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A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
NA trial testing Affective bias modification in Major Depressive Disorder in 108 participants. Completed in 3 April 2022.
| Lead sponsor | University of Oslo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 19 November 2019 |
| Primary completion | 3 April 2022 |
| Estimated completion | 3 April 2022 |
| Sites | 1 location across Norway |
University of Oslo
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Active Affective Bias Modification | 19.1 | ± 1.7 |
| Sham Affective Bias Modification | 16.5 | ± 1.6 |
| Assessment Only | 5.3 | ± 5.5 |
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 fo
| Group | Value | 95% CI |
|---|---|---|
| Active Affective Bias Modification | -.7 | ± 13.3 |
| Sham Affective Bias Modification | -5.8 | ± 19.1 |
| Assesment Only | -.8 | ± 7.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Active Affective Bias Modification | 34.2 | ± 15.8 |
| Sham Affective Bias Modification | 32.3 | ± 15.8 |
| Assessment Only | 23.4 | ± 20.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Active Affective Bias Modification | 18.0 | ± 28.4 |
| Sham Affective Bias Modification | 9.4 | ± 40.3 |
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 bef
| Group | Value | 95% CI |
|---|---|---|
| Active Affective Bias Modification | .0175 | ± .0819 |
| Sham Affective Bias Modification | -.685 | ± .789 |
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 rumina
| Group | Value | 95% CI |
|---|---|---|
| Active Affective Bias Modification | .108 | ± .785 |
| Sham Affective Bias Modification | -.230 | ± .824 |
This study evaluates the effect of a computerized intervention for depressive symptoms called Affective Bias Modification (ABM). A third of the patients will receive active ABM, a third will receive sham ABM and a third will undergo assessment only. The study will investigate if rumination mediates the effect of the intervention and investigate if specific symptom profiles affect the effect of the intervention.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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