Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Standard Treatment (ST) (active comparator) and Behavioral Activation for Smoking (experimental).

Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.

The registry classes the interventions as behavioral and drug.

More on the Plan

The researchers will recruit 200 smokers with elevated depressive symptoms who will be randomized into one of two treatment groups.

Treatment will be delivered in group format across both the BATS (n = 100) and ST condition (n = 100).

All participants will receive 8 weeks of transdermal nicotine patch in addition to their assigned treatment group.

The researchers intend to compare the BA treatment for smoking (BATS) to a standard smoking cessation intervention (ST)on abstinence and relapse outcomes.

Who Took Part

Enrollment: 184 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Between 18 and 65 years of age. A regular smoker for at least one year. Currently smoking an average of at least 10 cigarettes per day. Want to quit smoking. Report current elevated depressive symptoms.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: current axis i disorder; psychoactive substance dependence (excluding nicotine dependence) within the past 6 months; current use of psychotropic medication or participation in any form of psychotherapy.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2010-09 with completion listed for 2016-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date (time frame: 52 weeks post quit date).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 184 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.