Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CSA/07/017
Study information
Scientific title
Caring for carers of people with Parkinson's disease (C4C-PD): a multicentre randomised controlled trial of the development and evaluation of a nurse-led group-based psychological intervention for caregiver stress and distress
Acronym
C4C-PD
Study hypothesis
Is a psychological group intervention effective in reducing the level of stress and distress experienced by carers of patients with Parkinson's disease?
Ethics approval
Joint South London and Maudsley and Institute of Psychiatry NHS Research Ethics Committee, 05/02/2009, ref: 09/H0807/6
Study design
Interventional multicentre randomised controlled trial (delayed treatment)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Carer stress; Parkinson's disease
Intervention
1. Cognitive behavioural therapy nurse-led group intervention: 6 - 9 carers per group, 8 x 2 hour sessions at weekly intervals over 2 - 3 months. Intervention guided by trial manual and supporting materials.
2. Waiting list group: The waiting list group will be offered treatment after 3 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
28-item General Health Questionnaire (GHQ-28): score at the end of treatment for the immediate treatment group compared to score of the delayed treatment group at the same timepoint. Measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects.
Secondary outcome measures
1. Zarit Caregiver Burden Interview
2. Caregiver Strain Index
3. Geriatric Depression Scale (GDS-15)
In addition to the analysis at the primary endpoint, (uncontrolled) treatment effects at the end of follow-up relative to baseline and end of treatment will be analysed as a secondary endpoint. All measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects.
Overall trial start date
01/08/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants must:
1. Be the primary caregiver for the person with Parkinson's disease and either live in the same home and/or have at least 12 hours direct care-related contact per week
2. Be able to provide informed consent
3. Be willing and able to attend 8 weekly or fortnightly sessions
4. Score 5 or more ('case' level problems) using binary (0/1) scoring on the 28-item General Health Questionnaire (GHQ-28)
5. Be aged 18 years or older (no upper age limit), males or females
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
146
Participant exclusion criteria
Participants will be excluded if they:
1. Lack sufficient spoken language skills and literacy to meaningfully engage with the sessions or complete treatment related activities between sessions
2. Are felt unlikely to comply with the 'rules' that typically apply to participants in group-based interventions (e.g. maintaining confidentiality, allowing others to speak)
3. They have received psychological therapy or a course of counselling in the past year, are currently receiving treatment or counselling, or plan to start in the next year
Recruitment start date
01/08/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Research Governance/Clinical Trials Facilitator
R&D Office PO05
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Parkinson's Disease Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Edmund J Safra Philanthropic Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list