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Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

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ClinicalTrials.gov Identifier: NCT03625206
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
Banaras Hindu University
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Jennifer Lau, Institute of Psychiatry, London

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.

Condition or disease Intervention/treatment Phase
Child Abuse Child Neglect Victimization Behavioral: Cognitive bias modification training Behavioral: Control training Not Applicable

Detailed Description:

Up to 160 adolescents aged 12-18 years who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) from the United Kingdom (UK), 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : May 17, 2019
Estimated Study Completion Date : July 17, 2019

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625206


Locations
India
Psychology Department Not yet recruiting
Varanasi, India
Contact: Rakesh Pandey, PhD       rpan_in@yahoo.com   
Sub-Investigator: Tushar Singh, PhD         
Sub-Investigator: Yogesh Arya, PhD         
Nepal
Psychology Department, Tribuwan University Not yet recruiting
Kathmandu, Nepal
Contact: Shanta Niraula, PhD         
United Kingdom
Psychology Department, Institute of Psychiatry, Psychology and Neuroscience Recruiting
London, United Kingdom, SE58AF
Contact: Jennifer Lau, PhD    020 7848 0678    jennifer.lau@kcl.ac.uk   
Sub-Investigator: Veena Kumari, PhD         
Sponsors and Collaborators
Institute of Psychiatry, London
Banaras Hindu University
Tribhuvan University, Nepal

Responsible Party: Jennifer Lau, Principal Investigator, Institute of Psychiatry, London
ClinicalTrials.gov Identifier: NCT03625206     History of Changes
Other Study ID Numbers: PAHBABR
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Only once data collection, analysis and dissemination is completed

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No