Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

• ClinicalTrials.gov Identifier: NCT04791137
• Recruitment Status: Completed
• First Posted: March 10, 2021
• Last Update Posted: January 28, 2022
• Sponsor: Ruhr University of Bochum
• Collaborator: Ludwig-Maximilians - University of Munich
• Information provided by (Responsible Party): Simon Blackwell, Ruhr University of Bochum

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anhedonia; Depression	Behavioral: Imagery cognitive bias modification	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Participant)
• Masking Description: Participants are not blind as to whether they are receiving an intervention or monitoring only, but otherwise are blind to the status of which intervention they are receiving, i.e. 'original' version of the imagery CBM or an attempted improvement. Researchers are not blind to participant allocations, but the study is planned to be mostly automated, reducing opportunities to influence participants. Researchers will monitor performance of the arms as data accumulates, via the sequential analyses, and will therefore not be blind to outcomes as the trial progresses.
• Primary Purpose: Treatment
• Official Title: Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design: Optimizing an Internet-delivered Cognitive Training Intervention to Reduce Anhedonia
• Actual Study Start Date: April 9, 2021
• Actual Primary Completion Date: January 11, 2022
• Actual Study Completion Date: January 11, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Monitoring; Participants complete weekly questionnaires (QIDS-SR, PMH, GAD-7) on a weekly basis but receive no intervention.
Experimental: Standard imagery cognitive bias modification; 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.	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.
Experimental: Standard imagery cognitive bias modification plus additional rationale and transfer instructions; 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.	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.
Experimental: Standard imagery cognitive bias modification with frequent brief sessions; 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.	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.
Experimental: Standard imagery cognitive bias modification with a less intensive schedule; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Dimensional Anhedonia Rating Scale (DARS) [ Time Frame: Post-intervention (4 weeks post-baseline). ]
   A 17-item scale measuring anhedonia (Rizvi et al., 2015). The primary analysis is a between-groups comparison of post-intervention scores, controlling for baseline scores, using constrained longitudinal data analysis (cLDA). An approximate Bayes factor is then calculated via the t-statistic for the Time x Group effect with a directional default Cauchy prior (rscale parameter = √2/2).

Secondary Outcome Measures :

1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS) [ Time Frame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline) ]
   A 15-item version of the QIDS (Rush et al., 2013), excluding the suicidal ideation item, will be used
2. GAD-7 [ Time Frame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline) ]
   A brief 7-item measure of generalized anxiety symptoms (Spitzer et al., 2006)
3. Positive Mental Health Scale (PMH) [ Time Frame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline) ]
   A 9-item questionnaire designed to assess positive mental health (Lukat et al., 2016)
4. Ambiguous Scenarios Test for Depression (AST) [ Time Frame: Baseline and post-intervention (4 weeks post-baseline) ]
   A measure with two 15-item parallel forms designed to assess depression-relevant negative interpretation biases (Rochbacher & Reinecke, 2014)
5. Prospective Imagery Test (PIT) [ Time Frame: Baseline and post-intervention (4 weeks post-baseline) ]
   A measure designed to assess vividness of positive and negative future-oriented imagery (Stöber et al., 2000), here administered with as two 10-item parallel versions (each with 5 positive and 5 negative items).
6. Negative Effects Questionnaire - Short Form (NEQ) [ Time Frame: Post-intervention (4 weeks post-baseline) ]
   A 20-item questionnaire designed to assess potential negative effects of psychological interventions (Rozental et al., 2019)

Other Outcome Measures:

1. Spontaneous Use of Imagery Scale (SUIS) [ Time Frame: Baseline ]
   A 12-item questionnaire assessing experience of spontaneous non-emotional mental imagery in daily life (Reisberg et al., 2003)
2. Credibility / Expectancy Questionnaire (CEQ) [ Time Frame: Baseline ]
   A 6-item questionnaire assessing participants' evaluation of the credibility of an intervention (3 items) and their expectancy of symptom improvement (3 items) over the course of an intervention (Devilly & Borkovec, 2000)
3. Feedback questionnaire [ Time Frame: Post-intervention (4 weeks post-baseline) ]
   A questionnaire containing both rating scales and open questions for eliciting participants' feedback about the study and interventions completed (if applicable)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

Ruhr University of Bochum

Bochum, Nordrhein-Westfalen, Germany, 44801

Sponsors and Collaborators

Ruhr University of Bochum

Ludwig-Maximilians - University of Munich

Investigators

• Principal Investigator: Simon E Blackwell, Dr. phil.; Ruhr-Universität Bochum

More Information

Additional Information:

Link for participants to enrol 

Publications:

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

• Responsible Party: Simon Blackwell, Postdoctoral Researcher, Ruhr University of Bochum
• ClinicalTrials.gov Identifier: NCT04791137
• Other Study ID Numbers: 365
• First Posted: March 10, 2021
• Last Update Posted: January 28, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Anonymised data will be made available on publication via a suitable repository such as the Open Science Framework, and will be made available to reviewers at the time of submission (or publically with a pre-print version of the manuscript). Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Analytic Code
• Time Frame: Supporting information will be made available on publication via a suitable repository such as the Open Science Framework, and will be made available to reviewers at the time of submission (or publically with a pre-print version of the manuscript).
• URL: https://osf.io/8mxda/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simon Blackwell, Ruhr University of Bochum:

Cognitive Bias Modification; Mental Imagery; Leapfrog Design

Additional relevant MeSH terms:

Anhedonia; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases