A nurse-led intervention to reduce dopamine dysregulation syndrome in Parkinson's disease patients and their carers

ISRCTN ISRCTN82636004
DOI https://doi.org/10.1186/ISRCTN82636004
Secondary identifying numbers J-0705
Submission date
04/08/2008
Registration date
18/09/2008
Last edited
03/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Parkinson’s disease (PD) is a long-term medical condition which is caused by the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). Dopamine dysregulation syndrome (DDS) is a rare but distressing complication of Parkinson's disease (PD). In a small minority of PD patients, the desire to take their medication becomes irresistible and leads to overuse of medication. These patients may try to obtain drugs from other sources and may show extreme reluctance to reduce medication when advised to by their doctors. This drug use is linked with a number of behavioural changes including gambling, increased and inappropriate sexual activities and other risky, anti-social behaviours (known collectively as impulse control disorders, ICD’s). ICD’s are thought to be the result of dopamine-sensitive reward pathways in the brain being activated, enforcing the inappropriate behaviours. The aim of this study is to find out whether cognitive behavioural therapy (a type of talking therapy aiming to change thought patterns and behaviours) given by nurses can be an effective treatment for PD patients with ICD’s.

Who can participate?
Adults suffering from Parkinson’s disease who are suspected of having DDS or ICD’s and their carers.

What does the study involve?
Patients are randomly allocated to one of two groups. Those in the first group take part in six fortnightly sessions of cognitive behavioural therapy (CBT) with a nurse over 12-16 weeks. The sessions are individually tailored to the patient and their current situation and aim to help patients to improve understanding of their condition, strengthening relationships between patients and their carer and learning problem-solving strategies to help them to take part in less risky behaviour. After each session, participants are given written information and homework tasks to reinforce what they have covered in the sessions. Those in the second group are placed on a waiting-list for the CBT, and have no additional treatment in the study period. At the start of the study, after the treatment (12-16 weeks) and again at 24 weeks, patients and their carers in both groups are asked to complete a number of questionnaires in order to find out if the CBT has caused any change to the patients’ behaviour.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Section of Cognitive Neuropsychiatry, Kings College London (UK)

When is the study starting and how long is it expected to run for?
January 2009 to January 2011

Who is funding the study?
The Parkinson's Disease Society (UK)

Who is the main contact?
Professor Tony David

Contact information

Prof Tony David
Scientific

Section of Cognitive Neuropsychiatry
PO Box 68, De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Study information

Study designMulticentre randomised controlled unblinded crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDevelopment and evaluation of a nurse-led intervention to reduce behavioural complications of dopamine dysregulation syndrome for Parkinson's patients and their caregivers
Study acronymICaDDS
Study objectivesThe aim of the study is to try to develop and evaluate a brief (12 - 16 week) PD nurse-led intervention with the aim of reducing the psychological and social problems caused by DDS in patients and their carers. The main outcome measure will be carer burden as rated on a standardised self-report scale and distress in relation to symptoms from a carer interview.
Ethics approval(s)The Joint South London and Maudsley and The Institute of Psychiatry NHS Research Ethics Committee, 20/02/2008, ref: 08/H0807/1
Health condition(s) or problem(s) studiedParkinson's disease
InterventionThe trial will be a psychosocial intervention versus waiting list controls.

The intervention will be a psychosocial intervention and will consist of six planned, fortnightly sessions. The sessions will take place over 12 - 16 weeks. Each session will be supported by literature and homework tasks. The precise agenda for each of the sessions will be individually tailored to the particular patient and caregiver, but will follow a common framework with the following themes:
1. Building insight and understanding
2. Interpersonal communication techniques to strengthen the patient-carer relationship
3. Problem solving and behavioural strategies for management and risk minimisation

The case manager element of the PD research nurse's role will comprise liaising between medical and social care agencies.
Intervention typeOther
Primary outcome measureAssessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks.

Caregiver:
1. The Zarit Carer Burden scale
2. The General Health Questionnaire (GHQ-12)
3. The Neuropsychiatric Inventory (given at 0 and repeated at 24 weeks)

Patients:
Individualised and standard scales to rate the frequency/severity/impact of the problem behaviour (e.g., Voon scales for gambling/hypersexuality). These will be recorded during the course of the trial as an aid to the individual intervention and to serve as a target for change (pre-treatment versus end of treatment scores).
Secondary outcome measuresAssessments will take place at randomisation (week 0), at 12 - 16 weeks (end of treatment for the treatment group) and 24 weeks.

1. Neuropsychiatric Inventory symptoms-cluster scores
2. The Golombok Rust Inventory Marital Status
3. Changes in medication, added psychotropic drugs and resource use (e.g. emergency doctor services; hospital admission)

It will not be feasible to rate outcome blind to treatment allocation since any carer interview is bound to reveal this. Observer bias will be minimised by the use of self-report measures.
Overall study start date01/01/2009
Completion date01/01/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40 from across all sites
Key inclusion criteria1. Patients and caregiver dyads, male and female aged 18 years and older
2. Participants must have clinical diagnosis of Parkinson's disease
3. Participants must be suspected of having dopamine dysregulation syndrome or impulse control disorders
4. Both members of the dyad must be able to consent to the study
Key exclusion criteria1. Participant cannot speak English
2. Participant has a Mini Mental State Examimation (MMSE) Score of less than 19
3. Participant does not have an identifiable carer
Date of first enrolment01/01/2009
Date of final enrolment01/01/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Section of Cognitive Neuropsychiatry
King's College London
Denmark Hill
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Dr Gill Dale
Research and Development Office P005
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Website http://www.iop.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

The Parkinson's Disease Society (UK) (ref: J-0705)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/02/2013 Yes No

Editorial Notes

03/02/2016: No further publications found, plain English summary added.