NCT04791137

Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design: Optimizing an Internet-delivered Cognitive Training Intervention to Reduce Anhedonia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a small-scale randomized controlled trial (RCT) using a 'Leapfrog' design (Blackwell, Woud, Margraf, \& Schönbrodt, 2019) with the aim of investigating feasibility of this design in the context of an RCT of an internet-delivered intervention. The leapfrog design will be applied to a simple cognitive training intervention, imagery cognitive bias modification (imagery CBM), completed over a four-week training period. The trial will start with the three arms described in the initial registration, but these will be removed and new arms added over the course of the trial on the basis of sequential Bayesian analyses.

Conditions

• Anhedonia
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Imagery cognitive bias modification	The imagery cognitive bias modification intervention is derived from that developed via experimental psychopathology research (e.g. Holmes et al., 2009) and adapted for clinical applications in the context of depression (e.g. Blackwell \& Holmes, 2010; Blackwell et al., 2015). The intervention is a series of training sessions in which participants listen to training scenarios consisting of descriptions of everyday situations, structured so that they start ambiguously but always end positively. Participants are instructed to imagine themselves in the situations described as the scenarios unfold. It is hypothesised that via repeatedly practising imagining positive resolutions for ambiguous situations in the training sessions, a bias is trained to automatically imagine positive resolutions for ambiguous situations encountered in daily life.

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-01-11
• Completion: 2022-01-11
• First posted: 2021-03-10
• Last updated: 2022-01-28

Locations

1 site across 1 country: Germany