Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression

November 13, 2018 updated by: Ashok Seshadri, Mayo Clinic

Stress Management and Resiliency Training (SMART) Integrated Into Comprehensive Treatment of Major Depression: A Feasibility Study

The investigators are doing this research study to find out if the Stress Management and Resiliency Training (SMART) therapy will help subjects with their major depression treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators propose to conduct an initial feasibility study in a sample of patients in treatment for major depression using SMART. The intervention will be weekly group therapy session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of 6-8 research participants per group. There will be no comparison group. The investigators aim to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the homework assignments. Resilience will be measured with the Connor-Davidson resilience scale. Secondary outcomes will include subjective and objective clinical rating scales for major depression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attending the Mayo Clinic Depression Center and Behavioral Health Clinic at Mayo Clinic Health System, Austin, Minnesota
  • DSM-V diagnostic confirmation of major depressive disorder (MDD)
  • Baseline PHQ-9 scores in the range of ≥6-≤19, and HAMD-17 score 8-18, or QIDS-C16 score of 6-20
  • Able to speak English
  • Participants will continue taking any prescribed medications from their clinical treatment team
  • Patients with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.

Exclusion Criteria:

  • Participants with bipolar disorder
  • Active psychosis
  • Active suicidal ideations
  • Active substance abuse meeting criteria for substance use disorders except nicotine
  • Obsessive compulsive disorder
  • Active Panic disorder with agoraphobia, other phobic disorder
  • Active Posttraumatic stress disorder
  • Active Severe personality disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Depressed Subjects
Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
Behavioral: Stress Management and Resiliency Training
Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.
Other Names:
  • SMART

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Connor-Davidson Resilience Scale Score
Time Frame: baseline, 8 weeks
The Connor-Davidson Resilience Scale (CD-RISC), a 25-item scale, was developed to measure resiliency. CD-RISC has been evaluated and has been found to have good internal consistency (α = .89), test-retest reliability (intraclass correlation coefficient = .87), and positive correlation with multiple related measures with ability to distinguish between participants with lesser and greater resilience. The scores can range from 0 to 100. The mean score in a general population sample was 80.7 and in psychiatric outpatients 68. A positive change with increasing scores will indicate improvement in resilience.
baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hamilton Rating Scale for Depression Score
Time Frame: baseline, 8 weeks
The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.
baseline, 8 weeks
Change in Patient Health Questionnaire-9 Score
Time Frame: baseline, 8 weeks
The Patient Health Questionnaire (PHQ) is a self-administered 9-item scale which scores each of the 9 DSM-V criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 6-10,11-15, 16-20, and >20 represented mild, moderate, moderately severe, and severe depression, respectively.
baseline, 8 weeks
Change in Quick Inventory of Depressive Symptoms Score
Time Frame: baseline, 8 weeks
The 16-item Quick Inventory of Depressive Symptomatology (QIDS) designed to assess the severity of depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The scores can range from 0 to 27, with 0 being no depression to 27 being very severe depression. Increasing scores indicate worsening depression and decreasing scores indicate improving depression.
baseline, 8 weeks
Change in Generalized Anxiety Disorder-7 Score
Time Frame: baseline, 8 weeks
Generalized Anxiety Disorder 7 (GAD-7) is a 7 item self-report scale which scores the symptoms of generalized anxiety disorder (GAD) from "0"( not at all) to "3"( nearly every day). Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety on the GAD-7.
baseline, 8 weeks
Change in Perceived Stress Scale Score
Time Frame: baseline, 8 weeks
The Perceived Stress Scale is a 10 item self-administered scale that measures the degree to which one's life are appraised as stressful. The scores can range from 0( no stress) to 40( very high stress). Scores between 0-13 are considered low stress, 14-26- moderate stress and 27-40- high stress. A decreasing trend of scores would indicate improvement in perceived stress levels.
baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashok Seshadri, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-007944

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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