Condition category
Mental and Behavioural Disorders
Date applied
29/02/2012
Date assigned
27/04/2012
Last edited
07/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anorexia nervosa is a serious mental health condition where a person keeps their body weight as low as possible. Individuals with anorexia nervosa have been found to have difficulties with cognitive flexibility. Cognitive flexibility is the ability to shift attention. Shifting attention allows individuals to change their thinking and/or behaviour to adapt to changes in the environment. Cognitive Remediation Therapy was designed to improve cognitive flexibility, memory and planning skills through the use of mental exercises, reflection on thinking styles and exploring new ways of thinking in everyday life. Mental exercises include tasks that involve switching attention and estimating. The aims of this study are to investigate the effectiveness and acceptability of Cognitive Remediation Therapy as a component of treatment for anorexia nervosa, and to examine whether Cognitive Remediation Therapy enhances the effectiveness of Cognitive Behavioural Therapy.

Who can participate?
Women aged between 18 and 65 with anorexia nervosa

What does the study involve?
Participants are randomly allocated to either Group 1 or Group 2. Participants in Group 1 receive 6 individual sessions of Cognitive Remediation Therapy followed by 6 individual sessions of Cognitive Behavioural Therapy. They also undergo assessments at the start of the study, after the 6 individual sessions of Cognitive Remediation Therapy, and after the 6 sessions of Cognitive Behavioural Therapy. Group 2 receive 6 individual sessions of Cognitive Behavioural Therapy. They also undergo assessments at the start of the study and after the 6 sessions of Cognitive Behavioural Therapy.

What are the possible benefits and risks of participating?
Participants may feel positive about being involved in research investigating the effectiveness of a new treatment that could benefit future patients. It is hoped that the information gathered will be of value in improving treatment for anorexia nervosa. The time required to participate in the tests may be inconvenient for some participants, but previous studies have found that participants enjoy the tests. Concentration and attention are required throughout the tests and participants’ performance could be adversely affected by fatigue. To reduce the effect of fatigue, participants are offered a break between the tests. Another identified risk is the potential distress of participants. During the tests participants are asked about their eating behaviour and their thoughts/concerns about body shape and weight. The questionnaires are widely used in research and clinical practice with eating disorder patients. There is no evidence to suggest that these tests cause distress, but it is possible that focusing on psychological difficulties may result in some participants experiencing a degree of distress. In the unlikely event that this happens, participants will be encouraged to discuss any upsetting issues with clinical staff within NHS Tayside Eating Disorders Service who are involved in their routine outpatient care. The researcher will liaise with clinical staff and rely on their judgement as to whether specific patients are too emotionally or physically frail to participate. Participation in the study will be confidential, but if there is a risk to the participant or others the researcher will inform a named clinical member of staff within NHS Tayside Eating Disorders Service. This would be discussed with the participant prior to disclosing the information. Only the researcher and her supervisor will have access to identifiable data. Data stored on a computer will be anonymised and password protected.

Where is the study run from?
NHS Tayside (UK)

When is study starting and how long is it expected to run for?
April 2012 to July 2013

Who is funding the study?
NHS Tayside and University of Edinburgh (UK)

Who is the main contact?
Moira Cook

Trial website

Contact information

Type

Scientific

Primary contact

Ms Moira Cook

ORCID ID

Contact details

Department of Clinical Neuropsychology
South Block
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of cognitive remediation therapy as a component of treatment for anorexia nervosa: a randomised controlled trial

Acronym

Study hypothesis

Cognitive remediation therapy will increase the effectiveness of cognitive behavioural therapy

Ethics approval

Not provided at time of registration

Study design

Single-site randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anorexia nervosa

Intervention

Group 1 will receive 6 sessions of Cognitive Remediation Therapy (CRT) followed by 6 sessions of Cognitive Behavioural Therapy (CBT).
Group 2 will receive 6 sessions of CBT. Both CRT and CBT interventions will consist of individual 1 hour sessions on a weekly or maximum fortnightly basis.

CRT consists of cognitive tasks aimed at increasing the flexibility of thinking skills, improving holistic thinking skills, reflection of thinking skills and information processing. Each session will be made up of a number of tasks consisting of the following:
1. Stroop tasks
2. Estimation task
3. Card stack task
4. Switching time zones task
5. Switch-attention task
6. Maps task
7. Prioritising task
8. Up and Down task
9. How To task
10. Search and Count task
11. Main ideas task

CBT consists of making the connections between thinking, emotion, behaviour and physiology explicit to individuals through the use of behavioural experiments and guided discovery. The sessions will cover the following topics:
1. Providing education about, and explaining the multiple functions of, anorexic symptomatology
2. Presenting the cognitive rationale for treatment
3. Explaining the rationale and providing advice for restoring normal nutrition and weight
4. Prescribing normalised eating patterns
5. Implementing self-monitoring and meal planning
6. Strategies for interrupting bingeing, purgative and over-exercising behaviours as appropriate
7. Increasing motivation for change
8. Identifying dysfunctional thinking patterns
9. Developing cognitive restructuring skills
10. Modifying concepts of the self
11. Challenging cultural values regarding weight and shape
12. Summarising progress and areas of continued vulnerability
13. Reviewing warning signs of relapse
14. Reviewing fundamentals of continued progress

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Eating Disorders Examination Questionnaire (EDE-Q) (Fairburn & Cooper, 1993)

Secondary outcome measures

1. Wisconsin Card Sorting Test (Heaton, 1981)
2. National Adult Reading Test (NART) (Nelson, 1982)
3. Hayling Sentence Completion Test (Burgess & Shallice, 1997)
4. Brixton Spatial Anticipation Test (Burgess & Shallice, 1997)
5. Delis-Kaplan Executive Function System (Delis, Kaplan & Kramer, 2001)
6. Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983)
7. Social Problem Solving Inventory Revised (SPSI-R) (D'Zurilla, Nezu & Maydeu-Olivares, 1999)
8. Obsessive Compulsive Inventory (Foa, Kozak, Salkovskis, Coles & Amir, 1998)
9. Perfectionism, Perseveration and Persistence Questionnaire (Serpell, Waller, Fearon & Meyer, 2009)

Overall trial start date

01/04/2012

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female, aged 18-65
2. English as first language
3. Meet International Classification of Diseases, Tenth Revision (ICD-10) criteria for a diagnosis of anorexia nervosa or atypical anorexia nervosa
4. Receiving outpatient treatment within NHS Tayside Eating Disorders Service

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Deemed by clinical staff to be too emotionally or physically frail to participate
2. Current psychosis
3. History of Learning Disability/Developmental Disorder
4. History of head injury involving loss of consciousness
5. History/current neurological disorder
6. Uncorrected significant visual or motor impairment
7. Current/previous substance misuse
8. Administrated neuropsychological measures in the past - knowledge of neuropsychological measures

Recruitment start date

01/04/2012

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

NHS Tayside Health Board (UK)

Sponsor details

c/o Dr Vera Nuritova
Ninewells Hospital and Medical School
Tayside Medical Science Centre Research and Development Office
Residency Block
Level 3
George Pirie Way
Dundee
DD9 1SY
United Kingdom

Sponsor type

Government

Website

http://www.nhstayside.scot.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Tayside (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Edinburgh (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/04/2016: Plain English summary added.