A randomised controlled trial is a study in which a number of people are randomly assigned to two (or more) groups. This is done to test a specific drug, treatment or other intervention. The groups are followed up to see how effective the experimental treatment was.

According to the research published in Pilot and Feasibility Studies, a future randomised controlled trial should:

• Have an internal pilot to test the feasibility and acceptability of refined recruitment procedures
• Recruit from multiple DA agencies as well as NHS and non-NHS services
• Have an active psychological treatment in the control arm
• Use robust safety procedures
• Use clinician-administered measures for PTSD and complex post-traumatic stress disorder (CPTSD)
• One in four women have experienced DA. Women who have experienced DA are at increased risk of developing PTSD and CPTSD. Researchers from the coMforT study worked with a group of women who have experienced DA to adapt a standard mindfulness course for depression to their needs.

The study team also reviewed previously published literature and interviewed seven women and 13 professionals with experience of psychological treatments for trauma. The findings informed the development of a trauma-specific recruitment and follow-up protocol for a randomised controlled trial and further adaptations of the trauma-specific mindfulness course.

The team then tested the recruitment and follow-up procedures and refined the mindfulness course during a small pilot randomised controlled trial with 20 women with PTSD/CPTSD and a history of DA. An advisory group of women with experience of DA worked alongside researchers to ensure that the mindfulness course and trial protocol were acceptable and safe for patients with PTSD/CPTSD and a history of DA.

Working in this way meant that researchers were able to establish it would be possible to:

• Recruit and retain women with PTSD/CPTSD and a history of DA for a large-scale trial
• Deliver the trauma-specific mindfulness course during the trial
• Collect data from trial participants.
• Proving the feasibility of a large-scale trial is important. It gives confidence that investing in a full trial is worthwhile and that it would provide robust evidence as to whether a trauma-specific mindfulness course could be an effective treatment of choice.

Dr Natalia Lewis, Senior Research Fellow at the Centre for Academic Primary Care (CAPC), University of Bristol and lead author, said: “The coMforT study demonstrated that if a trauma-specific trial protocol and adaptation of a psychological treatment are co-developed with people with lived experience of trauma, it is likely to be acceptable to the target group and feasible to test in a large-scale randomised controlled trial. The next step is to secure funding for the large-scale trial, which could see results that directly improve the care of affected women.”

Gene Feder, Professor of Primary Care at CAPC, said: “We don’t know how best to reduce the disabling symptoms of PTSD experienced by many survivors of domestic abuse; mindfulness-based cognitive therapy may be effective. The coMforT pilot shows it is feasible to conduct a full trial to test effectiveness, producing evidence that commissioners need to decide whether this therapy should be available on the NHS.”