Condition category
Nervous System Diseases
Date applied
27/05/2009
Date assigned
21/07/2009
Last edited
15/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Brown

ORCID ID

Contact details

King's College London
Institute of Psychiatry
Department of Psychology (PO77)
De Crespigny Park
London
SE5 8AF
United Kingdom

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 measures

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

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

http://www.kcl.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/07/2016: No publications found, verifying study status with principal investigator.