Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01652963 |
| Other study ID # |
UEA-6345832-MED1 |
| Secondary ID |
12/EE/0284 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
July 23, 2012 |
| Last updated |
November 20, 2012 |
| Start date |
July 2012 |
| Est. completion date |
August 2013 |
Study information
| Verified date |
November 2012 |
| Source |
University of East Anglia |
| Contact |
Leen Vereenooghe, BSc, MSc |
| Phone |
+441603593665 |
| Email |
L.Vereenooghe[@]uea.ac.uk |
| Is FDA regulated |
No |
| Health authority |
United Kingdom: National Health Service |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Assessment and training tasks will all be conducted individually and they will be presented
via a computer programme on a laptop computer with an external response box (Hypothesis 2).
PROCEDURES
Pre-study procedures. When consent has been obtained, the principal investigator assesses
verbal ability (BPVS-2) and level of intellectual functioning (WASI-II). Participants who
meet the inclusion criteria will then be invited to complete the baseline assessments.
Baseline assessments. At baseline, the researcher will introduce the laptop computer and the
external response box. The computer program will be introduced and one sample item of the
assessment will be solved by the computer to illustrate how the task works. The sample item
will then be repeated for the participant to solve and for the researcher to check if the
participant understands the procedures of the task. The sample item will be repeated until
the participant understands the procedures and will have learned how to operate the response
box. The primary investigator will be present to assist the participant with the use of the
response box and to explain the task procedures.
The adapted cognitive mediation task consists of two blocks of twelve exercises. Exercises
are randomised within each block and blocks are counterbalanced between participants. Block
1 presents the six scenarios paired once with a positive and once with a negative thought
resulting in twelve task items. Each task item presents two pictures of a situation followed
by a picture of a positive or negative thought about this situation. Participants are then
prompted to identify which of two pictured emotions (happy or sad) they would feel following
the given situation and thought. Block 2 presents each scenario paired with a positive and
negative emotional response to create twelve task items. Each item presents two pictures of
a situation followed by a picture of an emotional response (happy or sad). Participants are
then prompted to identify which of two thoughts (positive or negative) is most likely to
cause the given emotion in the presented situation.
Intervention in training group. Participants will be given a break between the baseline
assessment and the intervention task. The primary investigator will be replaced by a second
researcher who will be responsible for conducting the intervention task. The intervention in
the training group is based on a task developed by Reed and Clements (1989). The training
task consists of two blocks of six items presented randomly within each block and blocks
being counterbalanced between participants. Block 1 follows the original task by presenting
a situation and prompting 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. Each block contains three positive (positive situation or happy emotion given) and
three negative items (negative situation or sad emotion given). The training task will begin
with a sample exercise solved by the computer and a sample exercise for the participant,
similarly to the procedures for the baseline assessment. Within each block there will be at
least one and maximum three training rounds. In the first training round all six items
within a block will be presented. The second and third training rounds will only consist of
the items to which the participant responded incorrect in the previous round. Each item will
now be followed by feedback and incorrect responses will be followed by the correct
response.
Intervention in control group. The intervention in the control group 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.
Post-intervention assessment. Post-intervention assessments will take place fifteen minutes
after the intervention task. The second researcher leaves the room as the primary
investigator returns to conduct the post-intervention assessments. Participants will be
reminded to not disclose any information concerning the intervention task with the
researcher. The post-intervention assessment consists of the adapted cognitive mediation
task of the baseline assessment. The same procedures of the baseline assessment apply to the
post-intervention assessment. Within each block of six exercises, four exercises will be
randomly chosen from the baseline items and two new items will be added.
STUDY 2
HYPOTHESES
1. Photographs may have an advantage over standard line drawings to improve performance on
tasks assessing the ability to link situations, beliefs and emotions. It is
hypothesised that a photographic approach will increase effectiveness of the CBT skills
training. It is assumed that the high reality value of photographs may enhance
identification with the task materials and thereby improve performance.
2. A photographic approach may, when compared to the standard verbal approach and a line
drawings-based approach, reduce the impact of verbal ability on the assessment of CBT
skills.
3. A CBT training programme aimed to link situations and emotions may improve both emotion
recognition skills and cognitive mediation skills (as assessed by the ability to link
situation, beliefs and emotions).
DESIGN
Study 2 is based on a 2 x (2 x S) mixed experimental design with a between-subjects factors
(Training group: line drawings group versus photographs group) and a within-subjects factor
(Time: baseline assessment versus post-intervention assessments).
Baseline and post-intervention assessment of CBT skills will consist of the adapted
cognitive mediation task, as it is used and described in Study 1, and of an emotion
recognition task. Both assessments will have line drawings and photographs as stimulus
materials to investigate Hypotheses 1 and 3.
The intervention in both training groups will be based on the Reed and Clements task (1989)
as described in Study 1. Participants in the line drawings group will receive the adapted
Reed and Clements task (1989) based on line drawings. Participants in the photographs group
will be presented photographs as task stimuli. The content of the task items does not differ
between the training groups, only the pictorial presentation of the items differs
(Hypothesis 1 and 2). There will be no separate control group.
PROCEDURES
Pre-study procedures. These procedures are identical to the pre-study procedures described
in Study 1.
Baseline assessments. The primary investigator will begin by reminding the participant that
their participation is voluntary, that all data will be anonymous and that they have the
right to withdraw from the study at any time. The researcher will then introduce the laptop
computer and the external response box and will continue to explain the procedures for the
task.
Baseline assessment will consist of the counterbalanced presentation of the emotion
recognition task and the adapted cognitive mediation task. The computer program will be
introduced and one sample item of the first assessment will be solved by the computer to
illustrate how the task works. The sample item will then be repeated for the participant to
solve and for the researcher to check if the participant understands the procedures of the
task. The sample item will be repeated until the participants understands the procedures and
will have learned how to operate the response box. Baseline assessment will consist of the
counterbalanced presentation of the emotion recognition task and the adapted cognitive
mediation task. For each task half of the items will be presented in line drawings and half
of the items in photographs. The procedures for the adapted cognitive mediation task have
been described in Study 1.
The emotion recognition task in Study 2 will consist of two blocks of six exercises,
counterbalanced between participants. The exercises of block 1 are based on line drawings
and the exercises of block 2 are based on photographs. All exercises, regardless of the
block condition, will begin with a three second presentation of a happy face or a sad face.
A voice recording will be played telling participants which emotion is pictured. This
presentation will be followed by a one second blank screen. Following the blank screen,
three new pictures of various emotions will be shown. A recorded voice will prompt the
participants to identify which of the three presented emotions is similar to the initially
presented emotion. The target emotions will be happy and sad, while the two distracter
emotions may vary between neutral, annoyed, disgusted, grumpy, surprised and angry.
Intervention. Participants will be given a break between the baseline assessments and the
training task. The primary investigator will leave the room and will be replaced by the
second researcher who will be responsible for conducting the training task. The training
task is the adapted Reed and Clements (1989) task based on line drawings for the line
drawings group and on photographs for the photographs group. The procedures follow the
procedure of this training task in Study 1.
Post-intervention assessments. After the training task participants will be given a short
break and the principal investigator will return to conduct the post-intervention
assessments. The researcher will remind participants to not disclose any information
regarding the training task. Post-intervention assessment of the adapted cognitive mediation
task and the emotion recognition task will follow the same procedures as for their baseline
assessment. For the post-intervention assessment half of the baseline items within each task
block will be replaced with new items to control for rehearsal effects and test for
generalisation of training effects to new items.
