AnhedoniaNCT04791137

Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

A study testing Imagery cognitive bias modification in people with Anhedonia and Depression, run by Ruhr University of Bochum at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anhedonia, Depression
What is being tested?: Imagery cognitive bias modification
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 188 participants
Where: 1 siteGermany
Study dates: 9 Apr 2021to 11 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

No exclusion criteria set

Trial locations and contacts

1 site in 1 country.

Germany1 site

Ruhr University of Bochum
Bochum, North Rhine-Westphalia, 44801

Other trials in Germany

About this study

Official title: Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design: Optimizing an Internet-delivered Cognitive Training Intervention to Reduce Anhedonia

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
Being tested: Imagery cognitive bias modification
Keywords: Cognitive Bias Modification, Mental Imagery, Leapfrog Design
Medical subject headings: Anhedonia, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Imagery cognitive bias modificationBehavioural
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.

Study groups in NCT04791137
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Imagery cognitive bias modification

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Post-intervention (4 weeks post-baseline).

Secondary outcomes (6)

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
Measured: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
GAD-7
A brief 7-item measure of generalized anxiety symptoms (Spitzer et al., 2006)
Measured: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Positive Mental Health Scale (PMH)
A 9-item questionnaire designed to assess positive mental health (Lukat et al., 2016)
Measured: 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)
A measure with two 15-item parallel forms designed to assess depression-relevant negative interpretation biases (Rochbacher \& Reinecke, 2014)
Measured: Baseline and post-intervention (4 weeks post-baseline)
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).
Measured: Baseline and post-intervention (4 weeks post-baseline)
Negative Effects Questionnaire - Short Form (NEQ)
A 20-item questionnaire designed to assess potential negative effects of psychological interventions (Rozental et al., 2019)
Measured: Post-intervention (4 weeks post-baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 202111 Jan 2022

First posted10 Mar 2021
Study start9 Apr 2021
Primary completion11 Jan 2022
Study completion11 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AnhedoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04791137
Sponsor's protocol ID: 365
Status last verified: Jan 2022
First submitted: 8 Mar 2021
Last updated: 28 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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
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.
PubMed 36330836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anhedonia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design: Optimizing an Internet-delivered Cognitive Training Intervention to Reduce Anhedonia
ClinicalTrials.gov ID: NCT04791137
Acronym / sponsor ID: 365
Conditions: Anhedonia, Depression
Keywords: Cognitive Bias Modification, Mental Imagery, Leapfrog Design
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: Ruhr University of BochumUniversity, hospital or other
Collaborators: Ludwig-Maximilians - University of Munich
Study start: 9 Apr 2021 (actual)
Primary completion: 11 Jan 2022 (actual)
Study completion: 11 Jan 2022 (actual)
First posted: 10 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5
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.

Arm	Type	Receives
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	Behavioral: Imagery cognitive bias modificationParticipants 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.
Standard imagery cognitive bias modification plus additional rationale and transfer instructions	Experimental	Behavioral: Imagery cognitive bias modificationParticipants 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.
Standard imagery cognitive bias modification with frequent brief sessions	Experimental	Behavioral: Imagery cognitive bias modificationParticipants 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.
Standard imagery cognitive bias modification with a less intensive schedule	Experimental	Behavioral: Imagery cognitive bias modificationParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

No exclusion criteria set

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Imagery cognitive bias modificationThe 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.	Behavioural	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

Primary outcome

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).

6 secondary outcomes

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)
GAD-7
Time frame: Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
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)
Ambiguous Scenarios Test for Depression (AST)
Time frame: Baseline and post-intervention (4 weeks post-baseline)
Prospective Imagery Test (PIT)
Time frame: Baseline and post-intervention (4 weeks post-baseline)
Negative Effects Questionnaire - Short Form (NEQ)
Time frame: Post-intervention (4 weeks post-baseline)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
BackgroundBlackwell, 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
Derived from this study: PubMed 36330836Blackwell 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.
Link for participants to enrolLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simon E Blackwell, Dr. phil. principal investigator

Ruhr University of Bochum

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Imagery cognitive bias modification in people with Anhedonia and Depression, run by Ruhr University of Bochum at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dimensional Anhedonia Rating Scale (DARS) (time frame: Post-intervention (4 weeks post-baseline).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04791137, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.