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Completed

NCT Number: NCT04791137

Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruhr University of Bochum

Bochum, North Rhine-Westphalia, 44801, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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