Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work

Using Bayesian Sequential Single Case Methodology to Personalize Low-Intensity Psychological Interventions for Depression: Initial Pilot Work

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 Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Imagery Cognitive Bias Modification; Behavioral: Cognitive Control Training

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient registered at the Ruhr University of Bochum Outpatient Psychotherapy Center ("Zentrum für Psychotherapie", ZPT) in an appropriate phase of treatment (on waiting list/ in follow-up), or from 26/10/22 having had a first consultation ("Beratungsgespräch")
• Aged 18 years or above
• Owning a technical device (e.g. a laptop, computer) that is compatible with the computerized training
• Scoring ≥ 6 on the QIDS (indicating at least mild levels of depressive symptoms)
• Willing and able to complete all study procedures

Exclusion Criteria:

• Existence of a condition or circumstances that would interfere with completion of the study procedures (e.g. severe visual impairment, neurological problem, acute psychosis, or substance withdrawal symptoms)
• Acute crisis with high levels of suicidal ideations or high levels of self-harm, identified either through therapist's assessment or score >1 on item 12 of the QIDS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imagery Cognitive Bias Modification First; After completing two weeks of daily QIDS (baseline phase), participants randomly allocated to this arm will complete two weeks of imagery cognitive bias modification followed by two weeks of cognitive control training. Daily QIDS will be completed throughout the intervention phases.	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. 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.; Behavioral: Cognitive Control Training; 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.
Experimental: Cognitive Control Training First; After completing two weeks of daily QIDS (baseline phase), participants randomly allocated to this arm will complete two weeks of cognitive control training followed by two weeks of imagery cognitive bias modification. Daily QIDS will be completed throughout the intervention phases.	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. 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.; Behavioral: Cognitive Control Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of intervention (4 weeks post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	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.	End of intervention (4 weeks post-baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback questionnaires	Feedback questionnaires will be used at the end of each intervention phase, asking about the intervention just completed. Further feedback about the study as a whole will be collected on study completion.	Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Negative Effects Questionnaire (NEQ)	The NEQ (Rozental et al., 2019) asks about potential negative effects of psychological interventions. The short (20-item) version is used, adapted to ask about the cognitive training interventions.	Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Credibility / Expectancy Questionnaires (CEQ)	The CEQ (Devilly & Borkovec, 2000) asks participants' assessment of the credibility of the intervention they are about to receive, and their expectation of improvement in symptoms over the course of the intervention. In this study it will be administered before each phase: prior to baseline phase (about completing daily questionnaires), and prior to each intervention phase, about the imagery CBM and Cognitive Control Training as appropriate.	Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline)

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Simon E Blackwell, Dr. phil., Ruhr-Universität Bochum

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anhedonia; Cognitive Control Training; Cognitive Bias Modification; Bayesian sequential analyses; Single case series
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 publicly 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 Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No