Major Depressive DisorderPRSNCT02440815
Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression
A study testing Problem Solving Therapy in people with Major Depressive Disorder, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 28 Jul 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
- 65 years of age or older
- Good general health
- Able to give informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco, Langley Porter Psychiatric Institute
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Problem Solving Therapy
- 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
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)].
Measured: Baseline, after 12 weeks of psychotherapy
Rate of change in Depression Severity as measured by the Hamilton Depression Rating Scale (24 item).
Measured: 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
Measured: Baseline, after 12 weeks of psychotherapy
Rate of change in expressive language as measured by the Boston Naming Test using total correct.
Measured: 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.
Measured: Baseline, after 12 weeks of psychotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startNov 2015
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Scott Mackin, PhD, Principal investigator, UCSF Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440815
- Sponsor's protocol ID
- ROI MH101472
- Acronym
- PRS
- Status last verified
- Jul 2021
- First submitted
- 6 May 2015
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression
- ClinicalTrials.gov ID
- NCT02440815
- Acronym / sponsor ID
- PRS / ROI MH101472
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- Nov 2015 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Therapy | Other | Behavioral: Problem Solving TherapyProblem 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
- 65 years of age or older
- Good general health
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving TherapyProblem 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. | Behavioural | Problem Solving Therapy |
Primary outcome
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.
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).
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)].
Rate of change in Depression Severity as measured by the Hamilton Depression Rating Scale (24 item).
Time frame: 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
Time frame: Baseline, after 12 weeks of psychotherapy
Rate of change in expressive language as measured by the Boston Naming Test using total correct.
Time frame: 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.
Time frame: Baseline, after 12 weeks of psychotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Mackin, PhD principal investigator
UCSF Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy in people with Major Depressive Disorder, run by University of California, San Francisco at 1 site 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?
The sponsor lists 6 inclusion and 8 exclusion criteria. 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of change in Cerebral Blood Flow (CBF) as measured by cortical surface-based analysis (time frame: Baseline, after 12 weeks of psychotherapy). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2021.