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Multiple Baseline Design to test an acceptance- and value-based rehabilitation approach for Whiplash

N-of-1 Hub is delighted to be working with researchers in the Department of Psychology at the University of Southern Denmark on a study aiming to help people with chronic Whiplash Associated Disorders (WAD) increase engagement and participation in their lives despite restrictions in their function. The study investigates whether an adapted interdisciplinary Value-Based Cognitive Behavioral Therapy program will increase value-based living and reduce disability in people with chronic WAD.

What is the clinical problem?

Psychological sequelae of WAD are common and associated with long-term disability, less independence, higher risk of unemployment, and lower quality of life. Previous research has identified a small subgroup of 15-20% patients who show high degrees of pain and disability shortly after their injury and experience little benefit from traditional treatment options. A wealth of research has emphasised that treating only the symptoms is not the optimal approach for this group of patients. Instead, there is a greater need for focusing on what the World Health Organization has termed “participation” in the International Classification of Functioning model. This reflects focusing on how to be actively engaged and participating in one’s life despite restrictions in one’s function.

Although physical exercise/therapy is a key part of rehabilitation for people with WAD, an interdisciplinary approach is often needed in chronic cases. Psychological rehabilitation, which focuses on acceptance, values, and re-orientation in life, should be an active element in the rehabilitation package alongside physical exercise/therapy. In this study, we aim to test an interdisciplinary acceptance- and value-based rehabilitation approach for WAD using a Multiple Baseline Design.

What is a Multiple Baseline Design?

Multiple Baseline Designs (MBD) are a type of Single-Case Experimental Design, where a single person acts as their own control to test the effect of sequential (± randomised) introduction of an intervention. It involves repeated outcome measurements and analysis using visual and statistical techniques. The Multiple Baseline Design is useful for interventions that are irreversible due to learning effects, and when treatment can’t be withdrawn. In this design, outcomes are measured across either multiple individuals, behaviours, or settings. The multiple baseline starts with the baseline (phase A), then proceeds with the intervention (phase B). Each participant is tested in an AB design, but the treatment is introduced at a different time for each participant. See the example below.

Simulated data demonstrating a multiple baseline design across three different settings. Reproduced from Tate & Perdices N-of-1 Trials in the Behavioral Sciences. In Nikles and Mitchell (Ed.), The Essential Guide to N-of-1 Trials in Health (pp19-41). Dordecht, Netherlands: Springer.

A Multiple Baseline Design to test Value-Based Cognitive Behavioral Therapy in people with chronic WAD

Assistant Professor Anders Aaby, study lead, explained: “The study aims to investigate the effectiveness of an adapted interdisciplinary Value-Based Cognitive Behavioral Therapy (V-CBT) program in reducing disability and increasing value-based living for people with chronic WAD. We are also interested in quality of life, pain acceptance, pain self-efficacy and reducing depression, anxiety, stress, pain, and worry about pain. The study will also look at the temporal relationships between disability, value-based living, pain severity, pain acceptance, worry about pain, and pain self-efficacy during the intervention. The study will be a multiple baseline Single-Case Experimental Design with participants randomised to one of three baseline periods (tiers) of 2, 3, and 4 weeks, with additional pre, post, and 3-month follow-up outcome measurements.”

Professor Tonny Andersen said: “We previously showed the V-CBT program to be effective for people with acute WAD. We now want to see if it works for chronic WAD and when provided in an interdisciplinary setting. We hope that this study will help people with chronic WAD to focus on being actively engaged and participating in their lives despite restrictions in their function.”

Anders Aaby and Tonny Andersen, along with other members of the team Sophie Ravn and Ole Skov, co-designed the study with N-of-1 Hub. Associate Professor Jane Nikles, Director of N-of-1 Hub, said: “We held two workshops with the team and discussed the details of the Multiple Baseline study design using our 10 step SCED designer. This covers each aspect of study design, including primary and secondary outcome measures, finer design points, randomisation and blinding, intervention, ethics, data analysis and more.”

The study is currently under ethical review and will commence later this year.

N-of-1 Hub is a consulting company that specialises in designing, conducting and analysing personalised clinical studies using single-case designs. N-of-1 Hub also offers data management and analysis services and customised training workshops.

For more information about N-of-1 Hub, and to discuss your study needs, please contact us.

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