Modification of Goal-directed and Habitual Behavior in Addiction

NCT ID: NCT03764969

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2023-06-23

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard smoking cessation program (SCP)

standard smoking cessation program

Group Type: ACTIVE_COMPARATOR

standard smoking cessation program (SCP)

Intervention Type: 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 + CRT

SCP plus cognitive remediation treatment (CRT)

Group Type: EXPERIMENTAL

standard smoking cessation program (SCP)

Intervention Type: 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.

Cognitive remediation treatment (CRT)

Intervention Type: 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 + ICHT

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

Group Type: EXPERIMENTAL

standard smoking cessation program (SCP)

Intervention Type: 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.

Implicit computer-based habit-modifying training (ICHT)

Intervention Type: 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.

Interventions

standard smoking cessation program (SCP)

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.

Intervention Type: BEHAVIORAL

Cognitive remediation treatment (CRT)

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).

Intervention Type: BEHAVIORAL

Implicit 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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
• positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
• psychotropic medication within the last 14 days
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Vollstädt-Klein, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Herta Flor, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Locations

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36698210 (View on PubMed)

Other Identifiers

TRR265 C01

Identifier Type: -

Identifier Source: org_study_id