Telephone-delivered cognitive behavioral therapy versus supportive care for chronic back pain: A randomized controlled trial

Clinical Research 5 min 9

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Created On: 27/02/2020

Telephone-delivered cognitive behavioral therapy versus supportive care for chronic back pain: A randomized controlled trial

Over the past decade, there is a drastically hype in the prevalence of chronic back pain (CBP) in the US population, advising a need for more treatment resources.

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Key take away

Home-based, telephone-delivered Cognitive-Behavioral Therapy (CBT) and Supportive Care (SC) treatments did not significantly differ in their benefits for back pain severity and disability, and may warrant further research for applications to hospital settings.

Background

Over the past decade, there is a drastically hype in the prevalence of chronic back pain (CBP) in the US population, advising a need for more treatment resources. Further, the most commonly used pharmacological drugs for CBP such as opioids are associated with the number of adverse events that may limit the treatment option. The use of telehealth therapy is an alternative approach for treating chronic pain. Telehealth technologies include telephone, internet-based, and smartphone applications. The number of previous reviews supported the efficacy of telehealth modalities for the management of pain, but the limited evidence is available regarding how telehealth treatments compare to traditional in-person therapies.

The present research evaluated the efficacy of telehealth adaptation of CBT for CBP in comparison to SC psychotherapy. The study hypotheses were that, relative to the SC condition, CBT treated patients would demonstrate significantly higher improvements in back pain disability (Roland Morris Disability Questionnaire), pain severity (Visual Rating Scale), and greater levels of improvement as defined by ≥25% patient-rated improvement on the Patient Clinical Global Impressions Scale.

Rationale behind the research:

The effectiveness of CBT for chronic pain has been established in prior research, but its efficacy relative to therapies that control for nonspecific factors in a telehealth format are unknown.

Therefore, Thomas Rutledge et al evaluated the efficacy of telehealth adaptation of CBT for CBP in comparison to SC psychotherapy.

Objective:

To evaluate the efficacy of a telephone-delivered, home-based cognitive-behavioral intervention for CLBP in comparison to a matched SC treatment.

Method

Study outcome measures:

Treatment Fidelity and Competence: Clinician fidelity was assessed in the CBT and SC treatments using audio tapes (with informed consent) reviewed by an independent clinician using standard psychotherapy rating forms
Treatment Satisfaction: Treatment satisfaction among participants was measured using the Client Satisfaction Questionnaire-Revised, 17 an 8-item questionnaire measuring satisfaction with health care treatment on a 4-point Likert scale (1=quite dissatisfied; 4=very satisfied)
Roland-Morris Disability Questionnaire (RMDQ): A 24-item measure assessing pain interference with everyday function with demonstrated validity and responsiveness to change
Numerical Rating Scale: A consensus measure of pain intensity measured on an 11-point scale (i.e., 0=No Pain, 10=Pain as bad as you can imagine in reference to their average pain during the previous week)
Clinical Global Impressions Scale (CGI): It is a self-rated outcome, based on the patient’s overall assessment of change in terms of pain intensity and its impact on everyday function
The study protocol also included supplementary measures of depression, anxiety, and quality of life

Time period: Baseline, and 8 weeks

Result

Figure 1: Flowchart of patient enrollment patterns across screening, randomization, and treatment completion stages

Feasibility Analyses:

Participants completed >90% of planned telephone treatment sessions in both conditions. SC participants completed an average of 10.8 (0.76) out of a maximum of 11 telephone sessions, whereas CBT participants completed an average of 10.0 (2.2) of 11 sessions. The median and modal average attendance values were 11 of 11 for both conditions. Participants in the SC condition (mean= 3.2 [0.60]) reported treatment satisfaction levels similar to those in the CBT treatment (mean= 3.5 [0.60]); p>0.05. Among a total of 9 randomized participants that withdrew during the treatment, 6 of 9 were because of protocol violations (e.g., initiating new pain therapies) or new medical concerns; the other 3 participants dropped for unspecified reasons. Fifty of the 66 randomized participants completed the 8-week treatment (75.7% overall completion rate; 66.7% completion among CBT participants versus 84.8% completion among SC participants; p>0.10 for difference). There were no differences between the completers and non-completers of the treatment on demographic characteristics or RMDQ/NRS scores (all p>0.05).

Intent-to-treat Analyses:

Although participants in both treatment groups showed within group statistically significant pre-treatment to post-treatment improvements, there were no significant between group differences on these measures. Effect sizes (Cohen d values) for both groups were in the moderate range. Differences in self-rated improvement on the CGI were also non-significant (p>0.10).

Conclusion

In this clinical trial of patients with CBP receiving 1 of 2 telephone-adapted forms of psychotherapy treatment showed treatment satisfaction and patient improvements as compared to patients receiving a parallel SC treatment. In both conditions, the significant reductions in back pain disability and pain severity were observed. The results of the current study also support the feasibility and potential efficacy of phone-adapted psychotherapy treatments among patients with CBP, and encourage further research.

The current study included the participants with acute LBP, and they received a CBT treatment. The telephone methods used in the present study was designed to evaluate the CBT treatment in a modality reflecting current treatment trends towards technology-based interventions. As summarized in recent reviews of telehealth interventions for pain telephone therapies such as those employed here are just one of a growing number of evolving smartphone, video-based, and internet and social media modalities. In contrast, the present study, unlike some other recent telehealth trials did not contain an in-person CBT or SC arm against which to compare the interventions or incorporate technologies such as smartphones, health sensors, or internet-based applications popular in current mobile health research.

There are a handful of clinical trials using psychotherapies to date targeting populations with CBP using a telephone treatment format against which to compare our population and findings. For example, relative to a 2014 telecare intervention for chronic pain in primary care trial, the baseline pain severity and reductions in pain severity we observed in response to treatment were similar (mean 5.3/10 to 4.5/10 after 3mo7 vs. a mean of 5.3/10 to 4.1/10 in the current study). Similarly, the baseline severity of pain disability measured by the RMDQ was comparable to normative data CLBP populations (mean of 12.1 and SD of 4-7-6.2, vs. a baseline mean and SD of 10.2 [4.5] in the current study) published by the instrument authors. Finally, in a 2012 trial of telephone-adapted

CBT26 that targeted patients with widespread chronic pain (fibromyalgia), the authors reported significantly better treatment outcomes relative to treatment as usual control group at the end of treatment and 3 months’ post-treatment. The latter study also included a third group, exercise treatment condition, involving an in-person orientation with a personal trainer and monthly in-person follow-up visits with the trainer to reinforce progress, observing similar improvements in the telephone CBT treatment and exercise program. Combining this latter trial and the present study results, there is accumulating data to suggest that telephone forms of CBT and SC therapy are effective and well tolerated by patients for a range of chronic pain diagnoses.

The CBP patients receiving a telephone-delivered form of CBT showed significant improvement in back pain disability, pain severity, and self-rated improvement as compared to SC treatment. Both treatments were well-tolerated, with active participation and treatment satisfaction ratings.

Limitations

The study fell substantially short of its targeted sample size of N= 130, limiting statistical power to detect hypothesized group differences
This study targeted patients with chronic pain without severe psychiatric or psychosocial impairments for whom our low intensiveness treatment was not perceived as appropriate
The study did not employ a usual care condition because our aim was to determine if CBT was superior to a supportive, non-directive approach in a telephone format
The absence of a no treatment reference group made it more difficult to establish the overall efficacy of the CBT and SC conditions as back pain can sometimes show improvement even without an active intervention

Clinical take-away

This home-based, telephone-delivered CBT and SC treatments did not significantly differ in their benefits for back pain severity and disability, and may warrant further research for applications to hospital settings.