Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

• ClinicalTrials.gov Identifier: NCT03625206
• Recruitment Status: Recruiting
• First Posted: August 10, 2018
• Last Update Posted: August 9, 2019
• Sponsor: Institute of Psychiatry, London
• Collaborators: Banaras Hindu University; Tribhuvan University, Nepal
• Information provided by (Responsible Party): Jennifer Lau, Institute of Psychiatry, London

Study Description

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 Design

• 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, 2020
• Estimated Study Completion Date: May 17, 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• 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
• Last Update Posted: August 9, 2019
• Last Verified: August 2019

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