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CompletedNCT03625206Updated Aug 11, 2020

Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

An interventional study of Cognitive bias modification training and Control training in Child Abuse, Child Neglect and Victimization, sponsored by Institute of Psychiatry, London. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Institute of Psychiatry, London · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Child Abuse
  • Child Neglect
  • Victimization
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In context

Lead sponsor

Institute of Psychiatry, London is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Cognitive bias modification training

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

    Behavioral: Cognitive bias modification training

  • Placebo comparator
    Control training

    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

  • BehavioralCognitive bias modification training

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

  • BehavioralControl training

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after the intervention (post-intervention)

  2. 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

    Time frame: Immediately after the intervention (post-intervention)

Secondary outcomes

  1. Symptoms of emotional, behavioural and social problems

    5 subscales of the Strength and Difficulties questionnaire

    Time frame: Immediately after the intervention (post-intervention)

  2. Acceptability of intervention

    The investigators have developed a 19-item self-report feedback, comprising quantitative ratings and qualitative responses. Across eleven items, young people rate on a 4-point Likert scale whether they found the training useful, satisfying, engaging, realistic, whether it impacted anxiety, mood, coping strategies, and other difficulties , and whether they would feel motivated to complete the sessions, including without a researcher present. Higher scores reflect greater endorsement. Each of these items will be reported separately rather than used to create composite scores. There are also 8 open ended questions for young people to leave their feedback on aspects they found helpful, unhelpful, liked, disliked, improvements they would want, and other general comments.

    Time frame: Immediately after the intervention (post-intervention)

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

    P1, N1, P2, N2, P3 event-related potentials during face presentation

    Time frame: Immediately after the intervention (post-intervention)

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Study locations

2 sites
  • Psychology Department
    Varanasi, India
  • Psychology Department, Tribuwan University
    Kathmandu, Nepal
08

References and documents

Individual participant data

Plan to share: Yes — All data will be anonymised such that each participant will be associated with a unique identification (ID) number. These will be uploaded to data repository sites once data collection, analysis and dissemination is completed

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03625206
Lead sponsor
Institute of Psychiatry, London
Collaborators
Banaras Hindu University, Tribhuvan University, Nepal
Responsible party
Jennifer Lau (Principal Investigator, Institute of Psychiatry, London) — Principal investigator
First posted
Aug 10, 2018
Start date
Apr 17, 2018
Primary completion
May 17, 2020
Completion
May 17, 2020
Last update
Aug 11, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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