NCT03911960

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

Completed NA Results posted Last updated 25 September 2020

What this trial tests

NA trial testing Acceptance and Commitment Therapy in Tobacco Smoking in 17 participants. Completed in 15 November 2019.

Timeline

16 April 2019

Primary endpoint
15 November 2019

15 November 2019

Quick facts

Lead sponsor	The Miriam Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	16 April 2019
Primary completion	15 November 2019
Estimated completion	15 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Acceptance and Commitment Therapy
• Enhanced Usual Care

Conditions studied

• Tobacco Smoking — all drugs for Tobacco Smoking →
• Psychiatric Disorder — all drugs for Psychiatric Disorder →
• Psychiatric Hospitalization — all drugs for Psychiatric Hospitalization →

Sponsor

The Miriam Hospital

Who can join

18 and older, any sex, with Tobacco Smoking or Psychiatric Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study Primary · Through study completion, approximately 5 months.

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

Group	Value	95% CI
All Participants	17

Percentage of Counseling Sessions Completed Primary · through study completion, an average of 7 weeks.

number of scheduled counseling sessions completed

Group	Value	95% CI
Acceptance and Commitment Therapy	48
Enhanced Usual Care	80

Client Satisfaction Questionnaire Primary · at study completion, an average of 7 weeks post-enrollment

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)

Group	Value	95% CI
Acceptance and Commitment Therapy	27.00	± 6.63
Enhanced Usual Care	27.5	± 0.71

Number of Participants Who Are Rehospitalized for Psychiatric Reasons Primary · At study completion, an average of 7 weeks post enrollment

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.

Group	Value	95% CI
Acceptance and Commitment Therapy	0
Enhanced Usual Care	0

Number of Participants Who Are Abstinent From Tobacco Secondary · at study completion, an average of 7 weeks post enrollment

a simple count of those who have both a carbon monoxide value consistent with abstinence and self-reported abstinence. Expired carbon monoxide value of less than 6 parts per million was considered abstinent.

Group	Value	95% CI
Acceptance and Commitment Therapy	1
Enhanced Usual Care	0

Kessler 6 Secondary · Change between baseline and study completion, 7 weeks post-enrollment

Kessler 6, global distress measure, minimum value=0, maximum value=24, higher scores = greater distress (worse outcome), this study measures the change in global distress between enrollment and study completion. The change in global distress score minimum value=-24, maximum value=24 (lower scores indicate a better outcome: a reduction in distress)

Group	Value	95% CI
Acceptance and Commitment Therapy	-4.25	± 7.59
Enhanced Usual Care	-5.0	± 7.07

Avoidance Inflexibility Scale Secondary · Change between baseline and study completion, 7 weeks post-enrollment

The avoidance inflexibility scale is a 13-item self-report assessment in which respondents to consider how they respond to difficult thoughts that encourage smoking (e.g., "I need a cigarette", "I wish I could have a cigarette now!"), different feelings that encourage smoking (e.g., stress, fatigue, boredom, enjoyment, satisfaction, etc.), and bodily sensations that encourage smoking (e.g., "physical cravings or withdrawal symptoms").The Avoidance Inflexibility Scale measures smoking-related experiential avoidance, minimum score= 13, maximum score=65, higher score indicate more avoidance (wors

Group	Value	95% CI
Acceptance and Commitment Therapy	-9.25	± 15.69
Enhanced Usual Care	6.5	± 6.36

Commitment to Quitting Scale Secondary · Change between baseline and study completion, 7 weeks post-enrollment

Commitment to Quitting Scale, range 8-40, higher scores indicate greater commitment, commitment will be measured as the change between baseline and study completion, 7 weeks post enrollment.

Group	Value	95% CI
Acceptance and Commitment Therapy	4.25	± 7.63
Enhanced Usual Care	4.5	± 4.95

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.