DepressionNCT04779437
Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work
A study testing Imagery Cognitive Bias Modification in people with Depression, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Imagery Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- 17 Mar 2021to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, 44787
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Imagery Cognitive Bias Modification, Cognitive Control Training
- Keywords
- Depression, Anhedonia, Cognitive Bias Modification, Cognitive Control Training, Bayesian sequential analyses, Single case series
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Cognitive Bias ModificationBehavioural
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.
Cognitive Control TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Imagery Cognitive Bias Modification First | Experimental | 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. Receives: Behavioral: Imagery Cognitive Bias Modification; Behavioral: Cognitive Control Training |
| Cognitive Control Training First | Experimental | 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. Receives: Behavioral: Imagery Cognitive Bias Modification; Behavioral: Cognitive Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of intervention (4 weeks post-baseline)
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of intervention (4 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start17 Mar 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Blackwell, Ruhr University of Bochum
- Investigators
- Simon E Blackwell, Dr. phil., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779437
- Sponsor's protocol ID
- 650
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Bayesian Sequential Single Case Methodology to Personalize Low-Intensity Psychological Interventions for Depression: Initial Pilot Work
- ClinicalTrials.gov ID
- NCT04779437
- Acronym / sponsor ID
- 650
- Conditions
- Depression
- Keywords
- Depression, Anhedonia, Cognitive Bias Modification, Cognitive Control Training, Bayesian sequential analyses, Single case series
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Imagery Cognitive Bias Modification First | Experimental | Behavioral: Imagery Cognitive Bias Modification, Behavioral: Cognitive Control TrainingAfter 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. |
| Cognitive Control Training First | Experimental | Behavioral: Imagery Cognitive Bias Modification, Behavioral: Cognitive Control TrainingAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery Cognitive Bias ModificationThe 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. | Behavioural | Cognitive Control Training First, Imagery Cognitive Bias Modification First |
| Cognitive Control TrainingThe 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. | Behavioural | Cognitive Control Training First, Imagery Cognitive Bias Modification First |
Primary outcome
Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)
Time frame: End of intervention (4 weeks post-baseline)
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.
7 secondary outcomes
Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
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)
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)
Time frame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
GAD-7
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)
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)
Time frame: Baseline, end of study (6 weeks post-baseline)
Daily Expressions of Psychopathology (DEP)
Time frame: End of intervention (4 weeks post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon E Blackwell, Dr. phil. principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Cognitive Bias Modification in people with Depression, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily) (time frame: End of intervention (4 weeks post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.