N-of-1 Hub is excited to be working with the Department of Psychology at the University of Southern Denmark on a study aiming to help people with chronic whiplash associated disorders (WAD) be actively engaged and participating in their lives despite the restrictions they face in their function. The study investigates whether an adapted interdisciplinary value-based cognitive behavioral therapy (V-CBT) 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. They are associated with long-term disability, less independence, higher risk of unemployment, lower quality of life, and more. Previous research has identified a small subgroup of people around 15-20% showing high degrees of pain and disability shortly after their injury who 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 people. Instead, there is a greater need for focusing on what WHO 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, an interdisciplinary approach is needed in the more chronic cases. Psychological interventions that focus on acceptance, values, and re-orientation in life should be an active element included in the rehabilitation package alongside physical exercise/therapy.
What are Multiple Baseline Designs?
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 using repeated measurements, and analysis using visual methods and specific statistics. The multiple baseline design is useful for interventions that are irreversible (e.g., due to learning effects) and when treatment can’t be withdrawn.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). The intervention is introduced at a different time for each participant.
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 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, and a pre, post, and 3-month follow-up design."
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, Tonny Andersen, and other members of their team, including S. Ravn and O. Skov, co-designed the study with N-of-1 Hub. N-of-1 Hub held two 5-hour workshops with the team to discuss the design and analysis of a multiple baseline study. The workshop was based on our 10-step designer for single-case experimental designs, which 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 workshops helped the team to establish a rigorous protocol for a study using a multiple baseline design to test an interdisciplinary acceptance- and value-based rehabilitation approach for WAD.
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.