Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

NCT03625206 | Completed DMC

• 1 other identifier: PAHBABR
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Child Abuse; Child Neglect; Victimization

Outcome Measures

Primary Outcomes (2)

• Attention biases for threatening stimuli

  The investigators will use an experimental measure (a visual search task) that uses reaction times (RTs) to different experimental conditions to index the degree to which attention is captured by a threatening over a non-threatening stimulus.

  Immediately after the intervention (post-intervention)

• Interpretation biases for threatening explanations

  The investigators will use an experimental measure (an ambiguous scenarios task) that uses ratings to different experimental trials to index the degree to which individuals endorse threatening over benign interpretations

  Immediately after the intervention (post-intervention)

Secondary Outcomes (3)

• Symptoms of emotional, behavioural and social problems

  Immediately after the intervention (post-intervention)

• Acceptability of intervention

  Immediately after the intervention (post-intervention)

• Event related potentials to emotional face presentations during Electroencephalogram (EEG) experiment

  Immediately after the intervention (post-intervention)

Study Arms (2)

Cognitive bias modification training

EXPERIMENTAL

Participants will receive 5 training sessions, each session including attention bias modification and interpretation bias modification training modules

Behavioral: Cognitive bias modification training

Control training

PLACEBO COMPARATOR

Participants will receive 5 sessions that involve exercises that are matched to the task demands of the attention bias modification and interpretation bias modification training modules

Behavioral: Control training

Interventions

Cognitive bias modification training BEHAVIORAL

These training sessions aim to modify a selective attention bias towards threat and a tendency to interpret ambiguous situations in threatening ways

Cognitive bias modification training

Control training BEHAVIORAL

These exercises are matched to the task demands of the modules of cognitive bias modification training

Control training

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Psychiatry, London: lead
• Banaras Hindu University: collaborator
• Tribhuvan University, Nepal: collaborator

Study Sites (2)

Psychology Department

Varanasi, India

Location

Psychology Department, Tribuwan University

Kathmandu, Nepal

Location

Related Publications (1)

• Dhakal S, Gupta S, Sharma NP, Upadhyay A, Oliver A, Sumich A, Kumari V, Niraula S, Pandey R, Lau JYF. Can we challenge attention and interpretation threat biases in rescued child labourers with a history of physical abuse using a computerised cognitive training task? Data on feasibility, acceptability and target engagement. Behav Res Ther. 2023 Mar;162:104267. doi: 10.1016/j.brat.2023.104267. Epub 2023 Jan 29.

  PMID: 36780810 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are told that they will be allocated to one of two intervention conditions, one which may be more effective than the other in challenging negative thought patterns. Outcome assessors are blind to the status of the participant.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 10, 2018
• Study Start: April 17, 2018
• Primary Completion: May 17, 2020
• Study Completion: May 17, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Only once data collection, analysis and dissemination is completed

Locations

NE (1); IN (1)