Depressive SymptomsNCT04740879
The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms
A study testing Be Mindful in people with Depressive Symptoms and Major Depressive Disorder, Recurrent, in Remission, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms, Major Depressive Disorder, Recurrent, in Remission
- What is being tested?
- Be Mindful
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 1 Aug 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
- meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)
Who cannot join
- responses suggest they have never experienced a Major Depressive Episode
- responses suggest they are not currently experiencing sub-threshold symptoms of depression
- they state they are not open to learning mindfulness or meditation techniques
- they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
- they indicate their age is not between 18 and 65
- they state they do not currently live in New York State
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo (SUNY at Buffalo)
Buffalo, New York, 14260
About this study
Official title: The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression
This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).
Read the detailed description
Participant outcome variables will be assessed weekly for the first month after baseline. This will include the primary dependent variable (i.e., depressive symptoms), but will also include variables that will be explored as potential mechanisms of change (i.e., mindfulness, decentering, rumination, worry, self-compassion, and dysfunctional attitudes). The final weekly assessment will represent the Post-Intervention assessment.
Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire. There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable.
After the 3-month follow-up, the Waitlist Control condition will be given access to the intervention. All participants (i.e., in both conditions) will be asked to complete another month of weekly questionnaires. These questionnaires will be identical to the first set of weekly questionnaires, and will allow mechanisms of change to be evaluated in the Waitlist Control condition.
- Being tested
- Be Mindful
- Keywords
- Mindfulness Based Cognitive Therapy, Be Mindful Intervention, Past Major Depressive Disorder, Major Depressive Disorder, Depressive Symptoms, Mechanisms of Change
- Medical subject headings
- Depression, Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be MindfulBehavioural
The online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses. Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors. Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos. The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Intervention condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" immediately after randomization to group. Receives: Behavioral: Be Mindful |
| Waitlist Control | Other | The Waitlist Control condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" approximately 4 months after randomization to group. Receives: Behavioral: Be Mindful |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Measured: weekly during intervention, approximately 1-2 months
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Measured: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Secondary outcomes (8)
Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
Participants are asked to rate items on a scale of 1 (never or rarely true) to 5 (very often or always true).
Measured: through study completion, which can take up to 6 months
Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
Participants are asked to rate items on a scale of 0 (not at all) to 4 (very much).
Measured: through study completion, which can take up to 6 months
Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
Measured: through study completion, which can take up to 6 months
Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
Participants are asked to rate items on a scale of 1 (Not at all typical of me) to 5 (Very typical of me).
Measured: through study completion, which can take up to 6 months
Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
Participants are asked to rate items on a scale of 1 (Almost never) to 4 (Almost always).
Measured: through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
Participants are asked to rate items on a scale of 1 (totally agree) to 4 (totally disagree).
Measured: through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
Participants are asked to rate items on a scale of 0 (strongly disagree) to 3 (strongly agree).
Measured: through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
Participants are asked to rate items on a scale of 1 (Not Very True of Me) to 5 (Very True of Me).
Measured: through study completion, which can take up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start30 Mar 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Bauer, State University of New York at Buffalo
- Investigators
- Meghan E Bauer, MA, Principal investigator, State University of New York at BuffaloJohn E Roberts, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740879
- Sponsor's protocol ID
- STUDY00005212
- Other IDs
- SU-20-01
- Status last verified
- May 2023
- First submitted
- 1 Feb 2021
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression
- ClinicalTrials.gov ID
- NCT04740879
- Acronym / sponsor ID
- STUDY00005212
- Keywords
- Mindfulness Based Cognitive Therapy, Be Mindful Intervention, Past Major Depressive Disorder, Major Depressive Disorder, Depressive Symptoms, Mechanisms of Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 5 Feb 2021 (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.
This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).
Detailed description
Participant outcome variables will be assessed weekly for the first month after baseline. This will include the primary dependent variable (i.e., depressive symptoms), but will also include variables that will be explored as potential mechanisms of change (i.e., mindfulness, decentering, rumination, worry, self-compassion, and dysfunctional attitudes). The final weekly assessment will represent the Post-Intervention assessment.
Brief follow-up assessments of the primary dependent variable will be given 1-month and 2-months after the final weekly questionnaire. There will be a 3-month assessment that measures potential mechanisms of change in addition to the primary dependent variable.
After the 3-month follow-up, the Waitlist Control condition will be given access to the intervention. All participants (i.e., in both conditions) will be asked to complete another month of weekly questionnaires. These questionnaires will be identical to the first set of weekly questionnaires, and will allow mechanisms of change to be evaluated in the Waitlist Control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Be MindfulThe Intervention condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" immediately after randomization to group. |
| Waitlist Control | Other | Behavioral: Be MindfulThe Waitlist Control condition will be provided with access to the 4-week online Mindfulness-Based Cognitive Therapy course "Be Mindful" approximately 4 months after randomization to group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- currently experiencing mild to moderate depressive symptoms (Patient Health Questionnaire 9 Current scores between 5 and 14)
- meet Diagnostic and Statistical Manual of Mental Disorders (fifth edition; DSM-5) criteria for Past Major Depressive Disorder (determined by clinical interview)
Key exclusion criteria (6 listed)
- responses suggest they have never experienced a Major Depressive Episode
- responses suggest they are not currently experiencing sub-threshold symptoms of depression
- they state they are not open to learning mindfulness or meditation techniques
- they indicate they are currently receiving therapeutic treatment for depression or stress management elsewhere
- they indicate their age is not between 18 and 65
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 |
|---|---|---|
| Be MindfulThe online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses. Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors. Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos. The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com). | Behavioural | Intervention, Waitlist Control |
Primary outcome
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention
Time frame: weekly during intervention, approximately 1-2 months
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 at 3-Month Follow-Up
Time frame: at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Participants are asked to rate items on a scale of 0 (Not at all) to 3 (Nearly every day).
8 secondary outcomes
Mean Change in Mindfulness from Baseline as Measured by the Five Factor Mindfulness Questionnaire Short Form
Time frame: through study completion, which can take up to 6 months
Mean Change in Decentering from Baseline as Measured by the Toronto Mindfulness Scale
Time frame: through study completion, which can take up to 6 months
Mean Change in Rumination from Baseline as Measured by the Ruminative Response Questionnaire
Time frame: through study completion, which can take up to 6 months
Mean Change in Worry from Baseline as Measured by the Penn State Worry Questionnaire
Time frame: through study completion, which can take up to 6 months
Mean Change in Self-Compassion from Baseline as Measured by the Self-Compassion Scale Short Form
Time frame: through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Dysfunctional Attitudes Scale (Short Form 1)
Time frame: through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Rosenberg Self-Esteem Scale
Time frame: through study completion, which can take up to 6 months
Mean Change in Dysfunctional Attitudes from Baseline as Measured by the Single-Item Self-Esteem Scale
Time frame: through study completion, which can take up to 6 months
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 18 May 2023.
Related trials for Depressive Symptoms
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Meghan E Bauer, MA principal investigator
State University of New York at Buffalo
John E Roberts, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be Mindful in people with Depressive Symptoms and Major Depressive Disorder, Recurrent, in Remission, run by State University of New York at Buffalo 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 2 inclusion and 6 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 18 May 2023. 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?
Mean Change in Depressive Symptoms from Baseline as Measured by the Patient Health Questionnaire 9 Post-Intervention (time frame: weekly during intervention, approximately 1-2 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?
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 18 May 2023.