NCT03764969

Brief Summary

This study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

3.5 years

First QC Date

November 28, 2018

Last Update Submit

October 4, 2023

Conditions

Tobacco Use Disorder

Keywords

AddictionNicotineSmoking CessationRelapseCravinghabitual behaviorcognitive remediationimplicit primingpavlovian instrumental transfer

Outcome Measures

Primary Outcomes (7)

  • Change in imbalance between goal-directed and habitual behavior

    measured by reward devaluation procedure (Hogarth \& Chase 2011)

    2 time points: before and after 6 weeks SCP

  • Change in implicit smoking-related associations

    smoking-related implicit association task (Wiers et al. 2016).

    3 time points: before and after 6 weeks SCP plus after 3 months

  • Change in attentional bias to smoking cues

    smoking-related dot-probe task (Vollstädt-Klein et al. 2009).

    3 time points: before and after 6 weeks SCP plus after 3 months

  • Change in smoking urges

    questionnaire of smoking urges (QSU, Müller et al. 2001)); self-report questionnaire; two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving

    3 time points: before and after 6 weeks SCP plus after 3 months

  • Change in working memory capacity

    Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

    3 time points: before and after 6 weeks SCP plus after 3 months

  • Change in planning ability

    One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

    3 time points: before and after 6 weeks SCP plus after 3 months

  • Change in cognitive flexibility

    Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

    3 time points: before and after 6 weeks SCP plus after 3 months

Secondary Outcomes (3)

  • nicotine consumption

    3 months follow-up

  • Change in neural PIT effect

    2 time points: before and after 6 weeks SCP

  • Change in neural cue reactivity

    2 time points: before and after 6 weeks SCP

Study Arms (3)

standard smoking cessation program (SCP)

ACTIVE COMPARATOR

standard smoking cessation program

Behavioral: standard smoking cessation program (SCP)

SCP + CRT

EXPERIMENTAL

SCP plus cognitive remediation treatment (CRT)

Behavioral: standard smoking cessation program (SCP)Behavioral: Cognitive remediation treatment (CRT)

SCP + ICHT

EXPERIMENTAL

SCP plus an implicit computer-based habit-modifying training (ICHT)

Behavioral: standard smoking cessation program (SCP)Behavioral: Implicit computer-based habit-modifying training (ICHT)

Interventions

standard smoking cessation program (SCP)BEHAVIORAL

Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra \& Buchkremer 2004), and will be carried out by a qualified therapist.

SCP + CRTSCP + ICHTstandard smoking cessation program (SCP)
Cognitive remediation treatment (CRT)BEHAVIORAL

Cognitive remediation treatment (CRT) employing a chess-based battery of tasks two times per week over six weeks as a group treatment in our outpatient clinic (60 min duration per session).

SCP + CRT
Implicit computer-based habit-modifying training (ICHT)BEHAVIORAL

Implicit computer-based habit-modifying training (ICHT), applied twice a week for six weeks. In this training, the participants perform a two-part training. First, a subliminal presentation (20 ms) of negative valenced primes before smoking-cues in context and secondly, a subliminal presentation of positive valenced primes before potentially reinforcing events.

SCP + ICHT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe tobacco use disorder (TUD) according to DSM-5
  • sufficient ability to communicate with investigators and answer questions in both written and verbal format
  • ability to provide fully informed consent and to use self-rating scales

You may not qualify if:

  • severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
  • history of brain injury
  • severe physical diseases
  • positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
  • psychotropic medication within the last 14 days
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (1)

  • Karl D, Wieland A, Shevchenko Y, Grundinger N, Machunze N, Gerhardt S, Flor H, Vollstadt-Klein S. Using computer-based habit versus chess-based cognitive remediation training as add-on therapy to modify the imbalance between habitual behavior and cognitive control in tobacco use disorder: protocol of a randomized controlled, fMRI study. BMC Psychol. 2023 Jan 25;11(1):24. doi: 10.1186/s40359-023-01055-z.

    PMID: 36698210DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderBehavior, AddictiveSmoking CessationRecurrence

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorHealth BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sabine Vollstädt-Klein, Prof. Dr.

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

  • Herta Flor, Prof. Dr.

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

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

November 28, 2018

First Posted

December 5, 2018

Study Start

January 7, 2020

Primary Completion

June 23, 2023

Study Completion

June 23, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

DE(1)