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Modification of Goal-directed and Habitual Behavior in Addiction

Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03764969
Enrollment
75
Registered
2018-12-05
Start date
2020-01-07
Completion date
2023-06-23
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Addiction, Nicotine, Smoking Cessation, Relapse, Craving, habitual behavior, cognitive remediation, implicit priming, pavlovian instrumental transfer

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.

Detailed description

In this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. The first intervention is cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. The second intervention, a computer-based habit-modifying training focusing on implicit drug seeking (implicit computer-based habit-modifying training, ICHT) uses a conditioning approach through implicit priming and contextual modulation. Indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm. The investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly increase cognitive control, in contrast, ICHT should affect the early processing and the emotional valence of smoking and smoking cues.

Interventions

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.

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).

BEHAVIORALImplicit computer-based habit-modifying training (ICHT)

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.

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * common

Design outcomes

Primary

MeasureTime frameDescription
Change in cognitive flexibility3 time points: before and after 6 weeks SCP plus after 3 monthsInternal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in smoking urges3 time points: before and after 6 weeks SCP plus after 3 monthsquestionnaire 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
Change in working memory capacity3 time points: before and after 6 weeks SCP plus after 3 monthsSpatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in planning ability3 time points: before and after 6 weeks SCP plus after 3 monthsOne Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in imbalance between goal-directed and habitual behavior2 time points: before and after 6 weeks SCPmeasured by reward devaluation procedure (Hogarth & Chase 2011)
Change in implicit smoking-related associations3 time points: before and after 6 weeks SCP plus after 3 monthssmoking-related implicit association task (Wiers et al. 2016).
Change in attentional bias to smoking cues3 time points: before and after 6 weeks SCP plus after 3 monthssmoking-related dot-probe task (Vollstädt-Klein et al. 2009).

Secondary

MeasureTime frameDescription
Change in neural PIT effect2 time points: before and after 6 weeks SCPPIT phase of a choice task (adapted from Hogarth & Chase 2011)
Change in neural cue reactivity2 time points: before and after 6 weeks SCPfMRI cue-reactivity task (Vollstädt-Klein et al. 2011)
nicotine consumption3 months follow-upself-report

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026