Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

Major Depression Clinical Trial

Official title:

Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658682
• Other study ID #: NFR-229135
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Attention Bias Modification
Computer based Attention Bias Modification
• Sham Attention Bias Modification
Computer based Sham Attention Bias Modification

Locations

Country	Name	City	State
Norway	Sørlandet Hospital, Department of Psychiatry	Arendal	Aust-Agder
Norway	University of Oslo, Department of Psychology	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	Diakonhjemmet Hospital, Sorlandet Hospital HF, University of Oxford

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Automatic thoughts	Automatic Thought Questionnaire (ATQ)	At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention
Other	Changes in perceived stress	Perceived Stress Scale (PSS).	At baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after intervention
Other	Meta cognitions	Positive and Negative Beliefs about Rumination scale (PBRS and NBRS)	At baseline and 12 months after intervention
Other	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.
Other	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.
Other	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.
Other	Change in residual symptoms of depression. Self report	Beck Depression Inventory	One month after intervention, 6 months after intervention and 12 months after intervention
Other	Change in residual symptoms of depression. Clinical rating	Hamilton Depression Rating Scale	One month after intervention, 6 month after intervention and 12 month after intervention
Other	Primary outcome measures will be modified by the degree of attentional change during the ABM intervention.		Immediately after the ABM intervention
Other	Primary outcome measures will be modified by executive functioning		At baseline
Primary	Change in residual symptoms of depression. Self report.	Beck Depression Inventory	At baseline and immediately after ABM intervention (during first week after ABM).
Primary	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	Recurrence of major depressive episodes	Measured by the MINI structured interview	Will be measured 12 month after baseline
Secondary	Changes in Emotion Regulation	Emotion Regulation Questionnaire (ERQ).	At baseline.
Secondary	Changes in Rumination	The Rumination Response Scale	At baseline and 12 months after intervention
Secondary	Changes in cortisol response.	Cortisol samples from saliva measured by diural variation (6 samples).	At baseline, immediately after ABM intervention and one month after intervention.
Secondary	Changes in symptoms of anxiety	Beck Anxiety Inventory	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