts
Contact: Kelly Scherer, BS 415-476-7067 Kelly.Scherer@ucsf.edu
Contact: Kelly Scherer, BS 415-476-7046 Kelly.Scherer@uscf.edu

Locations
United States, California
University of California, San Francisco, Langley Porter Psychiatric Institute Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Scott Mackin, PhD         
Sub-Investigator: Duygu Tosun, PhD         
Sub-Investigator: Michael W Weiner, MD         
Sub-Investigator: Craig Nelson, MD         
Sub-Investigator: Derek Satre, PhD         
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
Investigators
Principal Investigator: Scott Mackin, PhD UCSF Department of Psychiatry

Responsible Party: Scott Mackin, PhD, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02440815     History of Changes
Other Study ID Numbers: ROI MH101472
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Scott Mackin, PhD, University of California, San Francisco:
Psychotherapy
Problem Solving Therapy (PST)
Depression
Major Depression
Major Depressive Disorder
Late Life Depression
Multimodal imaging
Magnetic Resonance Imaging (MRI)
Cerebral blood flow
Cortical atrophy
White matter lesion

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders