SDAT: Smoking Cessation for Depression and Anxiety Treatment

Sponsor

University of Houston (Other)

Overall Status

Completed

CT.gov ID

NCT02002858

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Anxiety Disorders Depression Disorders	Drug: Nicotine Patch Behavioral: Depression and Anxiety Smoking Cessation Treatment Behavioral: Educational-Support Psychotherapy	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Integrated Smoking Cessation Treatment for Emotional Dysregulation

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Depression and Anxiety Smoking Cessation Treatment

Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Drug: Nicotine Patch

Behavioral: Depression and Anxiety Smoking Cessation Treatment

Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Other Names:

SDAT

Active Comparator: Educational-Support Psychotherapy

Educational-based psychotherapy and standard smoking cessation treatment program

Drug: Nicotine Patch

Behavioral: Educational-Support Psychotherapy

Educational-based psychotherapy and standard smoking cessation treatment program

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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