The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms

Depressive Symptoms Clinical Trial

Official title:

The Effects of the "Be Mindful" Intervention in Previously Depressed College Students Currently Experiencing Subclinical Symptoms of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740879
• Other study ID #: STUDY00005212
• Secondary ID: SU-20-01
• Status: Completed
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms
• Major Depressive Disorder, Recurrent, in Remission

Intervention

Behavioral:
• Be Mindful
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).

Locations

Country	Name	City	State
United States	State University of New York at Buffalo (SUNY at Buffalo)	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	weekly during intervention, approximately 1-2 months
Primary	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).	at regular intervals until 3-month follow-up (approximately 4-5 months after the start of the study)
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months
Secondary	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).	through study completion, which can take up to 6 months