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临床试验/NCT01652963
NCT01652963Unknown不适用

Evaluating a Picture-based Computerised Assessment and Training Paradigm for Cognitive Behaviour Therapy Skills in Adults With Intellectual Disabilities

University of East Anglia3 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
132
试验地点
3
主要终点
Cognitive mediation skills

研究概览

简要总结

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.

详细描述

STUDY 1

HYPOTHESES

  1. A picture-based training programme aimed to link situations and emotions improves the cognitive behaviour therapy (CBT) skill of linking situations, beliefs and emotions.
  2. People with intellectual disabilities can understand and follow the procedures for computer based assessment and training tasks.

DESIGN A 2 x (2 x S) mixed experimental design will be used with a between-subjects factor (Intervention: training group versus control group) and a within-subjects factor (Time: baseline assessment versus post-intervention assessment). Baseline and post-intervention assessment of CBT skills will be derived from the cognitive mediation task developed by Dagnan et al. (2000). Performance on the post-intervention assessment is considered the primary outcome variable of the study (Hypothesis 1).

The intervention in the training group will be based on the Reed and Clements task (1989) which assesses the ability to link situations and emotions. The intervention in the control group will consist of the presentation of the same stimulus materials as the intervention group. The materials will be presented without specific training instructions and matched in time with the duration of the training group intervention. The control group intervention allows for an evaluation of training task efficacy rather than evaluating the confounding effects of presenting certain stimulus materials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Intellectual disability

排除标准

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

研究组 & 干预措施

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.

干预措施: Reed and Clements Training Task (Other)

结局指标

主要结局

Cognitive mediation skills

时间窗: 15 minutes at baseline

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.

次要结局

  • Emotion recognition skills(15 minutes at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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