Smoking Cessation for Depression and Anxiety Treatment

Phase 1

Completed

• Conditions: Smoking; Anxiety Disorders; Depression Disorders
• Interventions: Drug: Nicotine Patch; Behavioral: Depression and Anxiety Smoking Cessation Treatment; Behavioral: Educational-Support Psychotherapy

• Registration Number: NCT02002858
• Lead Sponsor: University of Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Study Start: 2014-10
• Primary Completion: 2016-11
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depression and Anxiety Smoking Cessation Treatment	Depression and Anxiety Smoking Cessation Treatment	Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Educational-Support Psychotherapy	Educational-Support Psychotherapy	Educational-based psychotherapy and standard smoking cessation treatment program
Educational-Support Psychotherapy	Nicotine Patch	Educational-based psychotherapy and standard smoking cessation treatment program
Depression and Anxiety Smoking Cessation Treatment	Nicotine Patch	Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Primary Outcome Measures

Name	Time	Method
Smoking Status using the Timeline Follow-Back Assessment	Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.	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).

Trial Locations

Locations (1)

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic; 🇺🇸 Houston, Texas, United States