Development of Positive Psychotherapy for Smoking Cessation

NCT01451814 | Completed Phase 2 Results

• 1 other identifier: NCI-156241-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.

Conditions

Smoking

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (3)

• 7-day Point Prevalence Smoking Abstinence at 8 Weeks

  Biochemically verified abstinence from smoking over the past 7 days

  8 weeks

• 7-day Point Prevalence Smoking Abstinence at 16 Weeks

  Biochemically verified abstinence from smoking over the past 7 days

  16 Weeks

• 7-day Point Prevalence Smoking Abstinence at 26 Weeks

  Biochemically verified abstinence from smoking over the past 7 days

  26 Weeks

Study Arms (2)

Positive psychotherapy

EXPERIMENTAL

6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.

Behavioral: Positive Psychotherapy for smoking cessation; Drug: Nicotine polacrilex; Behavioral: Behavioral smoking cessation treatment

Standard treatment

ACTIVE COMPARATOR

6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition

Drug: Nicotine polacrilex; Behavioral: Relaxation training; Behavioral: Behavioral smoking cessation treatment

Interventions

Positive Psychotherapy for smoking cessation BEHAVIORAL

6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.

Positive psychotherapy

Nicotine polacrilex DRUG

8 weeks of nicotine patch

Positive psychotherapy; Standard treatment

Relaxation training BEHAVIORAL

Instructions in progressive muscle relaxation

Standard treatment

Behavioral smoking cessation treatment BEHAVIORAL

Counseling on techniques to manage triggers and avoid smoking

Positive psychotherapy; Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use
• willing to use the transdermal nicotine patch
• report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.

You may not qualify if:

• are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence)
• taking prescribed psychotropic medication or receiving other forms of psychotherapy
• concomitantly using other pharmacotherapies for smoking cessation
• have any contraindications for use of the transdermal nicotine patch.

Sponsors & Collaborators

• Brown University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Alcohol and Addiction Studies, Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• Kahler CW, Spillane NS, Day AM, Cioe PA, Parks A, Leventhal AM, Brown RA. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2015 Nov;17(11):1385-92. doi: 10.1093/ntr/ntv011. Epub 2015 Feb 2.

  PMID: 25646352 RESULT

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Relaxation Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Christopher Kahler
• Organization: Brown University School of Public Health

Christopher_Kahler@brown.edu

401 863-6651

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Behavioral and Social Sciences

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 18, 2015
• Results First Posted: March 18, 2015

Record last verified: 2015-03

Locations

US (1)