Major DepressionNCT04388748
Stress Management and Resiliency Training for Depression vs Treatment as Usual in the Treatment of Major Depression
A study testing Stress Management and Resiliency Training for Depression (SMART-D) Therapy in people with Major Depression, run by Mayo Clinic at 3 sites in United States.
Trial summary
Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Stress Management and Resiliency Training for Depression (SMART-D) Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Dec 2020to 25 May 2023
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin, MN, with a diagnosis of major depression, in partial or near remission with PHQ-9 scores ≤14
- Participants will be required to be between 25 and 80 years old
- Able to speak English
- Able to provide written informed consent to participate in the study
- Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013).
- Participants will continue taking any prescribed medications from their clinical treatment team.
- Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
- Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.
Who cannot join
- Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
- Pregnant women - because of time duration of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Mayo Clinic Health System in Austin
Austin, Minnesota, 55912
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression
Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.
- Conditions
- Major Depression
- Being tested
- Stress Management and Resiliency Training for Depression (SMART-D) Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Resiliency Training for Depression (SMART-D) TherapyBehavioural
6 SMART-D group therapy sessions over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| SMART-D Intervention Group | Experimental | Subjects will participate in Stress Management and Resiliency Training for Depression (SMART-D) therapy as well as treatment as usual which consists of any ongoing medication or psychotherapy based treatments that are currently in place. Receives: Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) Therapy |
| Standard of Care Group | No intervention | Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient health questionnaire depression assessment
Measured using the patient health questionnaire (PHQ-9) where total scores are reported on a scale of 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression
Measured: Baseline, week 1, week 8, 3 months, 6 months
Change in severity of depression
Measured using the 17 item Hamilton Depression Rating scale (HAM-D) where total scores are reported on a scale of 0 - 7 = Normal, 8 - 13 = Mild Depression, 14-18 = Moderate Depression, 19 - 22 = Severe Depression, > 23 = Very Severe Depression
Measured: Baseline, week 1, week 8, 3 months, 6 months
Secondary outcomes (2)
Change in measures of resilience
Measured using the Connor Davidson Resiliency Scale. Subjects are asked to indicate if they agree with 25 statements on a scale of 0=not true at all, 1=rarely true, 2=sometimes true, 3=often true and 4=true nearly all the time
Measured: 1 week, 8 week, 3 month, 6 month
Changed in perceived stress scale
Measured using Perceived Stress Scale (PSS). Subjects are asked to answer a 10 question about their feelings and thoughts during the last month using a scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often
Measured: 1 week, 8 week, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start18 Dec 2020
- Primary completion24 Oct 2022
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashok Seshadri, Mayo Clinic
- Investigators
- Ashok Seshadri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388748
- Sponsor's protocol ID
- 19-009475
- Status last verified
- Jun 2023
- First submitted
- 12 May 2020
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seshadri A, Fuller-Tyszkiewicz M, Harper L, Clark MM, Singh B, Chesak S, Kaur AS, McGillivray J, Frye MA. Randomized controlled trial of stress management and resiliency training for depression (SMART-D)-pilot study. PLoS One. 2025 Aug 19;20(8):e0328539. doi: 10.1371/journal.pone.0328539. eCollection 2025.
PubMed 40828809
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT04388748
- Acronym / sponsor ID
- 19-009475
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 14 May 2020 (actual)
- 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.
Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART-D Intervention Group | Experimental | Behavioral: Stress Management and Resiliency Training for Depression (SMART-D) TherapySubjects will participate in Stress Management and Resiliency Training for Depression (SMART-D) therapy as well as treatment as usual which consists of any ongoing medication or psychotherapy based treatments that are currently in place. |
| Standard of Care Group | No intervention | –Treatment as usual will consist of any ongoing medication or psychotherapy based treatments that are currently in place. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin, MN, with a diagnosis of major depression, in partial or near remission with PHQ-9 scores ≤14
- Participants will be required to be between 25 and 80 years old
- Able to speak English
- Able to provide written informed consent to participate in the study
- Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013).
Key exclusion criteria (2 listed)
- Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
- Pregnant women - because of time duration of the study.
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 |
|---|---|---|
| Stress Management and Resiliency Training for Depression (SMART-D) Therapy6 SMART-D group therapy sessions over 8 weeks | Behavioural | SMART-D Intervention Group |
Primary outcome
Change in patient health questionnaire depression assessment
Time frame: Baseline, week 1, week 8, 3 months, 6 months
Measured using the patient health questionnaire (PHQ-9) where total scores are reported on a scale of 1-4 Minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression
Change in severity of depression
Time frame: Baseline, week 1, week 8, 3 months, 6 months
Measured using the 17 item Hamilton Depression Rating scale (HAM-D) where total scores are reported on a scale of 0 - 7 = Normal, 8 - 13 = Mild Depression, 14-18 = Moderate Depression, 19 - 22 = Severe Depression, > 23 = Very Severe Depression
2 secondary outcomes
Change in measures of resilience
Time frame: 1 week, 8 week, 3 month, 6 month
Changed in perceived stress scale
Time frame: 1 week, 8 week, 3 month, 6 month
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 23 Jun 2023.
- Derived from this study: PubMed 40828809Seshadri A, Fuller-Tyszkiewicz M, Harper L, Clark MM, Singh B, Chesak S, Kaur AS, McGillivray J, Frye MA. Randomized controlled trial of stress management and resiliency training for depression (SMART-D)-pilot study. PLoS One. 2025 Aug 19;20(8):e0328539. doi: 10.1371/journal.pone.0328539. eCollection 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ashok Seshadri, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and Resiliency Training for Depression (SMART-D) Therapy in people with Major Depression, run by Mayo Clinic at 3 sites 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 8 inclusion and 2 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 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in patient health questionnaire depression assessment (time frame: Baseline, week 1, week 8, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04388748, which also lists 1 linked publication.
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 23 Jun 2023.