Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

NCT04791137 | Completed

• 1 other identifier: 365
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Anhedonia; Depression

Keywords

Cognitive Bias Modification; Mental Imagery; Leapfrog Design

Outcome Measures

Primary Outcomes (1)

• Dimensional Anhedonia Rating Scale (DARS)

  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).

  Post-intervention (4 weeks post-baseline).

Secondary Outcomes (6)

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS)

  Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)

• GAD-7

  Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)

• Positive Mental Health Scale (PMH)

  Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)

• Ambiguous Scenarios Test for Depression (AST)

  Baseline and post-intervention (4 weeks post-baseline)

• Prospective Imagery Test (PIT)

  Baseline and post-intervention (4 weeks post-baseline)

Other Outcomes (3)

• Spontaneous Use of Imagery Scale (SUIS)

  Baseline

• Credibility / Expectancy Questionnaire (CEQ)

  Baseline

• Feedback questionnaire

  Post-intervention (4 weeks post-baseline)

Study Arms (5)

Monitoring

NO INTERVENTION

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

Standard imagery cognitive bias modification

EXPERIMENTAL

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

Standard imagery cognitive bias modification plus additional rationale and transfer instructions

EXPERIMENTAL

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

Standard imagery cognitive bias modification with frequent brief sessions

EXPERIMENTAL

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

Standard imagery cognitive bias modification with a less intensive schedule

EXPERIMENTAL

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

Interventions

Imagery cognitive bias modification BEHAVIORAL

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.

Standard imagery cognitive bias modification; Standard imagery cognitive bias modification plus additional rationale and transfer instructions; Standard imagery cognitive bias modification with a less intensive schedule; Standard imagery cognitive bias modification with frequent brief sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Ruhr University of Bochum

Bochum, North Rhine-Westphalia, 44801, Germany

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 36330836 DERIVED

Related Links

• Link for participants to enrol

MeSH Terms

Conditions

Anhedonia; Depression

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Simon E Blackwell, Dr. phil.

  Ruhr-Universität Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: April 9, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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).

Locations

DE (1)