Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression

NCT02440815 | Completed DMC

• 1 other identifier: ROI MH101472
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Rate of change in Cerebral Blood Flow (CBF) as measured by cortical surface-based analysis

  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.

  Baseline, after 12 weeks of psychotherapy

• Rate of change in Cortical Gray Matter (GM) Atrophy as measured by the FreeSurfer image analysis suite

  Cortical Gray Matter Atrophy will be measured using multimodal MRI processing (T1-MRI FreeSurfer image analysis suite version 5.1).

  Baseline, after 12 weeks of psychotherapy

• Rate of change in Subcortical White Matter Lesion as measured by WML-T2 FLAIR

  Subcortical White Matter Lesion will be measured using multimodal MRI processing \[structural T2-weighted Fluid Attenuated Inversion Recovery (FLAIR)\].

  Baseline, after 12 weeks of psychotherapy

• Rate of change in Depression Severity as measured by the Hamilton Depression Rating Scale (24 item).

  Baseline, after 12 weeks of psychotherapy

• Rate of change in neuropsychological measures of executive function as measured by the Digit Symbol Substitution Test using total correct

  Baseline, after 12 weeks of psychotherapy

• Rate of change in expressive language as measured by the Boston Naming Test using total correct.

  Baseline, after 12 weeks of psychotherapy

• Rate of change in learning and memory as measured by the Rey Auditory Verbal Learning Test using total correct and delayed recall.

  Baseline, after 12 weeks of psychotherapy

Study Arms (1)

Problem Solving Therapy

OTHER

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

Interventions

Problem Solving Therapy BEHAVIORAL

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.

Problem Solving Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (1)

University of California, San Francisco, Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Scott Mackin, PhD

  UCSF Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 12, 2015
• Study Start: November 1, 2015
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

US (1)