Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain. A randomized controlled trial of a cognitive-behavioral family intervention for pediatric recurrent abdominal pain. Parents as distraction coaches during i.v. insertion: a randomized study. Cognitive-behavioral therapy for children with functional abdominal pain and their parents decreases pain and other symptoms. Clinical hypnosis versus cognitive behavioral training for pain management with pediatric cancer patients undergoing bone marrow aspirations. Treatment of nonorganic recurrent abdominal pain: cognitive-behavioral family intervention. Cognitive-behavioral treatment of persistent functional somatic complaints and pediatric anxiety: an initial controlled trial. Management of injection pain in children. Use of distraction with children during an acute pain experience. Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. Evaluating the effectiveness of exposure and acceptance strategies to improve functioning and quality of life in longstanding pediatric pain--a randomized controlled trial. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Efficacy of cognitive-behavioral intervention for juvenile primary fibromyalgia syndrome. A family-based randomized controlled trial of pain intervention for adolescents with sickle cell disease. Cognitive behavioral therapy of socially phobic children focusing on cognition: a randomised wait-list control study. The treatment of recurrent abdominal pain in children: a controlled comparison of cognitive-behavioral family intervention and standard pediatric care. Evaluation of a cognitive-behavioural intervention for pregnant injecting drug users at risk of HIV infection. A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial.
Cognitive-behavioral therapy (CBT) interventions show promise for decreasing chronic pain in youth. However, the availability of CBT is limited by many factors including distance to major treatment centers and expense. This study evaluates a more accessible treatment approach for chronic pediatric pain using an Internet-delivered family CBT intervention. Participants included 48 children, aged 11-17 years, with chronic headache, abdominal, or musculoskeletal pain and associated functional disability, and their parents. Children were randomly assigned to a wait-list control group or an Internet treatment group. Primary treatment outcomes were pain intensity ratings (0-10 NRS) and activity limitations on the Child Activity Limitations Interview, both completed via an online daily diary. In addition to their medical care, the Internet treatment group completed 8 weeks of online modules including relaxation training, cognitive strategies, parent operant techniques, communication strategies, and sleep and activity interventions. Youth randomized to the wait-list control group continued with the current medical care only. Findings demonstrated significantly greater reduction in activity limitations and pain intensity at post-treatment for the Internet treatment group and these effects were maintained at the three-month follow-up. Rate of clinically significant improvement in pain was also greater for the Internet treatment group than for the wait-list control group. There were no significant group differences in parental protectiveness or child depressive symptoms post-treatment. Internet treatment was rated as acceptable by all children and parents. Findings support the efficacy and acceptability of Internet delivery of family CBT for reducing pain and improving function among children and adolescents with chronic pain. To investigate whether the combination of standard medical care (SMC) and short-term cognitive-behavioral family treatment (CBT) in the treatment of recurrent abdominal pain (RAP) was more effective than SMC alone.
                Children recently diagnosed with RAP via physician examination were randomized into SMC (n = 29) and SMC plus CBT (n = 40) groups. Outcome measures included multiple dimensions of child and parent reported child pain, somatization, and functional disability, and school absences and physician contacts.
                Children and parents participating in the combined SMC + CBT intervention reported significantly less child and parent reported child abdominal pain than children in the SMC intervention immediately following the intervention and up to 1 year following study entry, as well as significantly fewer school absences. Significant differences in functional disability and somatization were not revealed.
                These results, in combination with previous studies, add support to the effectiveness of CBT intervention in reducing the sensory aspects of RAP. Results are discussed with respect to the cost-benefit of integrated medical and short-term psychological services. This study investigated the effectiveness of a brief Distraction Education intervention for parents prior to their preschool children's medical procedures. Forty-four preschool children with chronic non-life-threatening conditions were having intravenous catheters (IVs) placed for medical tests. Parent-child dyads were randomized into two groups. The experimental group received Distraction Education prior to IV insertion; the control group received standard care. Data were analyzed for two phases of the IV procedure. Phase 1 was the preparation for needle insertion; Phase 2 began with needle insertion. Experimental group parents used significantly more distraction than did control group parents during both phases (P < 0.001). There were no group differences for child behavioral distress or self-report of pain. There was a trend toward a group by phase interaction for behavioral distress (P = 0.07); more experimental group children showed decreased behavioral distress over time (from phase 1 to phase 2) than did control group children (P = 0.02). Unexplained abdominal pain in children has been shown to be related to parental responses to symptoms. This randomized controlled trial tested the efficacy of an intervention designed to improve outcomes in idiopathic childhood abdominal pain by altering parental responses to pain and children's ways of coping and thinking about their symptoms.
                Two hundred children with persistent functional abdominal pain and their parents were randomly assigned to one of two conditions-a three-session intervention of cognitive-behavioral treatment targeting parents' responses to their children's pain complaints and children's coping responses, or a three-session educational intervention that controlled for time and attention. Parents and children were assessed at pretreatment, and 1 week, 3 months, and 6 months post-treatment. Outcome measures were child and parent reports of child pain levels, function, and adjustment. Process measures included parental protective responses to children's symptom reports and child coping methods.
                Children in the cognitive-behavioral condition showed greater baseline to follow-up decreases in pain and gastrointestinal symptom severity (as reported by parents) than children in the comparison condition (time x treatment interaction, P<0.01). Also, parents in the cognitive-behavioral condition reported greater decreases in solicitous responses to their child's symptoms compared with parents in the comparison condition (time x treatment interaction, P<0.0001).
                An intervention aimed at reducing protective parental responses and increasing child coping skills is effective in reducing children's pain and symptom levels compared with an educational control condition. A randomized controlled trial was conducted to compare the efficacy of clinical hypnosis versus cognitive behavioral (CB) coping skills training in alleviating the pain and distress of 30 pediatric cancer patients (age 5 to 15 years) undergoing bone marrow aspirations. Patients were randomized to one of three groups: hypnosis, a package of CB coping skills, and no intervention. Patients who received either hypnosis or CB reported less pain and pain-related anxiety than did control patients and less pain and anxiety than at their own baseline. Hypnosis and CB were similarly effective in the relief of pain. Results also indicated that children reported more anxiety and exhibited more behavioral distress in the CB group than in the hypnosis group. It is concluded that hypnosis and CB coping skills are effective in preparing pediatric oncology patients for bone marrow aspiration. We evaluated the efficacy of cognitive-behavioral family intervention in the treatment of crises of pain in children with nonorganic recurrent abdominal pain (RAP) and the thresholds of pain for 17 body surface areas in these children.
                A randomized clinical trial was undertaken with 32 children between the ages of 5.1 and 13.9 years with nonorganic RAP. A group of 15 patients, aged 9.9 +/- 2.2 years (11 girls), received standard pediatric care and cognitive-behavioral family intervention for treatment of pain crises. The control group of 17 children, aged 8.4 +/- 2.0 years (11 girls), received only standard pediatric care. These procedures were undertaken by general pediatricians over 4 monthly sessions. An analog visual scale was used to measure the frequency and intensity of the pain crises per month and a mechanical pressure algometer for the measurement of pain threshold.
                The median frequency of pain crises per month reported by patients at the 3 monthly cognitive-behavioral family intervention sessions was 15, 5, 2 and 2, respectively. In contrast, the median frequency for pain crises per month reported by the control group was 12, 8, 10 and 8, respectively. The difference between the intervention group and the controls was statistically significant for frequency of pain at the second, third and fourth visits. There was no statistical difference for intensity of pain or for measured pain thresholds between the control and the intervention group.
                The cognitive-behavioral family intervention reduced the frequency of pain crises of children with nonorganic RAP. This successful intervention was carried out by the intervention of general pediatricians. Children and adolescents who seek medical treatment for persistent physical distress often suffer from co-occurring anxiety disorders. Treatment options for this impaired population are limited. This study tests the feasibility and potential efficacy of a cognitive-behavioral intervention targeting pain and anxiety for youth with impairing functional physical symptoms and anxiety disorders presenting to pediatricians for medical care.
                Children and adolescents (aged 8-16) experiencing somatic complaints, without an explanatory medical disorder (i.e., functional), were recruited from primary care and specialty (gastroenterologists and cardiologists) pediatricians. Forty children, primarily with gastrointestinal symptoms, who met criteria for a co-occurring anxiety disorder, were randomly assigned to a cognitive-behavioral treatment addressing pain and anxiety, Treatment of Anxiety and Physical Symptoms (TAPS), or to a waiting list control.
                TAPS was found to be an acceptable treatment for this population and was superior to the waiting list condition. Eighty percent of children in TAPS were rated as treatment responders by independent evaluators compared with none of the controls. Overall, self- and parent ratings indicated reductions in children's somatic discomfort and anxiety following intervention. TAPS participants maintained clinical gains 3 months following treatment.
                The study supports the feasibility and preliminary efficacy of a cognitive-behavioral intervention targeting co-occurring physical distress and anxiety in youth presenting for medical treatment. Such an approach has the potential to exert broad impact on children's dysfunction and to minimize exposure to invasive, ineffective, and costly medical procedures and treatments.
                © 2011 Wiley-Liss, Inc. Researchers have come to understand a great deal about pain mechanisms, especially in the past 30 years. This understanding has spawned the development of a number of psychological pain control strategies which have been extensively assessed for use with adults. Less is known about pain control strategies in children. The purpose of this study was to assess the value of 2 cognitive strategies (suggestion and music distraction) in reducing pain in children. Two hundred children, aged 4.5-6.5 years, receiving routine immunization injections were randomly assigned to one of the intervention groups in this factorial study. The groups were designated as: distraction, distraction with suggestion, suggestion and control. Subjects reported their pain using a 4-point pain scale. Distraction was found to significantly decrease pain whereas suggestion did not. Combining suggestion and distraction did not further enhance pain relief compared to use of distraction alone. Age was found to be an important determinant of the success of distraction. Furthermore, age was found to be related to amount of pain reported by children regardless of type of treatment. The results of this study support the use of music distraction in the reduction of injection pain in children. The purpose of this study was to investigate the effectiveness of a distraction technique in reducing a child's perceived pain and behavioral distress during an acute pain experience. A convenience sample of 100 children, ages 3 years 6 months through 12 years 11 months, scheduled for routine blood draws, was recruited and randomly assigned to an experimental or control group. During venipuncture, the control subjects received standard preparation, which consisted of being comforted by physical touch and soft voices, while experimental subjects were encouraged to use a kaleidoscope as a distraction technique. Results of the MANCOVA, with age as a covariate, indicated a significant difference between the groups. Univariate post hoc tests confirmed that the experimental group perceived less pain and demonstrated less behavioral distress than the control group. To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.
                Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.
                Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.
                There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps. Although several studies have illustrated the effectiveness of cognitive behavior therapy (CBT) on adult pain patients, there are few randomized controlled trials on children and adolescents. There is particularly a need for studies on pediatric patients who are severely disabled by longstanding pain syndromes. Acceptance and Commitment Therapy, as an extension of traditional CBT, focuses on improving functioning and quality of life by increasing the patient's ability to act effectively in concordance with personal values also in the presence of pain and distress. Following a pilot study, we sought to evaluate the effectiveness of an ACT-oriented intervention based on exposure and acceptance strategies and to compare this with a multidisciplinary treatment approach including amitriptyline (n=32). The ACT condition underwent a relatively brief treatment protocol of approximately 10 weekly sessions. Assessments were made before and immediately after treatment, as well as at 3.5 and 6.5 months follow-up. Prolonged treatment in the MDT group complicated comparisons between groups at follow-up assessments. Results showed substantial and sustained improvements for the ACT group. When follow-up assessments were included, ACT performed significantly better than MDT on perceived functional ability in relation to pain, pain intensity and to pain-related discomfort (intent-to-treat analyses). At post-treatment, significant differences in favor of the ACT condition were also seen in fear of re/injury or kinesiophobia, pain interference and in quality of life. Thus, results from the present study support previous findings and suggest the effectiveness of this ACT-oriented intervention for pediatric longstanding pain syndromes. Cognitive behavioral treatment has been incorporated into standard medical treatment procedures in German pain centers. Acceptance of the treatment by patients and outcome in terms of pain, coping, and disability was investigated. Components of the psychological treatment are education, relaxation and imagery, modifying thoughts and feelings, enhancement of pleasant activities, and training of good postural habits. The program was conducted in a group setting in accordance with a treatment manual and consists of 12 weekly 2.5-h sessions. A two-factor experiment with repeated measures on one factor was applied. Ninety-four consecutive patients with low-back pain were randomly assigned to an experimental group having a combined medical and cognitive-behavioral treatment, or to a control group with medical treatment only. Assessments were taken pre-treatment, post-treatment, and--in the treated group only--at a 6-months follow-up. At each assessment, patients kept a pain diary over a period of 4 weeks, and filled in self-report questionnaires. The sample consisted of 36 experimental and 40 control subjects at post-treatment. Experimental subjects reported less pain, better control over pain, more pleasurable activities and feelings, less avoidance and less catastrophizing. In addition, disability was reduced in terms of social roles, physical functions and mental performance. The results were maintained at follow-up. Patients who only received medical treatment showed little improvement. Data indicate that the program meets the needs of the patients and should be continued. There are currently no controlled studies of behavioral interventions for juvenile primary fibromyalgia syndrome (JPFM). In this small-sample randomized study, we tested the efficacy of a behavioral intervention, i.e., coping skills training (CST), for the treatment of adolescents with JPFM. Outcomes tested in this study were functional disability, pain intensity, pain-coping efficacy, and depressive symptoms.
                Thirty patients with JPFM were randomly assigned to 8 weeks of either CST or self-monitoring. Adolescents in the CST condition received training in active pain-coping techniques, while those in the self-monitoring condition monitored daily pain intensity and sleep quality with no instructions about behavior change. After posttreatment assessment, subjects were crossed over into the opposite treatment arm for 8 weeks (so that all adolescents eventually received both CST and self-monitoring) and were reassessed at Week 16.
                At Week 8, adolescents in both conditions showed significant decrease in depressive symptoms and functional disability. Those who received CST showed significantly greater ability to cope with pain than those in the self-monitoring condition and a trend toward decreased pain intensity. At Week 16, adolescents had significantly lower levels of disability and depressive symptoms compared to baseline, but those who received self-monitoring followed by CST seemed to receive the most benefit.
                CST can lead to improved functioning among JPFM patients. Although some of the improvement may be due to increased monitoring and attention, CST provides the specific benefit of improving adolescents' ability to cope with pain. The study had 2 aims---to determine the efficacy of a family-based cognitive-behavioral pain management intervention for adolescents with sickle cell disease (SCD) in (1) reducing pain and improving health-related variables and (2) improving psychosocial outcomes. Each adolescent and a family support person were randomly assigned to receive a brief pain intervention (PAIN) (n=27) or a disease education attention control intervention (DISEASE ED) (n=26) delivered at home. Assessment of primary pain and health-related variables (health service use, pain coping, pain-related hindrance of goals) and secondary psychosocial outcomes (disease knowledge, disease self-efficacy, and family communication) occurred at baseline (before randomization), postintervention, and 1-year follow-up. Change on outcomes did not differ significantly by group at either time point. When groups were combined in exploratory analyses, there was evidence of small to medium effects of intervention on health-related and psychosocial variables. Efforts to address barriers to participation and improve feasibility of psychosocial interventions for pediatric SCD are critical to advancing development of effective treatments for pain. Sample size was insufficient to adequately test efficacy, and analyses did not support this focused cognitive-behavioral pain management intervention in this sample of adolescents with SCD. Exploratory analyses suggest that comprehensive interventions, that address a broad range of skills related to disease management and adolescent health concerns, may be more effective in supporting teens during healthcare transition. Although literature provides support for cognitive behavioral therapy (CBT) as an efficacious intervention for social phobia, more research is needed to improve treatments for children.
                Forty four Caucasian children (ages 8-14) meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA, 1994) were randomly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells (n = 21) or a wait-list control group (n = 23). The primary outcome measure was clinical improvement. Secondary outcomes included improvements in anxiety coping, dysfunctional cognitions, interaction frequency and comorbid symptoms. Outcome measures included child report and clinican completed measures as well as a diagnostic interview.
                Significant differences between treatment participants (4 dropouts) and controls (2 dropouts) were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children. Furthermore, in the treatment group, significantly more children were free of diagnosis than in wait-list group at post-test. Additional child completed and clinician completed measures support the results.
                The study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia. Future research will need to compare this treatment to an active treatment group. There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate.
                Preliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children. Active comparators should be established with other evidence-based CBT programs for anxiety disorders, which differ significantly in their dosage and type of cognitive interventions from those of the manual under evaluation (e.g. Coping Cat). This study describes the results of a controlled clinical trial involving 44 7- to 14-year-old children with recurrent abdominal pain who were randomly allocated to either cognitive-behavioral family intervention (CBFI) or standard pediatric care (SPC). Both treatment conditions resulted in significant improvements on measures of pain intensity and pain behavior. However, the children receiving CBFI had a higher rate of complete elimination of pain, lower levels of relapse at 6- and 12-month follow-up, and lower levels of interference with their activities as a result of pain and parents reported a higher level of satisfaction with the treatment than children receiving SPC. After controlling for pretreatment levels of pain, children's active self-coping and mothers' caregiving strategies were significant independent predictors of pain behavior at posttreatment. Pregnant injecting drug users were randomly assigned to: (i) individually receive a six-session cognitive-behavioural intervention in addition to their usual methadone maintenance treatment (intervention condition (I) (n = 40)); or (ii) their usual methadone maintenance treatment only (control condition (C) (n = 40)). There was no change in drug use per se in either group after the intervention. However, at 9-month follow-up the I group had significantly reduced some HIV risk-taking behaviours (in particular injecting risk behaviours). The I group reduced the needle risk associated both with "typical" use (drug use in the month before interview) and "binge" use (drug use in the month nominated as the heaviest month of drug use in the previous 6 months). The intervention had no effect on sexual risk behaviours. The finding of reduced injecting risk behaviour following the six-session intervention suggests that such an intervention may be of benefit for individuals persisting with injecting risk behaviours despite methadone maintenance treatment and the availability of sterile injection equipment. Individuals reporting chronic, nonmalignant pain for at least 6 months (N=114) were randomly assigned to 8 weekly group sessions of acceptance and commitment therapy (ACT) or cognitive-behavioral therapy (CBT) after a 4-6 week pretreatment period and were assessed after treatment and at 6-month follow-up. The protocols were designed for use in a primary care rather than specialty pain clinic setting. All participants remained stable on other pain and mood treatments over the course of the intervention. ACT participants improved on pain interference, depression, and pain-related anxiety; there were no significant differences in improvement between the treatment conditions on any outcome variables. Although there were no differences in attrition between the groups, ACT participants who completed treatment reported significantly higher levels of satisfaction than did CBT participants. These findings suggest that ACT is an effective and acceptable adjunct intervention for patients with chronic pain.
                Published by Elsevier B.V. Few controlled clinical trials of psychological interventions for cancer pain relief exist in spite of frequent support for their importance as adjuncts to medical treatment. This study compared oral mucositis pain levels in 4 groups of cancer patients receiving bone marrow transplants (BMT): (1) treatment as usual control, (2) therapist support, (3) relaxation and imagery training, and (4) training in a package of cognitive-behavioral coping skills which included relaxation and imagery. A total of 94 patients completed the study which involved two training sessions prior to treatment and twice a week 'booster' sessions during the first 5 weeks of treatment. Results confirmed our hypothesis that patients who received either relaxation and imagery alone or patients who received the package of cognitive-behavioral coping skills would report less pain than patients in the other 2 groups. The hypothesis that the cognitive-behavioral skills package would have an additive effect beyond relaxation and imagery alone was not confirmed. Average visual analogue scale (VAS) report of pain within the therapist support group was not significantly lower than the control group (P = 0.103) nor significantly higher than the training groups. Patient reports of relative helpfulness of the interventions for managing pain and nausea matched the results of VAS reports. From these results, we conclude that relaxation and imagery training reduces cancer treatment-related pain; adding cognitive-behavioral skills to the relaxation with imagery does not, on average, further improve pain relief.
Overall, there is preliminary evidence that a variety of cognitive-behavioral interventions can be used with children and adolescents to successfully manage or reduce pain and distress associated with needle-related procedures. However, many of the included studies received lower quality scores because they failed to describe the randomization procedure and participant withdrawals or drop-outs from the study. Further RCTs need to be conducted, particularly for the many interventions for which we could not locate any trials.