Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791137
• Other study ID #: 365
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: January 11, 2022

Study information

• Verified date: January 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: January 11, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Depression

Intervention

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.

Locations

Country	Name	City	State
Germany	Ruhr University of Bochum	Bochum	Nordrhein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spontaneous Use of Imagery Scale (SUIS)	A 12-item questionnaire assessing experience of spontaneous non-emotional mental imagery in daily life (Reisberg et al., 2003)	Baseline
Other	Credibility / Expectancy Questionnaire (CEQ)	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)	Baseline
Other	Feedback questionnaire	A questionnaire containing both rating scales and open questions for eliciting participants' feedback about the study and interventions completed (if applicable)	Post-intervention (4 weeks post-baseline)
Primary	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 = v2/2).	Post-intervention (4 weeks post-baseline).
Secondary	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	Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Secondary	GAD-7	A brief 7-item measure of generalized anxiety symptoms (Spitzer et al., 2006)	Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Secondary	Positive Mental Health Scale (PMH)	A 9-item questionnaire designed to assess positive mental health (Lukat et al., 2016)	Baseline, 1 week post-baseline, 2 weeks post-baseline, 3 weeks post-baseline, post-intervention (4 weeks post-baseline)
Secondary	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)	Baseline and post-intervention (4 weeks post-baseline)
Secondary	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).	Baseline and post-intervention (4 weeks post-baseline)
Secondary	Negative Effects Questionnaire - Short Form (NEQ)	A 20-item questionnaire designed to assess potential negative effects of psychological interventions (Rozental et al., 2019)	Post-intervention (4 weeks post-baseline)

External Links

•   Link for participants to enrol