Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

Ruhr University of Bochum

Status: Completed

Conditions: Anhedonia; Depression

Treatments: Behavioral: Imagery cognitive bias modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04791137

365

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or over
• Fluent German
• Willing and able to complete all study procedures (including having a suitable device/ internet access)
• Interested in monitoring their mood over the study time-period (one month)
• Score of ≥ 6 on the Quick Inventory of Depressive Symptomatology, including ≥ 1 on item 13 (General Interest), indicating at least mild levels of depression symptoms and anhedonia

Exclusion criteria

• No exclusion criteria set

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 5 patient groups

Monitoring

No Intervention group

Description:

Participants complete weekly questionnaires (QIDS-SR, PMH, GAD-7) on a weekly basis but receive no intervention.

Standard imagery cognitive bias modification

Experimental group

Description:

Participants are scheduled to complete a first introductory session then 12 further training sessions of a 'standard' imagery cognitive bias modification (CBM) intervention derived from that implemented in previous studies.

Treatment:

Behavioral: Imagery cognitive bias modification

Standard imagery cognitive bias modification plus additional rationale and transfer instructions

Experimental group

Description:

Participants are scheduled to complete a first introductory session then 12 further training sessions of a 'standard' imagery cognitive bias modification (CBM) intervention, but in addition are first presented with a more extended rationale for completing the training, and during each training session are provided with instructions to practice retrieval and rehearsal of the training contents in between sessions.

Treatment:

Behavioral: Imagery cognitive bias modification

Standard imagery cognitive bias modification with frequent brief sessions

Experimental group

Description:

Participants are scheduled to complete a first introductory session then 40 brief (\~5 min) sessions of a 'standard' imagery cognitive bias modification (CBM) intervention, with 2 per day five days per week for each of the four training weeks. In addition, as with the arm "Standard imagery cognitive bias modification plus additional rationale and transfer instructions", participants are first presented with a more extended rationale for completing the training, and during many of the training sessions are provided with instructions to practice retrieval and rehearsal of the training contents in between sessions. This arm was added into the ongoing trial on 30.05.21.

Treatment:

Behavioral: Imagery cognitive bias modification

Standard imagery cognitive bias modification with a less intensive schedule

Experimental group

Description:

Participants are scheduled to complete a first introductory session then 11 further sessions of a 'standard' imagery cognitive bias modification (CBM) intervention, with 3 sessions scheduled for each of the four training weeks. Sessions have fewer training scenarios than the "Standard imagery cognitive bias modification" condition and more varied task instructions. In addition, as with the arm "Standard imagery cognitive bias modification plus additional rationale and transfer instructions", participants are first presented with a more extended rationale for completing the training, and during many of the training sessions are provided with instructions to practice retrieval and rehearsal of the training contents in between sessions. This arm was added into the ongoing trial on 09.06.21.

Treatment:

Behavioral: Imagery cognitive bias modification