Acceptance and Commitment Therapy for Tobacco Cessation Among Psychiatric Partial Hospital Patients

NCT03911960 | Completed Results

• 1 other identifier: 1R03DA043596-01A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

People with serious mental illness are three times more likely to smoke cigarettes than people without mental illness. People with mental illness are less likely to be successful in quitting smoking than those without mental illness. Therefore, the healthcare community needs to find ways to get people with mental illness treatment to help them stop smoking. This study explores whether a treatment, called acceptance and commitment therapy, which is an affective therapy for serious mental illness, can help patients with serious mental illness stop smoking. In particular, the investigators test whether patients will be interested in receiving acceptance and commitment therapy for smoking cessation in a psychiatric partial hospital (also known as a day treatment program), whether they are able to complete the treatment, and whether it will help them stop smoking compared to usual care. To test these research questions, 40 patients in the Rhode Island Hospital's psychiatric partial hospital will be recruited. Half of the patients will receive acceptance and commitment therapy to help them stop smoking (2 in person sessions, 5 telephone sessions) and half will receive usual care (2 in person sessions, electronic referral to the Rhode Island tobacco quit line). All participants will be offered the nicotine patch. All participants will complete a baseline survey and a follow-up visit at the end of treatment to measure whether they stopped smoking and whether they liked the treatment. The study will also measure how many participants completed the treatment sessions. If successful, this treatment model could be a way to get more patients with mental illness into treatment.

Conditions

Tobacco Smoking; Psychiatric Disorder; Psychiatric Hospitalization

Keywords

tobacco smoking; psychiatric disorder; psychiatric hospitalization; acceptance and commitment therapy

Outcome Measures

Primary Outcomes (4)

• Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study

  proportion of smokers seen during the partial hospital visit who enroll in the study

  Through study completion, approximately 5 months.

• Percentage of Counseling Sessions Completed

  number of scheduled counseling sessions completed

  through study completion, an average of 7 weeks.

• Client Satisfaction Questionnaire

  The Client satisfaction Questionnaire, measures acceptability of the intervention to patients, minimum value=8, maximum value=32, higher scores indicate higher satisfaction (higher scores mean better outcome)

  at study completion, an average of 7 weeks post-enrollment

• Number of Participants Who Are Rehospitalized for Psychiatric Reasons

  This is a simple count based on follow-up survey data of the number of participants who reported being hospitalized for a psychiatric reason following enrollment in the study.

  At study completion, an average of 7 weeks post enrollment

Secondary Outcomes (2)

• Number of Participants Who Are Abstinent From Tobacco

  at study completion, an average of 7 weeks post enrollment

• Kessler 6

  Change between baseline and study completion, 7 weeks post-enrollment

Other Outcomes (2)

• Avoidance Inflexibility Scale

  Change between baseline and study completion, 7 weeks post-enrollment

• Commitment to Quitting Scale

  Change between baseline and study completion, 7 weeks post-enrollment

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.

Behavioral: Acceptance and Commitment Therapy

Enhanced Usual Care

ACTIVE COMPARATOR

2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch

Behavioral: Enhanced Usual Care

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch

Acceptance and Commitment Therapy

Enhanced Usual Care BEHAVIORAL

2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be male and female
• psychiatry partial hospital patients
• current daily smokers
• ≥ age 18
• have regular telephone access
• able to read and write English

You may not qualify if:

• current use of tobacco cessation treatment (bupropion prescribed for a psychiatric indication will be permitted)

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Mental Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Sandra Japuntich
• Organization: Hennepin Healthcare

sandra.japuntich@hcmed.org

6128736856

Study Officials

• Sandra Japuntich, Ph.D.

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

• Ernestine Jennings, Ph.D.

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 11, 2019
• Study Start: April 16, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: within 18 months of study completion
• Access Criteria: ethical guidelines for The Miriam Hospital will be followed (the investigator will have completed a research ethics training course and the data will be stored securely)

Locations

US (1)