A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination

NCT04137367 | Completed Results

• 1 other identifier: 2019/FO249225
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Rumination; Attention bias modification; Transdiagnostic

Outcome Measures

Primary Outcomes (3)

• Self-reported Depressive Symptoms: Becks Depression Inventory-II

  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.

  At 6 months follow-up

• State Rumination: Brief State Rumination Inventory (BSRI)

  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.

  At baseline and two weeks follow up.

• State Rumination: Brief State Rumination Inventory

  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.

  At two weeks follow up.

Secondary Outcomes (3)

• Affective Bias: Dot-probe Task

  From baseline to two weeks follow up

• Symptom Network Change: Experience Sampling of Depressive Symptoms

  From two weeks prior to baseline to two weeks after the two-week intervention.

• Symptom Network: Experience Sampling of Depressive Symptoms

  Two weeks after the two-week intervention.

Study Arms (3)

Active Affective Bias Modification

EXPERIMENTAL

Computer based Affective Bias Modification

Behavioral: Affective bias modification

Sham Affective Bias Modification

SHAM COMPARATOR

Computer based sham Affective Bias Modification

Behavioral: Sham Affective bias modification

Assesment only

NO INTERVENTION

Only assessments are conducted

Interventions

Affective bias modification BEHAVIORAL

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.

Also known as: Attention Bias Modification

Active Affective Bias Modification

Sham Affective bias modification BEHAVIORAL

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.

Also known as: Sham Attention bias modification

Sham Affective Bias Modification

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder

You may not qualify if:

• Neurological disorder, mania, and/or psychosis.

Sponsors & Collaborators

• University of Oslo: lead
• Extrastiftelsen: collaborator
• Diakonhjemmet Hospital: collaborator
• University of Oxford: collaborator

Study Sites (1)

Department of Psychology

Oslo, 0317, Norway

Location

Related Publications (2)

• Bo R, Kraft B, Joormann J, Jonassen R, Harmer CJ, Landro NI. Cognitive predictors of stress-induced mood malleability in depression. Anxiety Stress Coping. 2024 Mar;37(2):278-292. doi: 10.1080/10615806.2023.2255531. Epub 2023 Sep 11.

  PMID: 37695740 DERIVED

• Bo R, Kraft B, Pedersen ML, Joormann J, Jonassen R, Osnes K, Harmer CJ, Landro NI. The effect of attention bias modification on depressive symptoms in a comorbid sample: a randomized controlled trial. Psychol Med. 2023 Oct;53(13):6389-6396. doi: 10.1017/S0033291722003956. Epub 2023 Jan 9.

  PMID: 36617964 DERIVED

Related Links

• Project web page

MeSH Terms

Conditions

Depressive Disorder, Major; Rumination Syndrome

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Results Point of Contact

• Title: Nils Inge Landrø
• Organization: University of Oslo

n.i.landro@psykologi.uio.no

+4795038479

Study Officials

• Nils Inge Landrø, Dr.Philos

  University of Oslo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 24, 2019
• Study Start: November 19, 2019
• Primary Completion: April 3, 2022
• Study Completion: April 3, 2022
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)