Clinical trial NCT03625206: Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity
Official title: Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Child Neglect
Victimization
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
Collaborators: name: Banaras Hindu University
name: Tribhuvan University, Nepal
First posted: 2018-08-10
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Adolescents who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition. Outcome measures include measures of cognitive biases and symptoms of psychopathology; in addition, in a subset of adolescents, brain activity data will be acquired. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.

Detailed description: Up to 80 adolescents aged 12-18 years who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) from India and Nepal will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition over a 2-week period.

Pre and post-assessment measures include measures of attention and interpretation biases and symptoms of internalising and externalising psychopathology. In addition, in a subset of adolescents, brain activity data acquired using EEG will be acquired either during resting or viewing emotional face stimuli. Data from these measures will be used to generate effect sizes of changes for each group as well as being used in a limited number of significance-testing analysis. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.

Eligibility criteria: Inclusion Criteria:

* Adolescents aged 12-18 years
* Adolescents who have experienced adversity (abuse, neglect) or broader victimisation experiences (conventional crime)

Exclusion Criteria:

* Adolescents who have difficulty reading or understanding what is being read to them
* Adolescents who are currently at-risk for self-harm
* Adolescents who are currently experiencing psychotic symptoms
* Adolescents who are currently experiencing high-level trauma symptoms

Primary outcomes:
measure: Attention biases for threatening stimuli
timeFrame: Immediately after the intervention (post-intervention)
measure: Interpretation biases for threatening explanations
timeFrame: Immediately after the intervention (post-intervention)
Secondary outcomes:
measure: Symptoms of emotional, behavioural and social problems
timeFrame: Immediately after the intervention (post-intervention)
measure: Acceptability of intervention
timeFrame: Immediately after the intervention (post-intervention)
measure: Event related potentials to emotional face presentations during Electroencephalogram (EEG) experiment
timeFrame: Immediately after the intervention (post-intervention)
Other outcomes:
Locations:
city: Varanasi
country: India
facility: Psychology Department
city: Kathmandu
country: Nepal
facility: Psychology Department, Tribuwan University
Study officials:
References: