Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

NCT02658682 | Completed

• 1 other identifier: NFR-229135
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. High recurrence rate suggests that there are specific vulnerability factors that increase people's risk for developing repeated episodes of the disorder. Preventive strategies should identify and ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased attention for emotional stimuli is central to the cognitive model where increased sensitivity to negative cues is believed to fuel the negative thoughts and feelings in depression and play a key role in maintaining the illness. Selective biases in attention can be modified by a simple computerized technique; The Attention Bias Modification Task (ABM). This project aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a large group highly vulnerable to depressive episodes. The effects of ABM, immediately after the two weeks intervention, on three key risk factors for depression will be studied: Residual symptoms, cortisol awakening response and emotion regulation strategies. The participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months in this group in a manner predicted by early changes in these risk factors will be investigated. It will also be tested if such effects in the lab may be dependent on candidate genes which affect serotonin reuptake and which have been implicated in malleability and emotional learning. Effects on underlying neural correlates of emotion regulation will be studied in an fMRI experiment in a sub-sample and which will also be stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of meta cognitions related to rumination and the possible mediating effects of automatic thoughts and perceived stress will also be investigated in a sub group (see also NCT02648165). The characterization of the cognitive, genetic and neural mechanisms underlying the ABM effect will have key implications for future treatment development and combination with other treatment modalities like pharmacotherapy.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (2)

• Change in residual symptoms of depression. Self report.

  Beck Depression Inventory

  At baseline and immediately after ABM intervention (during first week after ABM).

• Change in residual symptoms of depression. Clinician rating

  Hamilton Depression Rating Scale

  At baseline and immediately after ABM intervention (during first week after ABM).

Secondary Outcomes (5)

• Recurrence of major depressive episodes

  Will be measured 12 month after baseline

• Changes in Emotion Regulation

  At baseline.

• Changes in Rumination

  At baseline and 12 months after intervention

• Changes in cortisol response.

  At baseline, immediately after ABM intervention and one month after intervention.

• Changes in symptoms of anxiety

  At baseline, immediately after ABM intervention (during first week after ABM intervention), 1 month after intervention, 6 months after intervention and 12 months after intervention

Other Outcomes (10)

• Automatic thoughts

  At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention

• Changes in perceived stress

  At baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after intervention

• Meta cognitions

  At baseline and 12 months after intervention

Study Arms (2)

ABM +

EXPERIMENTAL

Attention Bias Modification

Behavioral: Attention Bias Modification

ABM -

SHAM COMPARATOR

Sham Attention Bias Modification

Behavioral: Sham Attention Bias Modification

Interventions

Attention Bias Modification BEHAVIORAL

Computer based Attention Bias Modification

ABM +

Sham Attention Bias Modification BEHAVIORAL

Computer based Sham Attention Bias Modification

ABM -

Eligibility Criteria

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

You may qualify if:

• Nondepressed subjects (based on the MINI structured interview) with a history of major depression

You may not qualify if:

• Current or past neurological illness, bipolar disorder, psychosis or drug addiction.

Sponsors & Collaborators

• University of Oslo: lead
• University of Oxford: collaborator
• Sorlandet Hospital HF: collaborator
• Diakonhjemmet Hospital: collaborator

Study Sites (2)

Sørlandet Hospital, Department of Psychiatry

Arendal, Aust-Agder, 4801, Norway

Location

University of Oslo, Department of Psychology

Oslo, 0317, Norway

Location

Related Publications (4)

• Bo R, Kraft B, Skilbrei A, Jonassen R, Harmer CJ, Landro NI. Inhibition moderates the effect of attentional bias modification for reducing residual depressive symptoms: A randomized sham-controlled clinical trial. J Behav Ther Exp Psychiatry. 2024 Dec;85:101982. doi: 10.1016/j.jbtep.2024.101982. Epub 2024 Aug 2.

  PMID: 39111231 DERIVED

• Bo R, Kraft B, Jonassen R, Pedersen ML, Harmer CJ, Landro NI. The long-term effects of ABM on symptom severity in patients with recurrent depression: A randomized sham-controlled trial. J Affect Disord. 2023 Nov 1;340:886-892. doi: 10.1016/j.jad.2023.08.024. Epub 2023 Aug 12.

  PMID: 37579884 DERIVED

• Bo R, Kraft B, Jonassen R, Harmer CJ, Hilland E, Stiles TC, Haaland VO, Aspesletten MEB, Sletvold H, Landro NI. Symptom severity moderates the outcome of attention bias modification for depression: An exploratory study. J Psychiatr Res. 2021 Jun;138:528-534. doi: 10.1016/j.jpsychires.2021.04.027. Epub 2021 May 5.

  PMID: 33984807 DERIVED

• Jonassen R, Harmer CJ, Hilland E, Maglanoc LA, Kraft B, Browning M, Stiles TC, Haaland VO, Berge T, Landro NI. Effects of Attentional Bias Modification on residual symptoms in depression: a randomized controlled trial. BMC Psychiatry. 2019 May 8;19(1):141. doi: 10.1186/s12888-019-2105-8.

  PMID: 31068158 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Nils I Landrø, Dr. Phil

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: January 20, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

NO (2)