San Francisco, California 94143


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

ROI MH101472


NCT ID:

NCT02440815


Secondary ID:


Study Acronym:


Brief Title:

Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression


Official Title:

Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

110


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Scott Mackin, PhD
Principal Investigator
UCSF Department of Psychiatry
Primary Contact:Cara Woodworth, BA
415-476-7067
Cara.Woodworth@ucsf.edu
Backup Contact:David Bickford, BA
415-476-6618
David.Bickford@ucsf.edu

Study Dates

Start Date:November 2015
Completion Date:May 2020
Completion Type:Anticipated
Primary Completion Date:May 2020
Primary Completion Type:Anticipated
Verification Date:December 2018
Last Changed Date:December 11, 2018
First Received Date:May 6, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Rate of change in expressive language as measured by the Boston Naming Test using total correct.
Time Frame:Baseline, after 12 weeks of psychotherapy
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Rate of change in Depression Severity as measured by the Hamilton Depression Rating Scale (24 item).
Time Frame:Baseline, after 12 weeks of psychotherapy
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Rate of change in Subcortical White Matter Lesion as measured by WML-T2 FLAIR
Time Frame:Baseline, after 12 weeks of psychotherapy
Safety Issues:False
Description:Subcortical White Matter Lesion will be measured using multimodal MRI processing [structural T2-weighted Fluid Attenuated Inversion Recovery (FLAIR)].
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Cortical Gray Matter Atrophy will be measured using multimodal MRI processing (T1-MRI FreeSurfer image analysis suite version 5.1).
Outcome Type:Primary Outcome
Measure:Rate of change in Cerebral Blood Flow (CBF) as measured by cortical surface-based analysis
Time Frame:Baseline, after 12 weeks of psychotherapy
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Behavioral
Name:Problem Solving Therapy
Description: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.
Arm Name:Problem Solving Therapy

Study Arms

Study Arm Type:Other
Arm Name:Problem Solving Therapy
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:San Francisco Veterans Affairs Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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