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Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure

NCT ID: NCT03707106

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-07-02

Brief Summary

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Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Professional recommendation of drug treatment besides nicotine-replacement aids is restrained considering side effects and contraindications. Currently, cue exposure is highly discussed as intervention for craving reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up to date.

However, this is the first randomized controlled study focusing on efficacy increases by VR cue exposure supporting an established CBT smoking cessation manual. The control group receives a specific stress reduction treatment (independent of smoking cues), namely, the Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established smoking cessation CBT.

Detailed Description

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Conditions

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Smoking Cessation

Keywords

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virtual reality cue exposure progressive muscle relaxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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VR based cue exposure smoking cessation

an established CBT intervention for smoking cessation supported by cue exposure in virtual reality

Group Type EXPERIMENTAL

CBT smoking cessation

Intervention Type BEHAVIORAL

an established protocol for smoking cessation based on cognitive behavioral therapy

virtual reality based cue exposure

Intervention Type BEHAVIORAL

smoking cue exposure in virtual reality

PMR supported smoking cessation

an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson)

Group Type ACTIVE_COMPARATOR

CBT smoking cessation

Intervention Type BEHAVIORAL

an established protocol for smoking cessation based on cognitive behavioral therapy

progressive muscle relaxation

Intervention Type BEHAVIORAL

Progressive muscle relaxation for unspecific stress reduction

Interventions

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CBT smoking cessation

an established protocol for smoking cessation based on cognitive behavioral therapy

Intervention Type BEHAVIORAL

virtual reality based cue exposure

smoking cue exposure in virtual reality

Intervention Type BEHAVIORAL

progressive muscle relaxation

Progressive muscle relaxation for unspecific stress reduction

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* daily smokers for at least 2 years, smoking minimum 10 cigarettes a day

Exclusion Criteria

* pregnancy
* current participation in another smoking cessation program within 6 months before assignment
* current diagnosis of a psychiatric disease including a depression or substance use disorder (excluding nicotine dependency)
* lifetime diagnosis of a psychiatric disease : psychosis, bipolar affective disorder, posttraumatic stress disorder, conversion disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regensburg

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Anil Batra

Deputy Head of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

University Regensburg

Regensburg, , Germany

Site Status

Countries

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Germany

References

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Kroczek AM, Schroder B, Rosenbaum D, Muhleck A, Diemer J, Muhlberger A, Ehlis AC, Batra A. Virtual reality cue exposure as an add-on to smoking cessation group therapy: a randomized controlled trial. Addict Sci Clin Pract. 2025 Apr 11;20(1):34. doi: 10.1186/s13722-025-00561-2.

Reference Type DERIVED
PMID: 40211338 (View on PubMed)

Other Identifiers

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70111871

Identifier Type: -

Identifier Source: org_study_id