What side effects are associated with this type of intervention?

Mindfulness-Based Cognitive Therapy (MBCT) is generally well-tolerated with minimal side effects, but some individuals may experience increased anxiety or emotional discomfort as they become more aware of their thoughts and feelings. Traditional Cognitive-Behavioral Therapy (CBT) also has few side effects, though it can sometimes lead to temporary increases in distress as patients confront challenging thoughts and behaviors. In contrast, pharmacotherapy for depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), can have side effects including nausea, insomnia, sexual dysfunction, and weight gain.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like duloxetine and venlafaxine. These medications work by altering neurotransmitter levels in the brain to improve mood and alleviate depressive symptoms. In contrast, Mindfulness-Based Cognitive Therapy (MBCT) is a non-pharmacological approach that increases awareness and acceptance of thoughts and feelings through mindfulness practices and cognitive therapy techniques. While pharmacotherapy focuses on biochemical changes, MBCT aims to change the patient's relationship with their thoughts and emotions, offering an alternative or complementary treatment for depression.

What other types of research exist?

Promising, novel alternatives to Mindfulness-Based Cognitive Therapy for depression patients in 2024 include: 1) Integrative Cognitive-Affective Therapy (ICAT), which combines cognitive and affective techniques to address emotional regulation and cognitive distortions. 2) Emotion-Focused Therapy (EFT), which emphasizes processing and transforming emotional experiences. 3) Pharmacotherapy advancements such as the use of Lisdexamfetamine, which has shown efficacy in treating mood disorders. 4) Neurofeedback and biofeedback therapies, which use real-time monitoring to help patients gain control over certain physiological functions. 5) Digital and telehealth-based Cognitive Behavioral Therapy (CBT) programs, which offer greater accessibility and flexibility for patients.

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Behavioral Intervention

Mindfulness Therapy for Migraines (TEAM-M Trial)

N/A

Recruiting

Led By Elizabeth K Seng, Ph.D.

Research Sponsored by Amanda Shallcross

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 0 to month 3

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a type of therapy called Mindfulness-Based Cognitive Therapy, provided over the phone, through video calls, or as part of regular care with added support. It aims to help people with migraines and depressive symptoms by teaching them to focus on the present moment and understand their thought patterns better. Mindfulness-Based Cognitive Therapy (MBCT) was developed to prevent relapse in recurrent depression by combining cognitive behavioral therapy and meditative techniques.

Who is the study for?

This trial is for adults over 18 who have migraines 4-14 days a month and mild to moderate depression. They must meet specific migraine criteria, be able to read/speak English, consent to participate, and keep a headache diary. Excluded are those with certain psychiatric conditions, recent changes in migraine or antidepressant medications, prior mindfulness therapy experience, daily meditation practice, or unstable medication use.

What is being tested?

The study tests Mindfulness-Based Cognitive Therapy (MBCT) for treating migraines and mood issues. It's delivered in three ways: by phone calls (Telephone), video sessions (Video), or through online education modules (Online). Participants will be randomly assigned to one of these methods.

What are the potential side effects?

Since the interventions involve non-invasive therapies like telephone calls, video sessions, and online modules focused on mindfulness and cognitive therapy techniques rather than drugs or medical procedures; significant side effects are not expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 0 to month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 0 to month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 0 to month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Client Satisfaction Questionnaire - 8 (CSQ-8)

Percentage of Treatment Session Adherence

Secondary study objectives

Change in Headache Disability Inventory (HDI)

Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)

Mental Depression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: MBCT-TelephoneActive Control1 Intervention

8 weekly classes delivered via telephone.

Group II: Enhanced Usual Care (EUC)Active Control1 Intervention

8 weekly online modules delivered via web portal.

Group III: MBCT-VideoActive Control1 Intervention

8 weekly classes delivered via video.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness-Based Cognitive Therapy (MBCT) works by increasing patients' awareness and acceptance of their thoughts and feelings through mindfulness practices and cognitive therapy techniques. This approach helps patients to break the cycle of depressive relapse by teaching them to observe their thoughts non-judgmentally and to develop a different relationship with their negative thoughts and emotions. This matters for depression patients as it empowers them with skills to manage their symptoms and reduce the likelihood of future depressive episodes. Other common treatments for depression include pharmacotherapy, which typically involves antidepressants that alter neurotransmitter levels in the brain to improve mood, and various forms of psychotherapy such as Cognitive Behavioral Therapy (CBT), which focuses on changing negative thought patterns and behaviors. These treatments are crucial as they offer different mechanisms to address the complex nature of depression, providing patients with multiple options to find the most effective approach for their individual needs.