The study is an initial investigation of the feasibility of applying Bayesian sequential analyses to individual participant single-case data for rapid detection of whether or not the individual is benefitting from a low-intensity computerized cognitive training intervention for depression. Patients waiting for, or in follow-up from, outpatient psychological therapy will complete first a two-week period of daily symptom monitoring, followed by two different two-week cognitive training interventions. Data collected will be used to assess feasibility of a future formal case series using Bayesian sequential analyses to determine switching of interventions, and inform the analysis parameters for such a future study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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. The training aims to train a bias to automatically imagine positive resolutions for ambiguous situations encountered in daily life. Participants will complete one introductory session of the training with the researcher present (in the outpatient center, or via videoconferencing software), then 8 sessions over two weeks completed from home via the study website.
The cognitive control training is an adaptive Paced Auditory Serial Addition Task (PASAT), adapted from that applied in previous studies (e.g. Siegle et al., 2007; Hoorelbeke et al., 2015; Blackwell et al., 2018). Participants will complete one introductory session of the training with the researcher present (in the outpatient center, or via videoconferencing software), then 8 sessions over two weeks completed from home via the study website.
Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany
Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)
The QIDS-daily is an adapted version of the QIDS-SR (Rush et al., 2003), which asks about symptoms over the past day and does not include the weight gain/loss items (as used by Holmes et al., 2016). The QIDS-daily will be completed daily over the entire study period, and we will compare the mean and slope of the daily QIDS over the intervention phase to the mean and slope of the daily QIDS in the previous phase.
Time frame: End of intervention (4 weeks post-baseline)
Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
The standard QIDS-SR (Rush et al., 2003) is a measure of depression symptoms asking about symptoms over the past seven days.
Time frame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Dimensional Anhedonia Rating Scale (DARS)
The DARS (Rizvi et al., 2015) is a 17-item self-report measure of different facets of anhedonia (desire, motivation, effort and consummatory pleasure) across different hedonic domains (hobbies/past-times, food/drinks, social activities, and sensory experiences).
Time frame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Positive and Negative Affect Schedule - Positive subscale (PANAS-P)
This 18-item positive subscale comprises the Joviality, Self-Assurance, and Attentiveness subscales of the extended PANAS (PANAS-X; Watson \& Clark, 1994), and in the current study asks about experience of positive emotions over the past week.
Time frame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
GAD-7
The GAD-7 (Spitzer et al., 2006) is a brief (7 items) self-report anxiety questionnaire designed as a screener for Generalized Anxiety Disorder in primary care.
Time frame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Positive Mental Health Scale (PMH)
The PMH (Lukat et al., 2016) consists of 9 items designed to assess positive mental health.
Time frame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Prospective Imagery Test (PIT)
The PIT (Stöber, 2000) is a measure of the vividness with which participants can imagine positive events in their future. In the current study, two 10-item (5 positive and 5 negative) versions are used, with the order counterbalanced across participants.
Time frame: Baseline, end of study (6 weeks post-baseline)
Daily Expressions of Psychopathology (DEP)
From 26/10/22 onwards, the DEP is used in addition to the QIDS as a daily measure (completed after the QIDS each day). Nine questions in total were taken (from Wright \& Zimmermann, 2021): three depression items, three anxiety items, and three anhedonia items. Participants are asked to rate each item according to much they applied in the past 24 hours, and using a scale from 0 (did not apply at all) to 6 (Applied very strongly). The DEP will be completed daily over the entire study period, and we will compare the mean and slope of the daily DEP over the intervention phase to the mean and slope of the daily DEP in the previous phase.
Time frame: End of intervention (4 weeks post-baseline)
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