Smoking Cessation for Depression and Anxiety Treatment

Study Overview
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Brief Summary
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The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation, and anxiety and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.

Official Title
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Integrated Smoking Cessation Treatment for Emotional Dysregulation

Conditions
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Smoking, Anxiety Disorders, Depression Disorders

Intervention / Treatment
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* Drug: Nicotine Patch
* Behavioral: Depression and Anxiety Smoking Cessation Treatment
* Behavioral: Educational-Support Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-65 years old Capable of providing informed consent Willing to attend all study visits and comply with the protocol Daily smoker for at least one year Currently smoke an average of at least 6 cigarettes per day Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale Elevated anxiety or depression Exclusion Criteria: Use of other tobacco products Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol Currently suicidal or high suicide risk Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression Current or intended participation in a concurrent substance abuse treatment Current non-nicotine substance dependence Insufficient command of English to participate in assessment or treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depression and Anxiety Smoking Cessation Treatment<br>Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies | Drug: Nicotine Patch<br> <br> Behavioral: Depression and Anxiety Smoking Cessation Treatment<br>* Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies<br>* Other names: SDAT;|
| Active Comparator: Educational-Support Psychotherapy<br>Educational-based psychotherapy and standard smoking cessation treatment program | Drug: Nicotine Patch<br> <br> Behavioral: Educational-Support Psychotherapy<br>* Educational-based psychotherapy and standard smoking cessation treatment program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status using the Timeline Follow-Back Assessment | Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking). | Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, cessation, anxiety, anxious, depression, depressed, smoker, stress