Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-01 @ 9:45 AM
Study NCT ID:
NCT02596633
Status:
UNKNOWN
Last Update Posted:
2016-02-18
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT of Telephone-supported ACT in MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of recruitment, measured with telephone-interviews.', 'timeFrame': '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', 'description': 'A sub-sample of participants will be interviewed over the phone to assess their views on their recruitment into the trial.'}, {'measure': 'Feasibility of randomisation, measured with telephone-interviews.', 'timeFrame': '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', 'description': 'A sub-sample of participants will be interviewed over the phone to assess their views on how they were randomised.'}, {'measure': 'Feasibility of psychometric assessment, measured with telephone-interviews.', 'timeFrame': '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', 'description': 'A sub-sample of participants will be interviewed over the phone to assess their views on the battery of psychometric assessments.'}, {'measure': 'Feasibility of the self-help book, measured with telephone-interviews.', 'timeFrame': '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', 'description': 'A sub-sample of participants will be interviewed over the phone to assess their views on the self-help book.'}, {'measure': 'Feasibility of the telephone-support calls, measured with telephone-interviews.', 'timeFrame': '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', 'description': 'A sub-sample of participants will be interviewed over the phone to assess their views on the telephone support calls.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness in reducing anxiety, as measured using online psycho-metrics.', 'timeFrame': 'At post-intervention (12 weeks after randomisation) and 6 months after randomisation', 'description': 'Effectiveness will be assessed using quantitative measures which will be completed by participants online.'}, {'measure': 'Effectiveness in reducing depression, as measured using online psycho-metrics.', 'timeFrame': 'At post-intervention (12 weeks after randomisation) and 6 months after randomisation', 'description': 'Effectiveness will be assessed using quantitative measures which will be completed by participants online.'}, {'measure': 'Effectiveness in reducing physical health problems, as measured using online psycho-metrics.', 'timeFrame': 'At post-intervention (12 weeks after randomisation) and 6 months after randomisation', 'description': 'Effectiveness will be assessed using quantitative measures which will be completed by participants online.'}, {'measure': 'Effectiveness in increasing quality of life, as measured using online psycho-metrics.', 'timeFrame': 'At post-intervention (12 weeks after randomisation) and 6 months after randomisation', 'description': 'Effectiveness will be assessed using quantitative measures which will be completed by participants online.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAcceptance 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.\n\nPeople 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale\n\nExclusion Criteria:\n\n* Already receiving psychotherapy'}, 'identificationModule': {'nctId': 'NCT02596633', 'briefTitle': 'A RCT of Telephone-supported ACT in MS', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'A Feasibility Randomized Control Trial (RCT) of Telephone-supported Acceptance and Commitment Therapy (ACT) for Low Mood in Multiple Sclerosis (MS)', 'orgStudyIdInfo': {'id': '14094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'Participants carry on with their usual care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'ACT self help book with telephone support calls; Telephone-support Acceptance and Commitment therapy (ACT)', 'interventionNames': ['Behavioral: Telephone-support Acceptance and Commitment Therapy (ACT)']}], 'interventions': [{'name': 'Telephone-support Acceptance and Commitment Therapy (ACT)', 'type': 'BEHAVIORAL', 'description': 'Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls', 'armGroupLabels': ['Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}