NCT01652963

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

July 23, 2012

Last Update Submit

November 20, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive mediation skills

    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.

    15 minutes at baseline

Secondary Outcomes (1)

  • Emotion recognition skills

    15 minutes at baseline

Other Outcomes (1)

  • feasibility of computer-based tasks

    1 hr, baseline, intervention, post-assessment

Study Arms (2)

Control task

NO INTERVENTION

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.

Reed and Clements Training Task

EXPERIMENTAL

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

Interventions

see study arm: Reed and Clements Training Task. Training task developed to improve cognitive mediation skills in people with intellectual disabilities.

Reed and Clements Training Task

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intellectual disability

You may not qualify if:

  • Visual impairments
  • Auditory impairments
  • Currently receiving cognitive behaviour therapy
  • Acute psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NCH&C NHS Trust Learning Disability Services

Norwich, Norfolk, NR2 1AD, United Kingdom

RECRUITING

Nansa

Norwich, Norfolk, NR2 3TZ, United Kingdom

COMPLETED

Genesis - Orwell Mencap

Ipswich, Suffolk, IP3 9JG, United Kingdom

COMPLETED

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Leen Vereenooghe, BSc, MSc

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leen Vereenooghe, BSc, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 30, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations