Trial Outcomes & Findings for Integrated PRocess and StrategieS Training: I-PRESS Training (NCT NCT04882215)
NCT ID: NCT04882215
Last Updated: 2024-11-14
Results Overview
Number of people referred from NHS eligible for screening and those entering the intervention. This will be continuously monitored throughout the study period.
TERMINATED
NA
14 participants
From pre-intervention (Week 1) to post-intervention (Week 12).
2024-11-14
Participant Flow
Participant milestones
| Measure |
Adaptive Training (AT)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the Working Memory Updating (WMU) training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the Working Memory Updating (WMU) training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Overall Study
STARTED
|
14
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0
|
|
Overall Study
COMPLETED
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Adaptive Training (AT)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the Working Memory Updating (WMU) training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the Working Memory Updating (WMU) training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adaptive Training (AT)
n=14 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non-Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
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Total
n=14 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
53.14 years
STANDARD_DEVIATION 10.49 • n=14 Participants
|
—
|
53.14 years
STANDARD_DEVIATION 10.49 • n=14 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants
|
—
|
7 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
—
|
7 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
14 Participants
n=14 Participants
|
—
|
14 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: From pre-intervention (Week 1) to post-intervention (Week 12).Population: In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Number of people referred from NHS eligible for screening and those entering the intervention. This will be continuously monitored throughout the study period.
Outcome measures
| Measure |
Adaptive Training (AT)
n=42 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Feasibility of Recruitment Process.
|
33.33 % participants entered the intervention
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—
|
PRIMARY outcome
Timeframe: From pre-intervention (Week 1) to post-intervention (Week 12).Population: In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Number of people completing the intervention to assess drop-out rates. This will be continuously monitored throughout the study period.
Outcome measures
| Measure |
Adaptive Training (AT)
n=14 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Participants' Drop-out Rates
|
35.7 % of participants who dropped out
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—
|
PRIMARY outcome
Timeframe: From pre-intervention (Week 1) to post-intervention (Week 12).Population: From the N=14 people entering the AT group, N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Mean percentage of working memory training sessions completed (a total of eight) were calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Participants' Coherence and Adherence to the Intervention.
|
73.61 % of working memory sessions completed
Standard Deviation 19.2
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—
|
PRIMARY outcome
Timeframe: Post-intervention session (Week 12)Population: From the N=14 people entering the AT group, a total of N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Participant evaluation of the intervention using a study-specific questionnaire including eight 5-point Likert-scale agreement questions (scores of 1 to 5 with 1 being positive and 5 being negative). Mean feedback score was calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Feedback Questionnaire
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1.25 Average feedback score
Standard Deviation 0.31
|
—
|
SECONDARY outcome
Timeframe: Post-intervention session (week 12)Population: From the N=14 people entering the AT group, a total of N=7 people took part in the fMRI session. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Performance in visuospatial working memory using the visuospatial Matrix Updating fMRI task. Accuracy is calculated as the proportion of correct responses at low and high difficulty task trials. Post-intervention session was used to calculate this measure.
Outcome measures
| Measure |
Adaptive Training (AT)
n=7 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
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Visuospatial Working Memory Using the Visuospatial Matrix Updating fMRI Task
|
0.69 proportion of correct responses
Standard Deviation 0.25
|
—
|
SECONDARY outcome
Timeframe: Post-intervention session (Week 12)Population: From the N=14 people entering the AT group, a total of N=7 people took part in the fMRI session. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Performance on spatial working memory using the spatial n-back fMRI task as calculated by proportion of correct responses at low and high difficulty n-back task trials. Post-intervention session was used to calculate this measure.
Outcome measures
| Measure |
Adaptive Training (AT)
n=7 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
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Visuospatial Working Memory fMRI Task Accuracy Using the Spatial N-back fMRI Task
|
0.78 proportion of correct responses
Standard Deviation 0.14
|
—
|
SECONDARY outcome
Timeframe: Post-intervention session (Week 12)Population: From the N=14 people entering the AT group, a total of N=7 people took part in the fMRI session. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Performance on visual episodic memory using the Object-location association fMRI task calculated by the proportion of correct responses at low and high difficulty level task trials. Post-intervention session was used to calculate this measure.
Outcome measures
| Measure |
Adaptive Training (AT)
n=7 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
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Episodic Visual Memory Accuracy Using the Object-location Association fMRI Task.
|
0.58 proportion of correct responses
Standard Deviation 0.15
|
—
|
SECONDARY outcome
Timeframe: Pre-intervention (Week 1) and post-intervention (Week 12)Population: From the N=14 people entering the AT group, a total of N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials. Higher score indicates a worse outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
|
Changes in Shifting Attention Using the Intra-Extra Dimensional Set Shift Test Variant From CANTAB Connect Research Web-testing.
|
10.11 % change between pre and post scores
Standard Deviation 80
|
—
|
SECONDARY outcome
Timeframe: Pre-intervention (Week 1) and post-intervention (Week 12)Population: From the N=14 people entering the AT group, a total of N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
Number of assessed problems that the participant successfully completed in the minimum possible number of moves. Calculated over all assessed trials. Higher score indicates a better outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
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|---|---|---|
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Changes in Spatial Planning and Problem Solving Using the Stockings of Cambridge Test Variant From CANTAB Connect Research Web-testing.
|
6.33 % change between pre and post scores
Standard Deviation 30.75
|
—
|
SECONDARY outcome
Timeframe: Pre-intervention (Week 1) and post-intervention (Week 12)Population: From the N=14 people entering the AT group, a total of N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials. Higher score indicates a worse outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
|
Changes in Spatial Working Memory Using the Spatial Working Memory Test Variant From CANTAB Connect Research Web-testing.
|
19.72 % change between pre and post scores
Standard Deviation 48.64
|
—
|
SECONDARY outcome
Timeframe: Pre-intervention (Week 1) and post-intervention (Week 12)Population: From the N=14 people entering the AT group, a total of N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
The Spatial Span forward test variant from CANTAB connect research web-testing was used calculated by the longest sequence of boxes successfully recalled by the participant. Higher score indicates a better outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
|
Changes in Visuospatial Working Memory Using the Spatial Span Forward Test Variant From CANTAB Connect Research Web-testing.
|
3.70 % change between pre and post scores
Standard Deviation 18.22
|
—
|
SECONDARY outcome
Timeframe: Pre-intervention (Week 1) and Post-intervention (Week 12)Population: From the N=14 people entering the AT group, a total of N=5 dropped out and therefore we analysed data from the remaining N=9 individuals. In the context of disruptions associated with COVID-19, a decision was made to focus on testing the feasibility of running the experimental condition (Adaptive training) initially and therefore no participant was assigned in the control group (Non-Adaptive training).
The Spatial Span reverse test variant from CANTAB connect research web-testing was used calculated by the longest sequence of boxes successfully recalled. Higher score indicates a better outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Outcome measures
| Measure |
Adaptive Training (AT)
n=9 Participants
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the AT group, difficulty of the WMU training tasks is progressively increased in response to task performance.
|
Non Adaptive Training (NA)
Participants in this group receive a combination of Goal Management Training (GMT) and computerised Working Memory Updating (WMU). For participants in the NA group, difficulty of the WMU training tasks remains at a relatively low level throughout the training period.
|
|---|---|---|
|
Changes in Visuospatial Working Memory Using the Spatial Span Reverse Test Variant From CANTAB Connect Research Web-testing.
|
14.89 % change between pre and post scores
Standard Deviation 37.12
|
—
|
Adverse Events
Adaptive Training (AT)
Non-Adaptive Training (NA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place