Carer Stress SyndromeNCT03077971
Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis
A study testing ACT Self-Help and ACT Self-Help with Telephone Support in people with Carer Stress Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carer Stress Syndrome
- What is being tested?
- ACT Self-Help and ACT Self-Help with Telephone Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary carer for a person with MS,
- English speaking (intervention and assessments are in English),
- able to give informed consent.
- score at least 21 on the Zarit Burden Interview (demonstrating a minimum of mild distress)
Who cannot join
- diagnosis of MS themselves
- psychiatric diagnosis
- inability to commit to the intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG81BB
About this study
Official title: Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial
This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in a self-help format. Participants will learn about and use ACT by reading a book provided to them by the study. One group will receive the ACT book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. Participants are allocated to the groups based on chance (a computer will decide group allocation). Participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. Those who receive the self-help book will get sent chapters each week for 8 weeks. The groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.
- Conditions
- Carer Stress Syndrome
- Being tested
- ACT Self-Help, ACT Self-Help with Telephone Support
- Keywords
- Carers of People with Multiple Sclerosis, Carer Strain, Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Self-HelpBehavioural
Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach
ACT Self-Help with Telephone SupportBehavioural
Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls
| Study group | Role | What they receive |
|---|---|---|
| ACT Self-Help | Experimental | Participants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks. Receives: Behavioral: ACT Self-Help |
| ACT Self-Help with Telephone Support | Experimental | Participants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks. In addition to this, participants will have weekly telephone calls to support the use of the book. Receives: Behavioral: ACT Self-Help with Telephone Support |
| Treatment As Usual | No intervention | Participants in this arm will have no intervention as part of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ZBI
Zarit Burden Interview as a measure of carer strain
Measured: 3 months
Secondary outcomes (6)
ZBI
Zarit Burden Interview as a measure of carer strain
Measured: 6 months
MCSI
Modified Carer Strain Index as a measure of carer strain
Measured: 3 months, 6 months
CAREQOL-MS
CAREQOL- MS is a health-related quality of life scale designed for carers of people with MS
Measured: 3 months, 6 months
AAQ-II
The Acceptance and Action Questionnaire is a measure of experiential avoidance and psychological inflexibility, consistent with the ACT model
Measured: 3 months, 6 months
CompACT
The Comprehensive Assessment of Acceptance and Commitment Therapy measures important processes of ACT
Measured: 3 months, 6 months
Service Use Questionnaire
The service use questionnaire will measure the frequency in which participants access health and social care services
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Dec 2016
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carer Stress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roshan dasNair, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077971
- Sponsor's protocol ID
- G14112016
- Status last verified
- Nov 2017
- First submitted
- 28 Feb 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Potter KJ, Golijana-Moghaddam N, Evangelou N, Mhizha-Murira JR, das Nair R. Self-help Acceptance and Commitment Therapy for Carers of People with Multiple Sclerosis: A Feasibility Randomised Controlled Trial. J Clin Psychol Med Settings. 2021 Jun;28(2):279-294. doi: 10.1007/s10880-020-09711-x.
PubMed 32144616
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03077971
- Acronym / sponsor ID
- G14112016
- Conditions
- Carer Stress Syndrome
- Keywords
- Carers of People with Multiple Sclerosis, Carer Strain, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in a self-help format. Participants will learn about and use ACT by reading a book provided to them by the study. One group will receive the ACT book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. Participants are allocated to the groups based on chance (a computer will decide group allocation). Participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. Those who receive the self-help book will get sent chapters each week for 8 weeks. The groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACT Self-Help | Experimental | Behavioral: ACT Self-HelpParticipants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks. |
| ACT Self-Help with Telephone Support | Experimental | Behavioral: ACT Self-Help with Telephone SupportParticipants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks. In addition to this, participants will have weekly telephone calls to support the use of the book. |
| Treatment As Usual | No intervention | –Participants in this arm will have no intervention as part of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary carer for a person with MS,
- English speaking (intervention and assessments are in English),
- able to give informed consent.
- score at least 21 on the Zarit Burden Interview (demonstrating a minimum of mild distress)
Key exclusion criteria (3 listed)
- diagnosis of MS themselves
- psychiatric diagnosis
- inability to commit to the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT Self-HelpSelf-Help Intervention Workbook using an Acceptance and Commitment Therapy approach | Behavioural | ACT Self-Help |
| ACT Self-Help with Telephone SupportSelf-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls | Behavioural | ACT Self-Help with Telephone Support |
Primary outcome
ZBI
Time frame: 3 months
Zarit Burden Interview as a measure of carer strain
6 secondary outcomes
ZBI
Time frame: 6 months
MCSI
Time frame: 3 months, 6 months
CAREQOL-MS
Time frame: 3 months, 6 months
AAQ-II
Time frame: 3 months, 6 months
CompACT
Time frame: 3 months, 6 months
Service Use Questionnaire
Time frame: 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Derived from this study: PubMed 32144616Potter KJ, Golijana-Moghaddam N, Evangelou N, Mhizha-Murira JR, das Nair R. Self-help Acceptance and Commitment Therapy for Carers of People with Multiple Sclerosis: A Feasibility Randomised Controlled Trial. J Clin Psychol Med Settings. 2021 Jun;28(2):279-294. doi: 10.1007/s10880-020-09711-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshan dasNair principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Self-Help and ACT Self-Help with Telephone Support in people with Carer Stress Syndrome, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ZBI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.