Back to resultsBayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Imagery Cognitive Bias Modification
Cognitive Control Training
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Anhedonia, Cognitive Bias Modification, Cognitive Control Training, Bayesian sequential analyses, Single case series
Eligibility Criteria
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)
- 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
Sites / Locations
- Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of BochumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Imagery Cognitive Bias Modification First
Cognitive Control Training First
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Positive Mental Health Scale (PMH)
The PMH (Lukat et al., 2016) consists of 9 items designed to assess positive mental health.
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.
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.
Full Information
NCT ID
NCT04779437
First Posted
February 28, 2021
Last Updated
February 6, 2023
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT04779437
Brief Title
Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work
Official Title
Using Bayesian Sequential Single Case Methodology to Personalize Low-Intensity Psychological Interventions for Depression: Initial Pilot Work
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Anhedonia, Cognitive Bias Modification, Cognitive Control Training, Bayesian sequential analyses, Single case series
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study is an exploratory single-case series using a within-subject ABC design, with a baseline phase (A) followed by two intervention phases (B) and (C). Participants are randomly assigned to the order in which they complete the two different interventions.
Masking
None (Open Label)
Masking Description
Two active interventions are used, and both participants and researchers are aware of which intervention participants are completing.
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imagery Cognitive Bias Modification First
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Control Training First
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imagery Cognitive Bias Modification
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Control Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)
Description
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)
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
Description
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)
Title
Dimensional Anhedonia Rating Scale (DARS)
Description
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)
Title
Positive and Negative Affect Schedule - Positive subscale (PANAS-P)
Description
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)
Title
GAD-7
Description
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)
Title
Positive Mental Health Scale (PMH)
Description
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)
Title
Prospective Imagery Test (PIT)
Description
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)
Title
Daily Expressions of Psychopathology (DEP)
Description
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)
Other Pre-specified Outcome Measures:
Title
Feedback questionnaires
Description
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.
Time Frame
Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Title
Negative Effects Questionnaire (NEQ)
Description
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.
Time Frame
Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
Title
Credibility / Expectancy Questionnaires (CEQ)
Description
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.
Time Frame
Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon E Blackwell, Dr. phil.
Phone
+49 (0) 234 32-21503
Email
simon.blackwell@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon E Blackwell, Dr. phil.
Organizational Affiliation
Ruhr-Universität Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon E Blackwell, Dr. phil.
Phone
+49 (0)234 32 - 21503
Email
simon.blackwell@rub.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://osf.io/qcwfx/
Learn more about this trial
Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work
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