deltatrials
Completed NA INTERVENTIONAL 1-arm NCT02440815

Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression (PRS)

Sponsor: San Francisco Veterans Affairs Medical Center

Updated 11 times since 2017 Last updated: Jul 28, 2021 Started: Nov 30, 2015 Primary completion: Jul 28, 2021 Completion: Jul 28, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Major Depressive Disorder and is currently completed. San Francisco Veterans Affairs Medical Center leads this study, which shows 11 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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),...

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotNot Yet Recruiting~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshotNot Yet Recruiting~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotRecruiting~Jan 2019 – ~Feb 2020 · 13 months · monthly snapshotRecruiting~Feb 2020 – ~Sep 2020 · 7 months · monthly snapshotRecruiting~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Sep 2021 — Jul 2024 [monthly]

    Completed NA

    Status: RecruitingCompleted

  4. Jan 2021 — Sep 2021 [monthly]

    Recruiting NA

  5. Sep 2020 — Jan 2021 [monthly]

    Recruiting NA

Show 6 earlier versions
  1. Feb 2020 — Sep 2020 [monthly]

    Recruiting NA

  2. Jan 2019 — Feb 2020 [monthly]

    Recruiting NA

  3. Jun 2018 — Jan 2019 [monthly]

    Recruiting NA

  4. Dec 2017 — Jun 2018 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  5. Feb 2017 — Dec 2017 [monthly]

    Not Yet Recruiting NA

  6. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting NA

    First recorded

Nov 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • San Francisco Veterans Affairs Medical Center
  • University of California, San Francisco
Data source: University of California, San Francisco

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations