Clinical trial NCT04791137: Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design
Official title: Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design: Optimizing an Internet-delivered Cognitive Training Intervention to Reduce Anhedonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anhedonia
Depression
Keywords: Cognitive Bias Modification
Mental Imagery
Leapfrog Design
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2021-03-10
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The leapfrog trial design is a parallel-arm design in which participants and randomly allocated to one of several treatment arms on a 1:1:1... ratio. One trial arm is designated the comparison arm, and all other arms are compared to this comparison arm via sequential Bayesian analyses. Depending on the outcomes of the sequential analyses (based on reaching Bayes Factor thresholds for 'success' or 'failure', trial arms may be removed, or take the place of the comparison arm while the trial is ongoing, and new arms may also be introduced into an ongoing trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Post-intervention (4 weeks post-baseline).
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
timeFrame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
measure: GAD-7
timeFrame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
measure: Positive Mental Health Scale (PMH)
timeFrame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
measure: Ambiguous Scenarios Test for Depression (AST)
timeFrame: Baseline and post-intervention (4 weeks post-baseline)
measure: Prospective Imagery Test (PIT)
timeFrame: Baseline and post-intervention (4 weeks post-baseline)
measure: Negative Effects Questionnaire - Short Form (NEQ)
timeFrame: Post-intervention (4 weeks post-baseline)
Other outcomes:
measure: Spontaneous Use of Imagery Scale (SUIS)
timeFrame: Baseline
measure: Credibility / Expectancy Questionnaire (CEQ)
timeFrame: Baseline
measure: Feedback questionnaire
timeFrame: Post-intervention (4 weeks post-baseline)
Locations:
city: Bochum
country: Germany
facility: Ruhr University of Bochum
state: Nordrhein-Westfalen
Study officials:
affiliation: Ruhr-Universität Bochum
name: Simon E Blackwell, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blackwell, S. E., Woud, M. L., Margraf, J., & Schönbrodt, F. D. (2019). Introducing the leapfrog design: A simple Bayesian adaptive rolling trial design for accelerated treatment development and optimization. Clinical Psychological Science, 7, 1222-1243. https://doi.org/10.1177/2167702619858071
citation: Blackwell SE, Schonbrodt FD, Woud ML, Wannemuller A, Bektas B, Braun Rodrigues M, Hirdes J, Stumpp M, Margraf J. Demonstration of a 'leapfrog' randomized controlled trial as a method to accelerate the development and optimization of psychological interventions. Psychol Med. 2023 Oct;53(13):6113-6123. doi: 10.1017/S0033291722003294. Epub 2022 Nov 4.