Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Rehabilitation treatment and informationBehavioral: cognitive behavioural therapy (CBT)Behavioral: cognitive behaviour therapy supported by ICT
- Registration Number
- NCT01802671
- Lead Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Brief Summary
The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies
- Detailed Description
Background: Psychological treatments have been successful in the treatment of chronic low back pain (CLBP). However the effect sizes are still modest and there is room for improvement. A way to progress in this line is enhancing treatment adherence and self-management by means of information and communication technologies (ICT). The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment (CBT) group program for CLBP supported versus non-supported by ICTs. A secondary objective is to evaluate the influence of relevant variables in treatment response. Possible barriers in the implementation of CBT with and without ICT will be also investigated.
Methods: A randomized controlled trail with 180 CLBP patients recruited in specialized care will be conducted. Participants will be randomly assigned to three conditions: Control group (CG), Cognitive Behavioural program (CBT), and CBT supported by ICTs (CBT + ICT). Participants belonging to the three conditions will receive a conventional rehabilitation program (back school). The CBT group program will last six sessions. The CBT + ICT will use the Internet and SMS in order to practice the therapeutic strategies between sessions and in the follow-ups in their homes. Primary outcome variables are self-reported disability and pain intensity. Assessment will be carried out by blinded assessors in five moments: pre-treatment, post-treatment and 3-, 6-, and 12-month follow-up. The influence of catastrophizing, fear-avoidance beliefs, anxiety and depression in response to treatment in the primary outcomes will be also analysed.
Discussion This study will show data of the possible benefits of the use of ICTs in the improvement of CBT for the treatment of CLBP
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- age between 20 and 65 years
- suffering low back pain for at least 6 months
- availability of mobile phone in order to get SMS
- access to computer with Internet connection in order to be able to use the CBT program supported by ICT
- mental retardation
- not proficient in Spanish
- neurogenic claudication or neurologic deficit
- history of vertebral fracture, previous lumbar surgery
- vertebral infection
- spinal or nerve tumor
- severe mental disorder or substance abuse or dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cognitive behaviour therapy supported by ICT cognitive behavioural therapy (CBT) The patients of this group will receive the same interventions that the CBT group but will receive a reinforcements of the sessions' content through two different ways: a web tool named TEO (Emotional Therapy Online) and SMS that will send to the patients' mobile phone with reminders and reinforcements. cognitive behaviour therapy supported by ICT cognitive behaviour therapy supported by ICT The patients of this group will receive the same interventions that the CBT group but will receive a reinforcements of the sessions' content through two different ways: a web tool named TEO (Emotional Therapy Online) and SMS that will send to the patients' mobile phone with reminders and reinforcements. Rehabilitation treatment and information Rehabilitation treatment and information Patients will receive the traditional rehabilitation treatment and information cognitive behaviour therapy supported by ICT Rehabilitation treatment and information The patients of this group will receive the same interventions that the CBT group but will receive a reinforcements of the sessions' content through two different ways: a web tool named TEO (Emotional Therapy Online) and SMS that will send to the patients' mobile phone with reminders and reinforcements. cognitive behavioural therapy (CBT) Rehabilitation treatment and information Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT. cognitive behavioural therapy (CBT) cognitive behavioural therapy (CBT) Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT.
- Primary Outcome Measures
Name Time Method Change in Disability: Change in the Roland-Morris Questionnaire five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). The Roland-Morris Questionnaire is one of the most widely used measures to assess disability in patients with low back pain, and it has shown good psychometrics properties (reliability and validity). The Spanish version of the RM will be completed by the patients. This questionnaire was designed to evaluate low back pain, with 24 statements that describe different daily activities that can be affected by low back pain. The participant has to select those statements that describe the limitations produced by low back pain.
Change in Pain measured by Numerical Rating Scale (NRS) five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). Pain: IMMPACT recommends the use of Numerical Rating Scales (NRS) as a core outcome measure of efficacy in clinical trials of chronic pain treatments. The scale is composed of 11 numbers ranging from 0 to 10 with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'. Two different scales will be used, one to assess low back pain and the other one to assess sciatica pain
- Secondary Outcome Measures
Name Time Method Change in Pain coping strategies five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). Pain coping strategies: The Coping Strategies Questionnaire (CSQ) assesses the frequency of several cognitive and behavioral strategies to cope with pain. Patients must select in a Likert-type scale how often they use each strategy. It comprises seven subscales, six for cognitive strategies (ignoring pain, reinterpretation of pain, diverting attention, coping self statements, catastrophizing, praying/hoping) and one subscale for behavioural strategies (activity level). This questionnaire has been validated in the Spanish population and has shown good psychometrics properties to the evaluation of patients with chronic musculoskeletal pain.
Change in Anxiety and Depression five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). Levels of anxiety and depression will be assessed by using the HADS questionnaire (Hospital Anxiety and Depression Score). This questionnaire is widely used in clinical practice. The HADS is a fourteen item scale where seven of the items are related to anxiety and the others seven are related to depression. The Spanish version has shown good internal consistency and external validity, as well as an adequate sensitivity in order to identify clinically significant depression.
Change in Fear-Avoidance Beliefs five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). The Fear-Avoidance Beliefs Questionnaire (FABQ) will be used to measure this domain. Is a scale composed by sixteen items developed to assess patients' beliefs and attitudes about the causes and consequences of their low back pain. Participants rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree). The FABQ consists of 2 subscales. The first sub-scale is the Physical Activity subscale (FABQpa), is composed by seven items, and assesses the effects of physical activities over pain. The second subscale is the Work subscale (FABQw) composed by four items, and it assesses the way that work activities can affect pain. The Spanish version has shown excellent psychometrics properties.
Change in Catastrophizing five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). The Pain Catastrophizing Scale (PCS) assesses the tendency to consider pain as a threat with exaggerated negative consequence to the patient. It is a 13-item self-report scale, each item evaluate the pain experience, as an example: "I become afraid that the pain will get worse". Participants assess the frequency that these ideas appears, on a likert-type scale ranging from 0 to 4 being 0 "not at all" and 4 "all the time". The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. A high score on the total PCS score indicates a high level of catastrophizing. The Spanish version of PCS has demonstrated adequate psychometrics properties.
Change in Quality of life assessed by the SF-12 questionnaire five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months). The SF-12 is the brief version of the 36-item Short Form Health Survey (SF-36). The SF-12 contains items that measure each of the eight concepts included in the SF-36, namely physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). The SF-12 contains six-point scales were patients evaluated the frequency and intensity of each statement during the past month.
Trial Locations
- Locations (1)
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain