MORE vs. CBT for Smoking Cessation

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Missouri-Columbia

Must not be taking: Psychotropic medications

Disqualifiers: Untreated medical illness, Psychosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

Will I have to stop taking my current medications?

The trial requires that you have not used psychotropic medications (like those for epilepsy) in the past month, so you may need to stop taking these types of medications before participating.

What data supports the effectiveness of the treatment Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT) for smoking cessation?

Research shows that Cognitive Behavioral Therapy (CBT) is a well-established and effective treatment for quitting smoking. Mindfulness-based interventions, like Mindfulness-Oriented Recovery Enhancement (MORE), have also shown promise in helping people stop smoking, as well as in treating other addictions and improving emotional regulation. ^{1 2 3 4 5}

Is Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT) safe for humans?

Mindfulness-Based Interventions (MBIs), which include MORE and CBT, are generally considered safe for humans, but some studies suggest there may be potential adverse effects, especially in certain conditions like bipolar disorder. ^{1 4 6 7 8}

How is the treatment MORE vs. CBT for smoking cessation different from other treatments?

Mindfulness-Oriented Recovery Enhancement (MORE) is unique because it combines mindfulness training, cognitive behavioral therapy (CBT), and positive psychology to address addiction and related issues, offering a holistic approach that is different from traditional smoking cessation methods. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for adults over 18 who speak English, want to quit smoking, and have smoked for at least two years. They must be able to see well enough (with glasses if needed) to do tasks and tests. People can't join if they're pregnant, claustrophobic, use certain drugs or psychotropic meds recently, have major neurological issues or untreated illnesses, or any psychosis.

Inclusion Criteria

Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks

I am 18 years old or older.

You are willing to stop smoking.

Exclusion Criteria

Positive urine drug screen

I have a medical condition that hasn't been treated yet.

I have had a serious brain illness or head injury that made me pass out.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral interventions (MORE and CBT) to evaluate their effectiveness on smoking behavior

7 weeks

Weekly visits for assessments and therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Behavioral Therapy (CBT) (Behavioural Intervention)
• Mindfulness-Oriented Recovery Enhancement (MORE) (Behavioural Intervention)

Trial Overview The study compares the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE), which combines mindfulness with behavioral therapy to change reward processes in the brain; and Cognitive Behavioral Therapy (CBT), which helps understand how thoughts affect behavior on quitting smoking.

Participant Groups

Group I: MORE Experimental Treatment 1 Intervention

Group II: CBT Active Control 1 Intervention

Cognitive Behavioral Therapy (CBT) is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Mun Y. Choi

University of Missouri-Columbia

Chief Executive Officer since 2017

PhD in Mechanical and Aerospace Engineering from Princeton University

Richard Barohn

University of Missouri-Columbia

Chief Medical Officer since 2020

MD from the University of Missouri-Columbia School of Medicine

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

Findings from Research

Mindfulness-Oriented Recovery Enhancement (MORE) has shown moderate to small effects in reducing addictive behaviors, cravings, opioid doses, chronic pain, and psychiatric symptoms, based on a meta-analysis of 8 randomized controlled trials involving 816 participants.

The efficacy of MORE was consistent across diverse demographic groups, indicating its potential for broad application in healthcare settings to support individuals dealing with addiction and related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement for Addictive Behavior, Psychiatric Distress, and Chronic Pain: A Multilevel Meta-Analysis of Randomized Controlled Trials. Parisi, A., Roberts, RL., Hanley, AW., et al.[2022]

A study involving 113 participants found that mindfulness-based treatment (MBT) is as effective as cognitive behavioral therapy (CBT) for smoking cessation, with similar rates of quitting at 16 weeks (30.4% for MBT vs. 31.6% for CBT).

Both MBT and CBT significantly reduced the number of cigarettes smoked per day, showing no significant difference in effectiveness, making MBT a viable alternative for treating tobacco use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based treatment for smoking cessation: a randomized controlled trial. Araujo, MS., Silva, LGD., Pereira, GMA., et al.[2022]

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM) was developed and validated to assess therapist competence and adherence to the MORE treatment manual, showing high internal consistency and adequate reliability across 40 treatment sessions involving 295 participants.

Higher fidelity in delivering the MORE treatment was linked to significant reductions in opioid misuse, suggesting that the MORE-FM is an effective tool for ensuring treatment integrity and predicting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. Hanley, AW., Garland, EL.[2022]

The 8-week Mindfulness-Oriented Recovery Enhancement (MORE) intervention significantly improved emotional regulation in women undergoing treatment for opioid use disorder, as evidenced by decreased difficulty in managing emotions after the program.

Functional MRI results showed increased connectivity in brain regions associated with affect regulation after the MORE intervention, suggesting that this mindfulness approach may enhance brain function related to emotional control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. Ray, S., Bhanji, J., Kennelly, N., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) significantly reduced depression symptoms in individuals with traumatic brain injury (TBI) after an 8-week intervention, with medium to large effect sizes observed across all depression measures.

Participants also reported reduced pain intensity and increased energy levels following MBCT, highlighting its potential benefits beyond just alleviating depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. Bédard, M., Felteau, M., Marshall, S., et al.[2022]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Combining Cognitive Behavior Therapy for psychosis (CBTp) with Mindfulness-Based Interventions (MBI) significantly improved coping strategies, such as acceptance and mental disengagement, in 56 outpatients compared to CBTp alone.

The study demonstrated that MBI effectively enhances specific coping styles in individuals with psychosis, making it a feasible and beneficial addition to treatment in public healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness on Daily Life Coping in People Experiencing Psychosis: A Randomized Controlled Trial. López-Navarro, E., Al-Halabí, S.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral and Mindfulness-Based Interventions for Smoking Cessation: a Review of the Recent Literature. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement for Addictive Behavior, Psychiatric Distress, and Chronic Pain: A Multilevel Meta-Analysis of Randomized Controlled Trials. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Mindfulness-based treatment for smoking cessation: a randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Mindfulness on Daily Life Coping in People Experiencing Psychosis: A Randomized Controlled Trial. [2022]