MORE vs. CBT for Smoking Cessation

Recruiting at 1 trial location

Overseen By Madhura Athreya, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Psychotropic medications

Disqualifiers: Untreated medical illness, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two types of therapy can help people quit smoking. One method, Mindfulness-Oriented Recovery Enhancement (MORE), uses mindfulness to alter reactions to cravings. The other, Cognitive Behavioral Therapy (CBT), helps individuals understand how thoughts and feelings influence smoking habits. The trial seeks current smokers who have smoked for at least 2 years and are interested in quitting. As an unphased trial, participants can contribute to innovative research that may provide new insights into effective smoking cessation strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) is a therapy that most people handle well. It helps with stress, pain, and addictive behaviors. Although specific information about its effects on quitting smoking is limited, positive feedback suggests it's safe for most individuals.

For Cognitive Behavioral Therapy (CBT), studies have demonstrated its effectiveness in helping people stop smoking. In one study, 90% of participants completed the program and rated it highly, indicating that CBT is generally safe and well-liked by those trying to quit smoking.

Overall, both therapies appear safe and are well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness-Oriented Recovery Enhancement (MORE) because it offers a fresh approach to smoking cessation, different from standard options like nicotine replacement therapy and medications such as varenicline. MORE integrates mindfulness practices, which help individuals manage cravings and stress by enhancing awareness and emotional regulation. This technique aims to fundamentally change how smokers react to cues that typically trigger smoking, potentially leading to more sustainable long-term results. Meanwhile, Cognitive Behavioral Therapy (CBT) is known for its structured approach to changing thought patterns related to smoking. Together, these methods provide innovative ways to tackle smoking addiction beyond traditional pharmacological treatments.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

This trial will compare Mindfulness-Oriented Recovery Enhancement (MORE) with Cognitive Behavioral Therapy (CBT) for smoking cessation. Research shows that MORE is a promising method to help people quit smoking. It combines mindfulness exercises with techniques to change how the brain responds to rewards, which can help reduce cravings and support quitting. Studies have found that MORE effectively addresses both the mental and emotional sides of addiction, aiding in smoking cessation.

For participants in the CBT arm, research has shown it significantly improves the chances of quitting smoking. Specifically, people who receive CBT are up to four times more likely to quit than those without this support. CBT helps individuals understand and change the thoughts and feelings that lead to smoking, making it a strong option for those wanting to quit. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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

You are willing to stop smoking.

English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

Group I: MORE Experimental Treatment 1 Intervention

Group II: CBT Active Control 1 Intervention

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

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

Approved in European Union as Cognitive Behavioural Therapy for:

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

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+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

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]

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]

Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Interventions (MBIs) are both effective methods for helping people quit smoking, including special populations like low-income individuals and pregnant women.

Recent studies suggest that both CBT and MBIs can be successfully delivered through mobile and online platforms, indicating their potential for widespread use, but further research is needed to identify which method works best for different groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12245522/

Effect of cognitive behavior therapy on abstinence among ... The pooled analysis revealed that CBT significantly improved smoking abstinence rates, demonstrating a fourfold increase in effectiveness ...

2. academic.oup.com academic.oup.com/ntr/article/24/11/1763/6574261

Long-Term Effectiveness of a Clinician-Assisted Digital ... This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable ...

3. formative.jmir.org formative.jmir.org/2024/1/e48050/PDF

Preliminary Efficacy of a Cognitive Behavioral Therapy– ... The success rate of quitting smoking after 1 year was 3%-5% for those without support, 7%-16% when smokers received behavioral intervention, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7874528/

Cognitive Behavioral and Mindfulness-Based Interventions ... CBT participants also reported greater motivation to quit smoking and a greater willingness to continue using the app. These preliminary findings indicate that ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.759896/full

Feasibility and Acceptability of a Cognitive Behavioral ... Participants who believed/agreed this app can help them to quit smoking significantly increased from 69% at baseline to 97% at day 33 after quit ...

6. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4119230/

Extended cognitive behavior therapy for cigarette smoking ... Results. At week 20 follow-up, CBT produced a higher 7-day point prevalence abstinence rate: 45% versus 29%, P = 0.006 ...

8. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-025-00559-w

Initial assessment of a novel smoking cessation program ... Self-reported 7-day smoking abstinence data were available for 88.7% (63/71) of participants at 12 weeks post-baseline, and for 76.1% (54/71) of ...