Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

• Sponsor: University of Oslo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02658682
• Collaborator: University of Oxford (Other), Sorlandet Hospital HF (Other), Diakonhjemmet Hospital (Other)
• Enrollment: 350
• Locations: 2
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 175
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depression	Behavioral: Attention Bias Modification; Behavioral: Sham Attention Bias Modification	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABM + Attention Bias Modification	Behavioral: Attention Bias Modification; Computer based Attention Bias Modification
Sham Comparator: ABM - Sham Attention Bias Modification	Behavioral: Sham Attention Bias Modification; Computer based Sham Attention Bias Modification

Outcome Measures

Primary Outcome Measures

1. Change in residual symptoms of depression. Self report. [At baseline and immediately after ABM intervention (during first week after ABM).]

   Beck Depression Inventory

2. Change in residual symptoms of depression. Clinician rating [At baseline and immediately after ABM intervention (during first week after ABM).]

   Hamilton Depression Rating Scale

Secondary Outcome Measures

1. Recurrence of major depressive episodes [Will be measured 12 month after baseline]

   Measured by the MINI structured interview

2. Changes in Emotion Regulation [At baseline.]

   Emotion Regulation Questionnaire (ERQ).

3. Changes in Rumination [At baseline and 12 months after intervention]

   The Rumination Response Scale

4. Changes in cortisol response. [At baseline, immediately after ABM intervention and one month after intervention.]

   Cortisol samples from saliva measured by diural variation (6 samples).

5. 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]

   Beck Anxiety Inventory

Other Outcome Measures

1. Automatic thoughts [At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention]

   Automatic Thought Questionnaire (ATQ)

2. 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]

   Perceived Stress Scale (PSS).

3. Meta cognitions [At baseline and 12 months after intervention]

   Positive and Negative Beliefs about Rumination scale (PBRS and NBRS)

4. 5-HTTLPR+A>G polymorphic variation divided by the triallelic functional "high expressive" versus "low expressive" genotype will moderat the effect of ABM on residual symptoms compared to neutral ABM placebo condition [Immediately after ABM intervention.]

5. Brain Derived Neurotrophic Factor (BDNF) val66met polymorphic variation linked to Brian Derived Neurotrophic Factor (BDNF) variation will moderate the effect of ABM on residual symptoms compared to neutral ABM placebo condition [Immediately after ABM intervention.]

6. A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on residual symptoms compared to neutral placebo condition [Immediately after ABM intervention.]

7. Change in residual symptoms of depression. Self report [One month after intervention, 6 months after intervention and 12 months after intervention]

   Beck Depression Inventory

8. Change in residual symptoms of depression. Clinical rating [One month after intervention, 6 month after intervention and 12 month after intervention]

   Hamilton Depression Rating Scale

9. Primary outcome measures will be modified by the degree of attentional change during the ABM intervention. [Immediately after the ABM intervention]

10. Primary outcome measures will be modified by executive functioning [At baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sørlandet Hospital, Department of Psychiatry	Arendal	Aust-Agder	Norway	4801
2	University of Oslo, Department of Psychology	Oslo		Norway	0317

Sponsors and Collaborators

• University of Oslo
• University of Oxford
• Sorlandet Hospital HF
• Diakonhjemmet Hospital

Investigators

• Principal Investigator: Nils I Landrø, Dr. Phil, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nils Inge Landrø, Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT02658682
• Other Study ID Numbers: NFR-229135
• First Posted: Jan 20, 2016
• Last Update Posted: Apr 26, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Apr 26, 2019