Picture-based Computerised Assessment and Training of Cognitive Behaviour Therapy Skills

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of East Anglia
Sponsor:
Information provided by (Responsible Party):
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01652963
First received: July 23, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

The proposed research aims to investigate whether people with intellectual disabilities are able to understand and apply the theoretical principles of cognitive behaviour therapy (CBT) regarding the interaction between events, beliefs and emotions. Two studies are designed to assess and train the ability to link events, beliefs and emotions.

Study 1 pilots computer-based tasks to assess the ability to link events, beliefs and emotions as well as a computer-based training programme aimed to link events and emotions. Task and training stimuli will be presented by line drawings to investigate whether a picture-based approach can reduce the impact of verbal ability on task performance. Training effectiveness is evaluated compared to a no-training control task.

Study 2 compares the line drawings-based approach of Study 1 to a photographic approach to investigate whether the use of photographs can increase training effectiveness and further reduce the impact of verbal ability. It is hypothesised that the high reality value of photographic task stimuli, as compared to line drawings, will have positive effects on the assessment and training of CBT skills. It is anticipated that the findings of this research will improve our ability to help people with intellectual disabilities receive CBT.


Condition Intervention
Intellectual Disabilities
Other: Reed and Clements Training Task

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Evaluating a Picture-based Computerised Assessment and Training Paradigm for Cognitive Behaviour Therapy Skills in Adults With Intellectual Disabilities

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • Cognitive mediation skills [ Time Frame: 15 minutes at baseline ] [ Designated as safety issue: No ]
    The primary outcome measure is the ability to link situations, beliefs and emotions assessed by the adapted ABC task. This task is based on the cognitive mediation task developed by Dagnan, Chadwick and Proudlove (2000). Performance on the post-intervention assessment will be compared to baseline assessment for the control group and the training group in Study 1, and for the line drawings-based and the photograph-based training group in Study 2.


Secondary Outcome Measures:
  • Emotion recognition skills [ Time Frame: 15 minutes at baseline ] [ Designated as safety issue: No ]
    Computer-based task assessing emotion recognition skills.


Other Outcome Measures:
  • feasibility of computer-based tasks [ Time Frame: 1 hr, baseline, intervention, post-assessment ] [ Designated as safety issue: No ]
    Feasibility of computer-based tasks will be measured by the type and number of assisting interventions by the researchers and the frequency of repeating the sample items of each task.


Estimated Enrollment: 132
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control task
The no-intervention control task consists of a presentation of the stimuli used in the training task. Participants will see situations and listen to the simultaneous voice recordings. Unlike in the training task participants will not receive instructions to link situations and emotions. There is no task requirement, just a presentation of the situation stimuli to assure that potential training effects are due to the training programme and not merely to the presentation of scenarios. The duration of the presentation of stimulus materials in the control group will range between fifteen and thirty minutes. The variable duration is necessary so the primary investigator cannot assume a participant's intervention group based on the duration of the intervention task.
Experimental: Reed and Clements Training Task
The training task consists of 2 blocks of 6 items with items presented randomly within each block and blocks being counterbalanced between participants. Block 1 presents a situation and prompts participants to identify whether they would feel happy or sad in the given situation. Block 2 presents an emotion (happy or sad) and prompts the participant to identify which of two situations (positive or negative) most likely preceded this emotion. Within each block there will be at least one and maximum three training rounds. The second and third training rounds will only consist of the items to which the participant responded incorrect in the previous round. Each item in rounds 2 and 3 will be followed by feedback.
Other: Reed and Clements Training Task
see study arm: Reed and Clements Training Task. Training task developed to improve cognitive mediation skills in people with intellectual disabilities.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intellectual disability

Exclusion Criteria:

  • Visual impairments
  • Auditory impairments
  • Currently receiving cognitive behaviour therapy
  • Acute psychosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652963

Contacts
Contact: Leen Vereenooghe, BSc, MSc +441603593665 L.Vereenooghe@uea.ac.uk

Locations
United Kingdom
NCH&C NHS Trust Learning Disability Services Recruiting
Norwich, Norfolk, United Kingdom, NR2 1AD
Contact: Anne-Marie Mensink, Clinical Psy    +441603 638520    anne-marie.mensink@nhs.net   
Principal Investigator: Leen Vereenooghe, Bsc, Msc         
Nansa Completed
Norwich, Norfolk, United Kingdom, NR2 3TZ
Genesis - Orwell Mencap Completed
Ipswich, Suffolk, United Kingdom, IP3 9JG
Sponsors and Collaborators
University of East Anglia
Investigators
Principal Investigator: Leen Vereenooghe, BSc, MSc University of East Anglia
  More Information

Additional Information:
No publications provided

Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT01652963     History of Changes
Other Study ID Numbers: UEA-6345832-MED1, 12/EE/0284
Study First Received: July 23, 2012
Last Updated: November 20, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014