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Completed

NCT Number: NCT03625206

Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

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.

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Key information

Conditions

Child Abuse Child Neglect Victimization

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychology Department, Varanasi, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Control Training

Behavioral

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

Primary outcomes

  1. Attention biases for threatening stimuli

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

    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.

  2. Interpretation biases for threatening explanations

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

    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

Secondary outcomes

  1. Symptoms of emotional, behavioural and social problems

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

    5 subscales of the Strength and Difficulties questionnaire

  2. Acceptability of intervention

    Time frame: Immediately after the intervention (post-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.

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

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

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

Sponsors and collaborators

Lead sponsor

Institute of Psychiatry, London

Other

Collaborators

  • Banaras Hindu University
  • Tribhuvan University, Nepal

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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