Modification of Goal-directed and Habitual Behavior in Addiction

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT); Behavioral: Implicit computer-based habit-modifying training (ICHT)

• Registration Number: NCT03764969
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2020-01-07
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 exclusion criteria for MRI (e.g. metal, claustrophobia)
• positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
• psychotropic medication within the last 14 days
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCP + CRT	standard smoking cessation program (SCP)	SCP plus cognitive remediation treatment (CRT)
standard smoking cessation program (SCP)	standard smoking cessation program (SCP)	standard smoking cessation program
SCP + CRT	Cognitive remediation treatment (CRT)	SCP plus cognitive remediation treatment (CRT)
SCP + ICHT	standard smoking cessation program (SCP)	SCP plus an implicit computer-based habit-modifying training (ICHT)
SCP + ICHT	Implicit computer-based habit-modifying training (ICHT)	SCP plus an implicit computer-based habit-modifying training (ICHT)

Primary Outcome Measures

Name	Time	Method
Change in smoking urges	3 time points: before and after 6 weeks SCP plus after 3 months	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
Change in attentional bias to smoking cues	3 time points: before and after 6 weeks SCP plus after 3 months	smoking-related dot-probe task (Vollstädt-Klein et al. 2009).
Change in planning ability	3 time points: before and after 6 weeks SCP plus after 3 months	One 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 behavior	2 time points: before and after 6 weeks SCP	measured by reward devaluation procedure (Hogarth \& Chase 2011)
Change in implicit smoking-related associations	3 time points: before and after 6 weeks SCP plus after 3 months	smoking-related implicit association task (Wiers et al. 2016).
Change in working memory capacity	3 time points: before and after 6 weeks SCP plus after 3 months	Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in cognitive flexibility	3 time points: before and after 6 weeks SCP plus after 3 months	Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

Secondary Outcome Measures

Name	Time	Method
Change in neural cue reactivity	2 time points: before and after 6 weeks SCP	fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)
nicotine consumption	3 months follow-up	self-report
Change in neural PIT effect	2 time points: before and after 6 weeks SCP	PIT phase of a choice task (adapted from Hogarth \& Chase 2011)

Trial Locations

Locations (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit; 🇩🇪 Mannheim, Baden-Württemberg, Germany