The Study

Background & Design

Background

Cannabis dependence is frequently associated with impairments in affective-volitional self-regulation processes that substantially influence rehabilitative change. Despite demonstrable effects of established psychosocial interventions, treatment outcomes often remain unstable — with abstinence rates of approximately 25% and persistently high dropout rates.

These findings suggest that sustainable behavioural change is limited less by a lack of motivation than by difficulties in implementing and maintaining self-congruent goals under emotional distress.

Research Approach

The LEICa study examines the effectiveness of an integrative, nature-based approach to strengthening self-regulation capacity in people with cannabis use disorder.

View intervention

Three Complementary Theories

SDT

Self-Determination Theory (SDT)

Clarifies the motivational conditions under which goals are experienced as self-congruent

GLM

Good Lives Model (GLM)

Specifies the content and personal meaning of motivational goal orientations

PSI

PSI Theory

Explains how self-congruent goals are implemented — or fail to be implemented — under affective distress

Integration into PSRT

Theoretical framework: Integration of SDT, GLM and PSI theory into PSRT

Study Design

01

Study Type

Multicentre, interventional, randomised, controlled trial with two parallel treatment arms

02

Population

Inpatient rehabilitation patients (18–67 years) with cannabis dependence (ICD-10 F12.2)

03

Primary Endpoint

Primary endpoint: Affective-volitional self-regulation competencies (VCQ-S)

04

Secondary Endpoint

Secondary endpoint: Facets of impulsive behaviour (I-8)

05

Analysis

ITT analysis using linear mixed models (MMRM)

Project Timeline

2024

Ethics Approval

Approved by Ethics Committee MLU Halle-Wittenberg (No. 2024-212)

May 2025

Recruitment Start

Beginning of participant recruitment at both study centres

June 2025

Trial Registration

Registration in the DRKS (DRKS00037137)

Dec 2025

Protocol Version 1.0

Finalisation of the study protocol

2026

Protocol Publication

Submission and publication of the study protocol

Dec 2026

End of Recruitment

Planned completion of participant recruitment

2027

Results

Data analysis and publication of study results