Smoking Cessation for Depression and Anxiety Treatment (SDAT)

University of Houston

Status and phase: Completed; Phase 1

Conditions: Depression Disorders; Anxiety Disorders; Smoking

Treatments: Behavioral: Educational-Support Psychotherapy; Drug: Nicotine Patch; Behavioral: Depression and Anxiety Smoking Cessation Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02002858

R34DA034741 (U.S. NIH Grant/Contract)

1R34DA03474101

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Depression and Anxiety Smoking Cessation Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Depression and Anxiety Smoking Cessation Treatment

Drug: Nicotine Patch

Educational-Support Psychotherapy

Active Comparator group

Description:

Educational-based psychotherapy and standard smoking cessation treatment program

Treatment:

Behavioral: Educational-Support Psychotherapy

Drug: Nicotine Patch