Trial Outcomes & Findings for A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination (NCT NCT04137367)
NCT ID: NCT04137367
Last Updated: 2025-02-05
Results Overview
Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.
COMPLETED
NA
108 participants
At 6 months follow-up
2025-02-05
Participant Flow
Participants were recruited between Nov 19, 2019, and Aug 17, 2021 using local advertisements and social media. Entrance to the trial was via self-referral by phone or online registration.
Did not meet the inclusion criteria (N=4), Declined to participate (n=4), Not able to get in contact with (N=4).
Participant milestones
| Measure |
Active Affective Bias Modification
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
Only assessments were conducted.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
7
|
|
Overall Study
COMPLETED
|
42
|
45
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
4
|
Reasons for withdrawal
| Measure |
Active Affective Bias Modification
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
Only assessments were conducted.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
4
|
Baseline Characteristics
Technical problems led to missing data for two participant.
Baseline characteristics by cohort
| Measure |
Active Affective Bias Modification
n=42 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=45 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assesment Only
n=5 Participants
No intervention.
|
Total
n=92 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Continuous
|
44.3 years
STANDARD_DEVIATION 10.4 • n=41 Participants • Technical problems led to missing data for two participant.
|
43.2 years
STANDARD_DEVIATION 11.6 • n=45 Participants • Technical problems led to missing data for two participant.
|
36.8 years
STANDARD_DEVIATION 18.2 • n=4 Participants • Technical problems led to missing data for two participant.
|
43.7 years
STANDARD_DEVIATION 11.0 • n=90 Participants • Technical problems led to missing data for two participant.
|
|
Sex: Female, Male
Female
|
28 Participants
n=42 Participants
|
36 Participants
n=45 Participants
|
3 Participants
n=5 Participants
|
67 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=42 Participants
|
9 Participants
n=45 Participants
|
2 Participants
n=5 Participants
|
25 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Norway
|
42 participants
n=42 Participants
|
45 participants
n=45 Participants
|
5 participants
n=5 Participants
|
92 participants
n=92 Participants
|
|
Education level (ISCED)
|
5.7 units on a scale
STANDARD_DEVIATION 1.3 • n=41 Participants • Technical problems led to missing data for two participants.
|
5.8 units on a scale
STANDARD_DEVIATION 1.2 • n=45 Participants • Technical problems led to missing data for two participants.
|
4.8 units on a scale
STANDARD_DEVIATION 2.1 • n=4 Participants • Technical problems led to missing data for two participants.
|
5.7 units on a scale
STANDARD_DEVIATION 1.3 • n=90 Participants • Technical problems led to missing data for two participants.
|
|
Beck's Depression Inventory (BDI-II)
|
23.1 units on a scale
STANDARD_DEVIATION 10.6 • n=41 Participants • Technical problems led to missing data for two participants.
|
26.3 units on a scale
STANDARD_DEVIATION 9.8 • n=45 Participants • Technical problems led to missing data for two participants.
|
18.2 units on a scale
STANDARD_DEVIATION 3.8 • n=4 Participants • Technical problems led to missing data for two participants.
|
24.4 units on a scale
STANDARD_DEVIATION 9.9 • n=90 Participants • Technical problems led to missing data for two participants.
|
|
Beck's Anxiety Inventory (BAI)
|
13.1 units on a scale
STANDARD_DEVIATION 8.8 • n=41 Participants • Technical problems led to missing data for one participant.
|
16.2 units on a scale
STANDARD_DEVIATION 8.9 • n=45 Participants • Technical problems led to missing data for one participant.
|
12.0 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants • Technical problems led to missing data for one participant.
|
14.6 units on a scale
STANDARD_DEVIATION 8.8 • n=91 Participants • Technical problems led to missing data for one participant.
|
|
Alcohol Use Disorder Identification Test (AUDIT)
|
5.8 units on a scale
STANDARD_DEVIATION 4.7 • n=41 Participants • Technical problems led to missing data for one participant.
|
5.5 units on a scale
STANDARD_DEVIATION 5.6 • n=45 Participants • Technical problems led to missing data for one participant.
|
3.6 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants • Technical problems led to missing data for one participant.
|
5.5 units on a scale
STANDARD_DEVIATION 5.6 • n=91 Participants • Technical problems led to missing data for one participant.
|
|
Brief State Rumination Inventory (BSRI)
|
36.4 units on a scale
STANDARD_DEVIATION 18.7 • n=41 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if it mediated the association between the intervention and the primary outcome.
|
38.3 units on a scale
STANDARD_DEVIATION 17.5 • n=45 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if it mediated the association between the intervention and the primary outcome.
|
22.3 units on a scale
STANDARD_DEVIATION 20.7 • n=5 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if it mediated the association between the intervention and the primary outcome.
|
36.6 units on a scale
STANDARD_DEVIATION 18.4 • n=91 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if it mediated the association between the intervention and the primary outcome.
|
|
Attentional bias
|
-10.7 milliseconds
STANDARD_DEVIATION 26.4 • n=41 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if the intervention modified its intended mechanism
|
-4.7 milliseconds
STANDARD_DEVIATION 36.0 • n=45 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if the intervention modified its intended mechanism
|
-17.1 milliseconds
STANDARD_DEVIATION 29.3 • n=5 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if the intervention modified its intended mechanism
|
-8.1 milliseconds
STANDARD_DEVIATION 15.9 • n=91 Participants • Technical problems led to missing data for one participant. Data for this outcome measure was only obtained at baseline and post-intervention, not at 6 months follow-up, as the intention of adopting this measure was to investigate if the intervention modified its intended mechanism
|
PRIMARY outcome
Timeframe: At 6 months follow-upPopulation: Participants that had baseline and/or outcome data.
Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.
Outcome measures
| Measure |
Active Affective Bias Modification
n=42 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=45 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
n=5 Participants
No intervention was given, only assessments were conducted.
|
|---|---|---|---|
|
Self-reported Depressive Symptoms: Becks Depression Inventory-II
|
19.1 score on a scale
Standard Error 1.7
|
16.5 score on a scale
Standard Error 1.6
|
5.3 score on a scale
Standard Error 5.5
|
PRIMARY outcome
Timeframe: At baseline and two weeks follow up.Population: 10 persons were lost to follow up
Change in self-reported state rumination after the stress induction from pre to post intervention on a 8 item scale. Difference score: BSRI post intervention - BRSI Baseline. A negative score means reduction in state rumination over the intervention. Each item is scored on a 0-100 Visual Analogue Scale. The total score divided by 8 to provide the mean item total score, hence the min= 0 and max = 100 for each of the BSRI assessment time points. It was hypothesized that change in state rumination over the intervention period would mediate the effect of ABM on depressive symptoms at six months follow up.
Outcome measures
| Measure |
Active Affective Bias Modification
n=37 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=41 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
n=4 Participants
No intervention was given, only assessments were conducted.
|
|---|---|---|---|
|
State Rumination: Brief State Rumination Inventory (BSRI)
|
-.7 score on a scale
Standard Deviation 13.3
|
-5.8 score on a scale
Standard Deviation 19.1
|
-.8 score on a scale
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: At two weeks follow up.Population: 10 participants were lost to follow-up.
Self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800, which is reported divided by 8 to provide a mean total item score. Hence the min= 0 and max = 100. A higher score indicates more state rumination.
Outcome measures
| Measure |
Active Affective Bias Modification
n=37 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=41 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
n=4 Participants
No intervention was given, only assessments were conducted.
|
|---|---|---|---|
|
State Rumination: Brief State Rumination Inventory
|
34.2 score on a scale
Standard Deviation 15.8
|
32.3 score on a scale
Standard Deviation 15.8
|
23.4 score on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: From baseline to two weeks follow upPopulation: Nine participants were lost to follow up. Technical error led to loss of data on the follow up in the assessment only condition.
Change in reaction time in milliseconds to probes in the location of the positive facial stimuli compared to probes in the location of the negative stimuli. Positive number implies reduction in negative bias.
Outcome measures
| Measure |
Active Affective Bias Modification
n=35 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=42 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
No intervention was given, only assessments were conducted.
|
|---|---|---|---|
|
Affective Bias: Dot-probe Task
|
18.0 milliseconds
Standard Deviation 28.4
|
9.4 milliseconds
Standard Deviation 40.3
|
—
|
SECONDARY outcome
Timeframe: From two weeks prior to baseline to two weeks after the two-week intervention.Population: Pre-processing of ESM-data excluded participants who responded to less than 30 measurements.
Changed centrality of rumination in networks estimated based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Two person-specific networks (pre and post-intervention) were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days before and after the intervention. Centrality of rumination in these networks were calculated using qgraph (Epskamp et al., 2012) and standardized. Change in rumination centrality was calculated as difference between rumination centrality in the two estimated networks, and higher number indicate increased centrality of rumination (post-pre).
Outcome measures
| Measure |
Active Affective Bias Modification
n=14 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=16 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
No intervention was given, only assessments were conducted.
|
|---|---|---|---|
|
Symptom Network Change: Experience Sampling of Depressive Symptoms
|
.0175 standardized values
Standard Deviation .0819
|
-.685 standardized values
Standard Deviation .789
|
—
|
SECONDARY outcome
Timeframe: Two weeks after the two-week intervention.Population: Participants who responded to 30 measurements or more.
Centrality of rumination in networks based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Person-specific networks were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days after the two-week intervention. Centrality of rumination in this network was calculated using qgraph (Epskamp et al., 2012) and standardized. Higher number indicate higher centrality of rumination.
Outcome measures
| Measure |
Active Affective Bias Modification
n=22 Participants
Computer based Affective Bias Modification
Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Sham Affective Bias Modification
n=24 Participants
Computer based sham Affective Bias Modification
Sham Affective bias modification: In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
|
Assessment Only
No intervention was given, only assessments were conducted.
|
|---|---|---|---|
|
Symptom Network: Experience Sampling of Depressive Symptoms
|
.108 standardized values
Standard Deviation .785
|
-.230 standardized values
Standard Deviation .824
|
—
|
Adverse Events
Active Affective Bias Modification
Sham Affective Bias Modification
Assesment Only
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