This randomized, controlled study demonstrates that use of the TIVR is associated with decreases in ratings of pain, improved coping and decreased likelihood of relapse into pain behavior. Our findings support the use of TIVR as an option for self-directed treatment as an adjunct to behavioral group therapy in order to sustain patients with chronic musculoskeletal pain.
Using the TIVR for four months post-group CBT resulted in improvements not only in measures of pain, mental health and coping but also in physical activity and performance as measured by the SF36 Physical Composite Score. The TIVR prevented relapse not only while patients used the tool but treatment gains were maintained or improved further four months after access to the TIVR was terminated. This suggests two things. First, patients were able to use the TIVR to incorporate the skills they learned in group CBT into their personal lives. Second, four months of TIVR is a sufficient duration for this adaptation process to occur.
As demonstrated in previous studies short term (9–16 weeks) group CBT for chronic pain is clearly beneficial (Basler 1993
; Basler et al 1997
; Vlaeyen et al 1995
). Patients learn new coping skills, learn from the process under the guidance of a trained therapist, and with the support of other group members. However, in many cases, beneficial effects gradually decline after the groups have finished. In our experience patients appear to recognize this vulnerability and often request to continue groups or repeat the program, and at times try to arrange follow-up support groups on their own. Continuing a group program with a skilled CBT leader as a long term process is not feasible due to cost and not necessarily desirable for adaptive functioning, as patients may benefit more from becoming independent and integrating the newly acquired skills into their daily routines.
We began this research with the hope of testing a tool to prevent relapse into pain behavior by bolstering the gains made in group CBT. Results of our pilot study suggested that the TIVR might actually enable patients to continue improving with minimal professional time investment (Naylor et al 2002
). However, that study reported results only from the TIVR intervention. The current study examines TIVR effectiveness in a randomized controlled trial utilizing a larger sample. Results are similarly positive and thus replicate the earlier pilot study.
In the present study the TIVR and Control showed similar therapeutic gains from CBT. However, outcome scores were significantly improved at the end of the four-month maintenance program in the TIVR group while scores in the non-TIVR control group remained static. Even more remarkable is that the scores in the TIVR group continue to improve further four months after TIVR program was over while scores in the control sample remain unchanged, declined, or in some instances returned to baseline (Total Pain Experience and SF 36 Physical Composite Score). Since all but one of the group comparisons were significant at the final follow-up even after taking into account changes in medication dosages, we concluded that the superior outcome of the TIVR group was unlikely to be a consequence of differential use of narcotic analgesics or benzodiazepine medication. We plan to look into the medication effect in more detail in subsequent analysis.
There are several possible mechanisms of efficacy related to positive outcome among those patients using the TIVR. First, the TIVR may serve to encourage consistent use of skills learned in CBT. Included in the TIVR Daily Questionnaire (Component 1) is a listing of skills learned in CBT with a query about whether each was used that day. This serves both as a daily reminder of the skills repertoire and an implicit reminder to review or rehearse skills as necessary (Components 2 and 3, respectively). The daily questionnaire also enables the therapist to monitor skills use and remind patients about skills that are poorly utilized. During the follow-up interviews patients in the TIVR condition often reported that the monthly therapist feedback improved their motivation to practice skills daily. We speculate that more consistent skills use in vivo likely helps patients incorporate in to their own personal lives skills first presented in the more artificial context of CBT group therapy. Such incorporation along with consistent therapist encouragement could also lead to skill mastery. This could help explain the continued improvement in clinical status even after the four months of TIVR was terminated. While we do not have a systematic measure of skills use in the no-TIVR condition, we suspect that skills most important use declines over time. We are testing for a possible differential in skills use in a new, ongoing study. We believe that the reason for the positive outcome of TIVR is patients’ adaptation of skills to personal lives.
A second potential mechanism of TIVR efficacy is improved self-monitoring
skills. Self-monitoring is believed to be one of the most important components of maintenance enhancement (Marlatt & Gordon 1985
). Relapse prevention models emphasize the utility of self-monitoring in helping patients evaluate the effects of specific coping skills, identify early warning signs of setbacks in coping efforts, and become aware of both problems and successes in dealing with setbacks (Marlatt & Gordon 1985
; Keefe & Van Horn 1993
). Consistent with this literature, we believe it likely that the TIVR daily self-monitoring was one of the contributing factors in improvement of symptoms.
A third element of efficacy is the monthly therapist feedback. Component 1 of the TIVR (pain diaries) enabled the therapist to monitor daily skills use and treatment progress. The therapist could then use this information to help patients recognize, in vivo, interactions between life events, and daily fluctuations in pain and emotions in relationship to the frequency of skills practice. We found that the use of the patient’s own self-reported information also provided opportunities for the therapist to emphasize the importance of cognitive appraisal and emotion as well as the relationship of physical activity and exacerbation of pain. During the follow-up interviews patients consistently reported that the monthly therapist feedback improved their self-awareness.
There are a few limitations that must be considered in interpreting our results. First is the relatively small sample size of only 25 subjects in each group. The demographic composition is also skewed since the sample is predominantly female and there are only two minority group members. The latter is reflective of the demographic composition of the state of Vermont.
Second, we are unable to disaggregate continued therapist support from either the informational feedback or from simple attention control. We do not know what aspects of the monthly feedback are necessary for a therapeutic effect. Could simple motivational messages unrelated to the subjects’ data be as effective?
Third, there was only 4 month follow-up post TIVR so we are not able to see if the TIVR group continued to show a superior therapeutic effect or if their clinical status began to decline over time.
A current ongoing RCT addresses many of these limitations. It includes a larger study population, an attention control condition, and a 12 month post-CBT follow-up. Future research plans include an assessment of whether the monthly message can be automated and whether the TIVR could be used as a substitute for group therapy in patients without access to CBT.
In summary, to our knowledge, there is no other self-directed treatment program that has demonstrated efficacy as a tool for pain coping skills maintenance enhancement. We created the TIVR program with the hope to prevent relapse into pain behavior after the successful completion of group CBT. We were surprised to see that patients using this tool not only did not relapse but continued to improve for four months after the TIVR was completed. We believe that if our findings are replicable then using the TIVR as a coping skill consolidation and relapse prevention program could be efficacious and cost-effective addition to any health care providers.