Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.
Study Goal
The researchers aimed to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to evaluate the feasibility of conducting a definitive randomized controlled trial.
Results Summary
The study found that a brief mindfulness intervention may help reduce perceived distress and pain while increasing relaxation in chronic pain patients. Feasibility for a larger trial was assessed through adherence, patient experience, and resource allocation.
Population
Chronic pain patients attending hospital outpatient clinics.
Effective Dosage
15-minute mindfulness audios (frequency not specified).
Duration
Immediate effects assessed post-intervention; follow-ups at one week and one month.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
brief self-help mindfulness intervention | neutral | coping with chronic pain | chronic pain patients | - | assess the immediate effects | #1 |
brief mindfulness intervention | neutral | immediate effects | chronic pain patients | - | assessed | #2 |
mindfulness audios | neutral | - | treatment group | - | receives | #3 |
brief mindfulness-based intervention | decrease | perceived distress | chronic pain patients | - | effective for immediately reducing | #4 |
brief mindfulness-based intervention | decrease | pain | chronic pain patients | - | effective for immediately reducing | #5 |
brief mindfulness-based intervention | increase | relaxation | chronic pain patients | - | increasing | #6 |
BACKGROUND: The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. METHODS/DESIGN: A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. DISCUSSION: This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016. TRIAL REGISTRATION: ISRCTN61538090 Registered 20 April 2015.