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Smoking Cessation for Depression and Anxiety Treatment

Integrated Smoking Cessation Treatment for Emotional Dysregulation

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02002858
Acronym
SDAT
Enrollment
12
Registered
2013-12-06
Start date
2014-10-31
Completion date
2017-05-31
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depression Disorders, Smoking

Keywords

smoking, cessation, anxiety, anxious, depression, depressed, smoker, stress

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.

Interventions

DRUGNicotine Patch
BEHAVIORALDepression and Anxiety Smoking Cessation Treatment

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

BEHAVIORALEducational-Support Psychotherapy

Educational-based psychotherapy and standard smoking cessation treatment program

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking Status using the Timeline Follow-Back AssessmentChange 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026