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Evaluation of a novel, multicomponent anxiety management programme for people with intellectual disability: protocol for a mixed-methods, quasi-experimental feasibility study.

BMJ open
January 1, 1970
Daniel Acton et al. (7 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the feasibility of a multicomponent anxiety management program (MCAMP-ID) for reducing anxiety in people with mild/moderate intellectual disability.

Results Summary

The study focuses on feasibility outcomes (recruitment, attrition, adherence, and suitability of measures) rather than efficacy results, as it is a preliminary investigation for a future randomized controlled trial.

Population

People with mild/moderate intellectual disability in Northwest England.

Effective Dosage

10 individual sessions delivered once a week.

Duration

10-12 weeks.

Interactions

None mentioned

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
modified cognitive-behavioural therapy
decrease
anxiety
people with intellectual disability
-
some benefits
#1
mindfulness
decrease
anxiety
people with intellectual disability
-
some benefits
#2
multicomponent anxiety management programme (MCAMP-ID)
decrease
anxiety
people with a mild/moderate intellectual disability
-
reducing
#3
Abstract

INTRODUCTION: Studies have shown some benefits to single approaches to psychological therapies for the treatment of anxiety in people with intellectual disability such as modified cognitive-behavioural therapy and mindfulness. To our knowledge, no studies have used a multicomponent approach for the individual treatment of anxiety-related disorders in this population group. A co-production group of clinical experts and people with intellectual disability has created a novel multicomponent anxiety management programme (MCAMP-ID). The aims of this study are to investigate (1) the feasibility of this approach in reducing anxiety for people with a mild/moderate intellectual disability, (2) the feasibility of outcome measures and (3) the feasibility of completing a future randomised controlled trial of this programme. The data from this feasibility study will be used to inform trial design and to complete power calculation. METHODS AND ANALYSIS: Sixty people with intellectual disability will be invited to participate in the study across four intellectual disability services within one mental health trust in Northwest England. The specialist services will deliver either treatment as usual (TAU) or the novel intervention (MCAMP-ID). MCAMP-ID comprises of 10 individual sessions delivered by a member of the clinical team once a week for between 10 and 12 weeks. TAU will be based on standard treatment currently delivered to meet the person's specific needs. The outcomes of the study will be feasibility of recruitment, attrition, adherence to the programme and suitability of outcome measures. A mixed-methods approach will be used to assess outcomes. ETHICS AND DISSEMINATION: The study received approval from the Research Ethics Committee and Health Research Authority (23/EM/0044) through the Integrated Research Application System (IRAS ID: 315557) in March 2023. Participants will provide informed consent before taking part. Study findings will be presented at conferences and published within a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN16062949.

Medical Subject Headings (MeSH)
HumansFeasibility StudiesIntellectual DisabilityAnxietyAnxiety DisordersCognitive Behavioral TherapyRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy65/10
Quality75/10
0
Research Impact Scores
APT Score0.05
Weight Score1.28
Normalized Score0.61
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