NCT02002858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

November 25, 2013

Last Update Submit

July 6, 2017

Conditions

SmokingAnxiety DisordersDepression Disorders

Keywords

smokingcessationanxietyanxiousdepressiondepressedsmokerstress

Outcome Measures

Primary Outcomes (1)

  • 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).

    Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.

Study Arms (2)

Depression and Anxiety Smoking Cessation Treatment

EXPERIMENTAL

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

Drug: Nicotine PatchBehavioral: Depression and Anxiety Smoking Cessation Treatment

Educational-Support Psychotherapy

ACTIVE COMPARATOR

Educational-based psychotherapy and standard smoking cessation treatment program

Drug: Nicotine PatchBehavioral: Educational-Support Psychotherapy

Interventions

Nicotine PatchDRUG
Depression and Anxiety Smoking Cessation TreatmentEducational-Support Psychotherapy
Depression and Anxiety Smoking Cessation TreatmentBEHAVIORAL

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

Also known as: SDAT
Depression and Anxiety Smoking Cessation Treatment
Educational-Support PsychotherapyBEHAVIORAL

Educational-based psychotherapy and standard smoking cessation treatment program

Educational-Support Psychotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic

Houston, Texas, 77201, United States

Location

MeSH Terms

Conditions

SmokingAnxiety DisordersDepressionConsciousness Disorders

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

BehaviorMental DisordersBehavioral SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Michael J Zvolensky, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 6, 2013

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

US(1)