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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-support Acceptance and Commitment Therapy (ACT) | Behavioral | Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in reducing anxiety, as measured using online psycho-metrics. | Effectiveness will be assessed using quantitative measures which will be completed by participants online. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation |
| Effectiveness in reducing depression, as measured using online psycho-metrics. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls. |
| 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 |
Effectiveness will be assessed using quantitative measures which will be completed by participants online. |
| 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. | 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. | At post-intervention (12 weeks after randomisation) and 6 months after randomisation |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |