Back to resultsFeasibility Randomized Controlled Trial Using a 'Leapfrog' Design
Primary Purpose
Anhedonia, Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Imagery cognitive bias modification
Sponsored by
About this trial
This is an interventional treatment trial for Anhedonia focused on measuring Cognitive Bias Modification, Mental Imagery, Leapfrog Design
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
Sites / Locations
- Ruhr University of Bochum
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Arm Label
Monitoring
Standard imagery cognitive bias modification
Standard imagery cognitive bias modification plus additional rationale and transfer instructions
Standard imagery cognitive bias modification with frequent brief sessions
Standard imagery cognitive bias modification with a less intensive schedule
Arm Description
Participants complete weekly questionnaires (QIDS-SR, PMH, GAD-7) on a weekly basis but receive no intervention.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
A 15-item version of the QIDS (Rush et al., 2013), excluding the suicidal ideation item, will be used
GAD-7
A brief 7-item measure of generalized anxiety symptoms (Spitzer et al., 2006)
Positive Mental Health Scale (PMH)
A 9-item questionnaire designed to assess positive mental health (Lukat et al., 2016)
Ambiguous Scenarios Test for Depression (AST)
A measure with two 15-item parallel forms designed to assess depression-relevant negative interpretation biases (Rochbacher & Reinecke, 2014)
Prospective Imagery Test (PIT)
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).
Negative Effects Questionnaire - Short Form (NEQ)
A 20-item questionnaire designed to assess potential negative effects of psychological interventions (Rozental et al., 2019)
Full Information
NCT ID
NCT04791137
First Posted
March 8, 2021
Last Updated
January 27, 2022
Sponsor
Ruhr University of Bochum
Collaborators
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT04791137
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
January 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
Collaborators
Ludwig-Maximilians - University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia, Depression
Keywords
Cognitive Bias Modification, Mental Imagery, Leapfrog Design
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring
Arm Type
No Intervention
Arm Description
Participants complete weekly questionnaires (QIDS-SR, PMH, GAD-7) on a weekly basis but receive no intervention.
Arm Title
Standard imagery cognitive bias modification
Arm Type
Experimental
Arm 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.
Arm Title
Standard imagery cognitive bias modification plus additional rationale and transfer instructions
Arm Type
Experimental
Arm 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.
Arm Title
Standard imagery cognitive bias modification with frequent brief sessions
Arm Type
Experimental
Arm 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.
Arm Title
Standard imagery cognitive bias modification with a less intensive schedule
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Imagery cognitive bias modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dimensional Anhedonia Rating Scale (DARS)
Description
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).
Time Frame
Post-intervention (4 weeks post-baseline).
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
Description
A 15-item version of the QIDS (Rush et al., 2013), excluding the suicidal ideation item, will be used
Time Frame
Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Title
GAD-7
Description
A brief 7-item measure of generalized anxiety symptoms (Spitzer et al., 2006)
Time Frame
Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Title
Positive Mental Health Scale (PMH)
Description
A 9-item questionnaire designed to assess positive mental health (Lukat et al., 2016)
Time Frame
Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Title
Ambiguous Scenarios Test for Depression (AST)
Description
A measure with two 15-item parallel forms designed to assess depression-relevant negative interpretation biases (Rochbacher & Reinecke, 2014)
Time Frame
Baseline and post-intervention (4 weeks post-baseline)
Title
Prospective Imagery Test (PIT)
Description
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).
Time Frame
Baseline and post-intervention (4 weeks post-baseline)
Title
Negative Effects Questionnaire - Short Form (NEQ)
Description
A 20-item questionnaire designed to assess potential negative effects of psychological interventions (Rozental et al., 2019)
Time Frame
Post-intervention (4 weeks post-baseline)
Other Pre-specified Outcome Measures:
Title
Spontaneous Use of Imagery Scale (SUIS)
Description
A 12-item questionnaire assessing experience of spontaneous non-emotional mental imagery in daily life (Reisberg et al., 2003)
Time Frame
Baseline
Title
Credibility / Expectancy Questionnaire (CEQ)
Description
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)
Time Frame
Baseline
Title
Feedback questionnaire
Description
A questionnaire containing both rating scales and open questions for eliciting participants' feedback about the study and interventions completed (if applicable)
Time Frame
Post-intervention (4 weeks post-baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon E Blackwell, Dr. phil.
Organizational Affiliation
Ruhr-Universität Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhr University of Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44801
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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).
IPD Sharing URL
https://osf.io/8mxda/
Citations:
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
Results Reference
background
PubMed Identifier
36330836
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.
Results Reference
derived
Links:
URL
https://homepage.ruhr-uni-bochum.de/Simon.Blackwell/mio-studie.html?st=lf3&so=c0
Description
Link for participants to enrol
Learn more about this trial
Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design
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