Multiple SclerosisPhase 3NCT02596633
A RCT of Telephone-supported ACT in MS
A Phase 3 study testing Telephone-support Acceptance and Commitment Therapy (ACT) in people with Multiple Sclerosis, run by University of Nottingham.
Trial summary
This study will investigate the feasibility of running a randomised controlled trial (RCT) of a psychotherapy called "Acceptance and Commitment Therapy (ACT)", delivered in a self-help format with additional telephone support from a therapist, for people with Multiple Sclerosis (MS) and low mood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Telephone-support Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2016
- Phase
- Phase 3
- 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
- Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale
Who cannot join
- Already receiving psychotherapy
About this study
Official title: A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)
This study will investigate the feasibility of running a randomised controlled trial (RCT) of a psychotherapy called "Acceptance and Commitment Therapy (ACT)", delivered in a self-help format with additional telephone support from a therapist, for people with Multiple Sclerosis (MS) and low mood.
Read the detailed description
A large proportion of people with Multiple Sclerosis (MS) suffer from emotional problems, therefore a large percentage of people with MS would be eligible to take part in a study offering a psychotherapeutic component to address these issues.
Acceptance and Commitment Therapy (ACT) has been found to be effective for mood problems, and been successfully used in self-help format, but no study has thus-far examined potential for use as an effective intervention in this (MS) population.
People will MS and low mood will be recruited from a neurology outpatient clinic. They will be randomized to either receive treatment as usual, or an ACT self-help book with 8 supportive telephone calls from a trainee clinical psychologist. Measures of anxiety, depression, quality of life and physical health will be administered at baseline, post-intervention and six month follow up. A sub sample of 10 participants will be interviewed to find out their view on taking part in the study.
- Conditions
- Multiple Sclerosis
- Being tested
- Telephone-support Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-support Acceptance and Commitment Therapy (ACT)Behavioural
Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Participants carry on with their usual care |
| Intervention | Active comparator | ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT) Receives: Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment, measured with telephone-interviews.
A sub-sample of participants will be interviewed over the phone to assess their views on their recruitment into the trial.
Measured: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
Feasibility of randomisation, measured with telephone-interviews.
A sub-sample of participants will be interviewed over the phone to assess their views on how they were randomised.
Measured: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
Feasibility of psychometric assessment, measured with telephone-interviews.
A sub-sample of participants will be interviewed over the phone to assess their views on the battery of psychometric assessments.
Measured: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
Feasibility of the self-help book, measured with telephone-interviews.
A sub-sample of participants will be interviewed over the phone to assess their views on the self-help book.
Measured: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
Feasibility of the telephone-support calls, measured with telephone-interviews.
A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls.
Measured: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
Secondary outcomes (4)
Effectiveness in reducing anxiety, as measured using online psycho-metrics.
Effectiveness will be assessed using quantitative measures which will be completed by participants online.
Measured: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in reducing depression, as measured using online psycho-metrics.
Effectiveness will be assessed using quantitative measures which will be completed by participants online.
Measured: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in reducing physical health problems, as measured using online psycho-metrics.
Effectiveness will be assessed using quantitative measures which will be completed by participants online.
Measured: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in increasing quality of life, as measured using online psycho-metrics.
Effectiveness will be assessed using quantitative measures which will be completed by participants online.
Measured: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596633
- Sponsor's protocol ID
- 14094
- Status last verified
- Feb 2016
- First submitted
- 16 Oct 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT02596633
- Acronym / sponsor ID
- 14094
- Conditions
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 4 Nov 2015 (estimated)
- 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 study will investigate the feasibility of running a randomised controlled trial (RCT) of a psychotherapy called "Acceptance and Commitment Therapy (ACT)", delivered in a self-help format with additional telephone support from a therapist, for people with Multiple Sclerosis (MS) and low mood.
Detailed description
A large proportion of people with Multiple Sclerosis (MS) suffer from emotional problems, therefore a large percentage of people with MS would be eligible to take part in a study offering a psychotherapeutic component to address these issues.
Acceptance and Commitment Therapy (ACT) has been found to be effective for mood problems, and been successfully used in self-help format, but no study has thus-far examined potential for use as an effective intervention in this (MS) population.
People will MS and low mood will be recruited from a neurology outpatient clinic. They will be randomized to either receive treatment as usual, or an ACT self-help book with 8 supportive telephone calls from a trainee clinical psychologist. Measures of anxiety, depression, quality of life and physical health will be administered at baseline, post-intervention and six month follow up. A sub sample of 10 participants will be interviewed to find out their view on taking part in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Participants carry on with their usual care |
| Intervention | Active comparator | Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT)ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale
Key exclusion criteria (1 listed)
- Already receiving psychotherapy
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 |
|---|---|---|
| Telephone-support Acceptance and Commitment Therapy (ACT)Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls | Behavioural | Intervention |
Primary outcome
Feasibility of recruitment, measured with telephone-interviews.
Time frame: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
A sub-sample of participants will be interviewed over the phone to assess their views on their recruitment into the trial.
Feasibility of randomisation, measured with telephone-interviews.
Time frame: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
A sub-sample of participants will be interviewed over the phone to assess their views on how they were randomised.
Feasibility of psychometric assessment, measured with telephone-interviews.
Time frame: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
A sub-sample of participants will be interviewed over the phone to assess their views on the battery of psychometric assessments.
Feasibility of the self-help book, measured with telephone-interviews.
Time frame: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
A sub-sample of participants will be interviewed over the phone to assess their views on the self-help book.
Feasibility of the telephone-support calls, measured with telephone-interviews.
Time frame: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm
A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls.
4 secondary outcomes
Effectiveness in reducing anxiety, as measured using online psycho-metrics.
Time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in reducing depression, as measured using online psycho-metrics.
Time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in reducing physical health problems, as measured using online psycho-metrics.
Time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Effectiveness in increasing quality of life, as measured using online psycho-metrics.
Time frame: At post-intervention (12 weeks after randomisation) and 6 months after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone-support Acceptance and Commitment Therapy (ACT) in people with Multiple Sclerosis, run by University of Nottingham.
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 1 inclusion and 1 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of recruitment, measured with telephone-interviews. (time frame: At post-intervention, which is the specific time point when participants report to the researchers that they have finished their self-help books and support calls, or exactly 12 weeks after randomisation for those in the treatment-as-usual arm). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2016.