Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03382093
Other study ID # CR00000267
Secondary ID 5F31DA043390-02
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2017
Est. completion date June 1, 2019

Study information

Verified date June 2019
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.


Description:

The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Elevated anxiety sensitivity defined as an ASI-III score of at least 17

- Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 4 ppm)

- Not presently engaged in a quit attempt

- Not currently engaged in mental health treatment

- Capable of providing informed consent

- Willing to attend all study visits and comply with the protocol

Exclusion Criteria:

- Adults unable to consent

- Individuals who are not yet adults (infants, children, teenagers)

- Pregnant women

- Prisoners

- Students for whom you have direct access to/influence on grades

- Use of other tobacco products

- Currently suicidal or high suicide risk

- Currently psychotic or high psychotic risk

- Insufficient command of English to participate in assessment or treatment

Study Design


Intervention

Behavioral:
Personalized Feedback Intervention
Personalized Feedback Intervention for smoking and anxiety.
Smoking Information Control
Smoking Information with no personalized feedback.

Locations

Country Name City State
United States Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Houston National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate PFI Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey. Assessed at 1-month follow-up after the one-session intervention
Secondary Smoking Motivational Processes Smokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure. Assessed at 1-month follow-up after the one-session intervention
Secondary Smoking Behavior Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis. Assessed at 1-month follow-up after the one-session intervention
Secondary Affective Processes Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure. Assessed at 1-month follow-up after the one-session intervention
Secondary Mechanisms Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire. Assessed at 1-month follow-up after the one-session intervention
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A

External Links