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Smoking Cessation for Depression and Anxiety Treatment (SDAT)

Primary Purpose

Smoking, Anxiety Disorders, Depression Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine Patch
Depression and Anxiety Smoking Cessation Treatment
Educational-Support Psychotherapy
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring smoking, cessation, anxiety, anxious, depression, depressed, smoker, stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Anxiety and Health Research Laboratory and Substance Use Treatment Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Depression and Anxiety Smoking Cessation Treatment

Educational-Support Psychotherapy

Arm Description

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

Educational-based psychotherapy and standard smoking cessation treatment program

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 25, 2013
Last Updated
July 6, 2017
Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02002858
Brief Title
Smoking Cessation for Depression and Anxiety Treatment
Acronym
SDAT
Official Title
Integrated Smoking Cessation Treatment for Emotional Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Anxiety Disorders, Depression Disorders
Keywords
smoking, cessation, anxiety, anxious, depression, depressed, smoker, stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depression and Anxiety Smoking Cessation Treatment
Arm Type
Experimental
Arm Description
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Arm Title
Educational-Support Psychotherapy
Arm Type
Active Comparator
Arm Description
Educational-based psychotherapy and standard smoking cessation treatment program
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Intervention Type
Behavioral
Intervention Name(s)
Depression and Anxiety Smoking Cessation Treatment
Other Intervention Name(s)
SDAT
Intervention Description
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Intervention Type
Behavioral
Intervention Name(s)
Educational-Support Psychotherapy
Intervention Description
Educational-based psychotherapy and standard smoking cessation treatment program
Primary Outcome Measure Information:
Title
Smoking Status using the Timeline Follow-Back Assessment
Description
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).
Time Frame
Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77201
Country
United States

12. IPD Sharing Statement

Links:
URL
http://uh.edu/ahrl-sutc
Description
Project Website

Learn more about this trial

Smoking Cessation for Depression and Anxiety Treatment

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