Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain.

Digitally delivered behavioral interventions for chronic pain have been encouraging with effects similar to face-to-face treatment. Although many chronic pain patients benefit from behavioral treatment, a substantial proportion do not improve. To contribute to more knowledge about factors that predict treatment effects in digitally delivered behavioral interventions for chronic pain, the present study analyzed pooled data (N = 130) from three different studies on digitally delivered Acceptance and Commitment Therapy (ACT) for chronic pain. Longitudinal linear mixed-effects models for repeated measures were used to identify variables with significant influence on the rate of improvement in the main treatment outcome pain interference from pre- to post-treatment. The variables were sorted into six domains (demographics, pain variables, psychological flexibility, baseline severity, comorbid symptoms and early adherence) and analysed in a stepwise manner. The study found that shorter pain duration and higher degree of insomnia symptoms at baseline predicted larger treatment effects. The original trials from which data was pooled are registered at clinicaltrials.gov (registration number: NCT03105908 and NCT03344926).

Moderators of long-term treatment outcome when comparing two group interventions for adolescents with ADHD: who benefits more from DBT-based skills training?

BACKGROUND: Psychosocial interventions for adolescents with attention-deficit/hyperactivity disorder (ADHD), targeting emotional dysregulation and impulsive behaviors, have been requested, but the heterogeneity within this group makes it unlikely that there is one treatment that fits all. The aim of this study was to identify which adolescents with ADHD might have an effect from a structured skills training group (SSTG) based on dialectical behavioral therapy, by exploring pre-treatment characteristics as potential moderators of long-term treatment outcome. METHODS: This study was based on follow-up data from a randomized controlled trial comparing the SSTG (n = 71) to a psychoeducational control intervention (n = 57) for adolescents with ADHD (15-18 years old). Clinical characteristics (sex, age, medication status, ADHD presentation, severity of ADHD symptom, psychiatric comorbidity, impairment of emotional dysregulation and functional impairment) were explored as potential moderators of pre-treatment to follow-up change in ADHD symptoms and functional impairment. Moderation analyses were performed using the PROCESS macro for SPSS. RESULTS: Three moderators (severity of hyperactivity/impulsivity, conduct problems and impairment of emotional dysregulation) were identified in regard to the outcome self-rated change in ADHD symptoms. Participants with elevated pre-scores on these variables had a better effect of the SSTG than of the psychoeducational control intervention. No moderators were found in regard to the parental-rated outcomes. CONCLUSIONS: The SSTG seems to be beneficial for adolescents with ADHD who perceive pronounced symptoms of hyperactivity/impulsivity, conduct problems and emotional dysregulation. Our findings need to be confirmed in future trials evaluating dialectical behavioral therapy-based skills training for adolescents with ADHD, where these moderators could be used as criteria for inclusion or stratification. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN17366720 , retrospectively registered.

Psychological and social risk factors associated with development of psychopathology, controlling for biological influence.

PURPOSE OF REVIEW: To evaluate and summarize recent research investigating psychological, social and environmental risk factors for development of psychopathology in childhood, while controlling for biological (genetic) influences by using a matched sibling, twin or adoptee design. RECENT FINDINGS: Nineteen studies were included, of which eleven were longitudinal and eight were cohort studies. Included studies used adequate designs and statistical methods, controlled for unmeasured confounders and, in many cases, for other measured risk factors. None of the studies used the framework for environmental factors presented in the International Classification of Functioning, Disability and Health (ICF). The outcome variable psychopathology was rarely assessed using a diagnostic standard. The findings were sorted in five themes based on included exposures: 'Social support, social rejection and perceived identity,' 'Early symptoms of psychopathology,' 'Antibiotic exposure,' 'Factors in the family' and 'Nature versus nurture'. SUMMARY: Using twin/sibling/adoptee designs, a number of unique predictors of psychopathology were found, even when controlling for familial confounders and other specified risk factors. Future studies of psychopathology development should benefit from longitudinal, genetically sensitive designs and from use of diagnostic standards for psychopathology outcome, and should also incorporate ICF for classification of risk factors.

Internet-delivered acceptance and commitment therapy as microlearning for chronic pain: A randomized controlled trial with 1-year follow-up.

BACKGROUND: Studies of Internet-delivered acceptance and commitment therapy (ACT) for chronic pain have shown small to moderate positive effects for pain interference and pain acceptance. Effects on pain intensity, depression, anxiety and quality of life (QoL) have been less favourable, and improvements for values and sleep are lacking. In this randomized controlled trial iACT - a novel format of Internet-ACT using daily microlearning exercises - was examined for efficacy compared to a waitlist condition. METHODS: Adult participants (mean age 49.5 years, pain duration 18.1 years) with diverse chronic pain conditions were recruited via self-referral, and randomized to iACT (n = 57) or waitlist (n = 56). The primary outcome was pain interference. The secondary outcomes were QoL, depression, anxiety, insomnia and pain intensity. The process variables included psychological inflexibility and values. Post-assessments were completed by 88% (n = 100) of participants. Twelve-month follow-up assessments were completed by 65% (iACT only, n = 37). Treatment efficacy was analysed using linear mixed models and an intention-to-treat-approach. RESULTS: Significant improvements in favour of iACT were seen for pain interference, depression, anxiety, pain intensity and insomnia, as well as process variables psychological inflexibility and values. Between-group effect sizes were large for pain interference (d = 0.99) and pain intensity (d = 1.2), moderate for anxiety and depressive symptoms and small for QoL and insomnia. For the process variables, the between-group effect size was large for psychological inflexibility (d = 1.0) and moderate for values. All improvements were maintained at 1-year follow-up. CONCLUSIONS: Internet-ACT as microlearning may improve a broad range of outcomes in chronic pain. SIGNIFICANCE: The study evaluates a novel behavioral treatment with positive results on pain interference, mood as well as pain intensity for longtime chronic pain sufferers. The innovative format of a digital ACT intervention delivered in short and experiential daily learnings may be a promising way forward.

Internet-delivered cognitive behaviour therapy for adolescents with insomnia comorbid to psychiatric conditions: A non-randomised trial.

Insomnia is highly prevalent among adolescents with psychiatric conditions and is known to aggravate psychiatric symptoms. Research on cognitive behaviour therapy for adolescents with comorbid insomnia (CBT-I) is still limited. The aim of this study was to investigate feasibility and preliminary effects of internet-delivered CBT for adolescents with insomnia comorbid to a psychiatric condition. Twenty-one patients (13-17 years) with comorbid insomnia were recruited from Child and Adolescent Psychiatry. All patients received 7 weeks of internet-delivered CBT-I with therapist support. Outcomes were assessed at baseline, post-treatment, and at a 4-month follow-up. The proportion of completed assessments was overall acceptable. Participants on average completed 4.48 (sd = 1.97) of the seven treatment modules and therapists on average spent 12.80 minutes (sd = 6.23) per patient and week. Results showed large statistically significant improvements on insomnia severity, sleep efficiency, sleep onset latency and sleep quality. Medium to large improvements were also seen on the psychiatric symptoms of depression, obsessive-compulsive symptoms, interpersonal sensitivity, paranoid ideation and psychoticism. These findings indicate that internet-delivered CBT is feasible and potentially promising for improving sleep and reducing psychiatric symptoms in adolescent psychiatric patients with insomnia and co-morbid psychiatric disorders. A larger randomised trial is warranted to verify these preliminary results.

ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial.

BACKGROUND: Acceptance and commitment therapy (ACT) is a behavioral health intervention with strong empirical support for chronic pain but, to date, widespread dissemination is limited. Digital solutions improve access to care and can be integrated into patients' everyday lives. OBJECTIVE: ACTsmart, a guided smartphone-delivered ACT intervention, was developed to improve the accessibility of an evidence-based behavioral treatment for chronic pain. In the present study, we evaluated the preliminary efficacy of ACTsmart in adults with chronic pain. METHODS: The study was an open-label pilot trial. The treatment lasted for 8 weeks, and participants completed all outcome measures at pretreatment and posttreatment and at 3-, 6-, and 12-month follow-ups, with weekly assessments of selected measures during treatment. The primary outcome was pain interference. The secondary outcomes were psychological flexibility, values, insomnia, anxiety, depressive symptoms, health-related quality of life, and pain intensity. All outcomes were analyzed using linear mixed-effects models. RESULTS: The sample consisted of 34 adults (88% women) with long-standing chronic pain (M=20.4 years, SD=11.7). Compliance to treatment was high, and at the end of treatment, we observed a significant improvement in the primary outcome of pain interference (d = -1.01). All secondary outcomes significantly improved from pretreatment to posttreatment with small to large effect sizes. Improvements were maintained throughout 12 months of follow-up. CONCLUSION: The results of this pilot study provide preliminary support for ACTsmart as an accessible and effective behavioral health treatment for adults with chronic pain and warrant a randomized controlled trial to further evaluate the efficacy of the intervention.

Internet-Delivered Acceptance and Commitment Therapy for Adolescents with Chronic Pain and Their Parents: A Nonrandomized Pilot Trial.

BACKGROUND: Acceptance and Commitment Therapy (ACT) is an empirically supported treatment for chronic pain in adults. There is also a small but growing evidence base of ACT for pediatric chronic pain. However, because of limited access to psychological treatment for pain, and geographical distances from pain facilities, many patients will not receive such treatment. OBJECTIVE: The aim of the study was to evaluate the feasibility and preliminary effects of an internet-delivered ACT for adolescents with chronic pain, and their parents. METHODS: In this nonrandomized pilot study 28 self-recruited adolescents, aged 13-17 years, received 8 weeks of internet-delivered ACT, while outcomes were assessed at pre-, posttreatment, and at follow-up (17-25 weeks). Parents of the adolescents received an 8-week internet-delivered parental program, and their outcomes were assessed at the same timepoints. Both treatments were guided by a therapist experienced in ACT and chronic pain. RESULTS: Some threats to feasibility were identified such as slow recruitment rate, low compliance and a delay in completion of follow-up assessments. Preliminary outcome evaluation showed that adolescents showed a large significant improvement on their main outcome (pain interference, d = 1.09), and parents a medium improvement on their main outcome, pain reactivity (d = 0.70). Improvements were also seen in adolescents' depressive symptoms and insomnia severity. CONCLUSION: The preliminary results of internet-delivered ACT are promising with regards to improvements in adolescent and parent outcome. Measures to improve feasibility are needed prior to conducting a larger randomized trial.

Internet-delivered acceptance and commitment therapy (iACT) for chronic pain-feasibility and preliminary effects in clinical and self-referred patients.

BACKGROUND: Acceptance and commitment therapy (ACT) is an evidence-based treatment to improve functioning and quality of life (QoL) for chronic pain patients, but outreach of this treatment is unsatisfactory. Internet-delivery has been shown to increase treatment access but there is limited evidence regarding feasibility and effectiveness of web-based ACT for chronic pain. The aim of the study was to evaluate and iterate a novel internet-delivered ACT program, iACT, in a clinical and a self-referred sample of chronic pain patients. The intervention was developed in close collaboration with patients. To enhance learning, content was organized in short episodes to promote daily engagement in treatment. In both the clinical and self-referred samples, three critical domains were evaluated: (I) feasibility (acceptability, practicality and usage); (II) preliminary efficacy on pain interference, psychological inflexibility, value orientation, QoL, pain intensity, anxiety, insomnia and depressive symptoms; and (III) potential treatment mechanisms. METHODS: This was an open pilot study with two samples: 15 patients from a tertiary pain clinic and 24 self-referred chronic pain participants, recruited from October 2015 until January 2017. Data were collected via an online platform in free text and self-report measures, as well as through individual oral feedback. Group differences were analyzed with Chi square-, Mann-Whitney U- or t-test. Preliminary efficacy and treatment mechanism data were collected via self-report and analyzed with multilevel linear modeling for repeated measures. RESULTS: Feasibility: patient feedback guided modifications to refine the intervention and indicated that iACT was acceptable in both samples. User insights provided input for both immediate and future actions to improve feasibility. Comprehensiveness, workability and treatment credibility were adequate in both samples. Psychologists spent on average 13.5 minutes per week per clinical patient, and 8 minutes per self-referred patient (P=0.004). Recruitment rate was 24 times faster in the self-referred sample (24 patients in 1 month, compared to 15 patients in 15 months, P<0.001) and the median distance to the clinic was 40 km in the clinical sample, and 426 km in the self-referred sample (P<0.001). Preliminary effects: post-assessments were completed by 26 participants (67%). Significant effects of time were seen from pre- to post-treatment across all outcome variables. Within group effect sizes (Cohen's d) at post-treatment ranged from small to large: pain interference (d=0.64, P<0.001), psychological inflexibility (d=1.43, P<0.001), value progress (d=0.72, P<0.001), value obstruction (d=0.42, P<0.001), physical QoL (d=0.41, P=0.005), mental QoL (d=0.67, P=0.005), insomnia (d=0.31, P<0.001), depressive symptoms (d=0.47, P<0.001), pain intensity (d=0.78, P=0.001) and anxiety (d=0.46, P<0.001). Improvements were sustained at 1-year follow-up. Psychological inflexibility and value progress were found to be potential treatment mechanisms. CONCLUSIONS: The results from the present study suggests that iACT was feasible in both the clinical and the self-referred sample. Together with the positive preliminary results on all outcomes, the findings from this feasibility study pave the way for a subsequent large randomized efficacy trial.

ACTsmart - development and feasibility of digital Acceptance and Commitment Therapy for adults with chronic pain.

Accessibility of evidence-based behavioral health interventions is one of the main challenges in health care and effective treatment approaches are not always available for patients that would benefit from them. Digitization has dramatically changed the health care landscape. Although mHealth has shown promise in addressing issues of accessibility and reach, there is vast room for improvements. The integration of technical innovations and theory driven development is a key concern. Digital solutions developed by industry alone often lack a clear theoretical framework and the solutions are not properly evaluated to meet the standards of scientifically proven efficacy. On the other hand, mHealth interventions developed in academia may be theory driven but lack user friendliness and are commonly technically outdated by the time they are implemented in regular care, if they ever are. In an ongoing project aimed at scientific innovation, the mHealth Agile Development and Evaluation Lifecycle was used to combine strengths from both industry and academia in the development of ACTsmart - a smartphone-based Acceptance and Commitment Therapy treatment for adult chronic pain patients. The present study describes the early development of ACTsmart, in the process of moving the product from alpha testing to a clinical trial ready solution.

Psychological Flexibility as a Resilience Factor in Individuals With Chronic Pain.

Resilience factors have been suggested as key mechanisms in the relation between symptoms and disability among individuals with chronic pain. However, there is a need to better operationalize resilience and to empirically evaluate its role and function. The present study examined psychological flexibility as a resilience factor in relation to symptoms and functioning among 252 adults with chronic pain applying for participation in a digital ACT-based self-help treatment. Participants completed measures of symptoms (pain intensity, and anxiety), functioning (pain interference and depression), as well as the hypothesized resilience factor psychological flexibility (measured as avoidance, value obstruction, and value progress). As expected, symptoms, functioning and resilience factors were significantly associated. Hierarchical linear regression analyses showed that psychological flexibility significantly contributed to the prediction of pain interference and depression when adjusting for age, pain and anxiety. Also, participants with low levels of psychological flexibility were more likely to be on sick leave. Furthermore, a series of multiple mediation analyses showed that psychological flexibility had a significant indirect effect on the relationship between symptoms and functioning. Avoidance was consistently shown to contribute to the indirect effect. Results support previous findings and suggest the importance of psychological flexibility as a resilience factor among individuals with chronic pain and anxiety.

Randomised controlled non-inferiority trial with 3-year follow-up of internet-delivered versus face-to-face group cognitive behavioural therapy for depression.

BACKGROUND: Guided internet-delivered cognitive behaviour therapy (ICBT) has been found to be effective in the treatment of mild to moderate depression, but there have been no direct comparisons with the more established group-based CBT with a long-term follow-up. METHOD: Participants with mild to moderate depression were recruited from the general population and randomized to either guided ICBT (n=33) or to live group treatment (n=36). Measures were completed before and after the intervention to assess depression, anxiety, and quality of life. Follow-ups were conducted at one-year and three-year after the treatment had ended. RESULTS: Data were analysed on an intention-to-treat basis using linear mixed-effects regression analysis. Results on the self-rated version of the Montgomery-Åsberg Depression Scale showed significant improvements in both groups across time indicating non-inferiority of guided ICBT, and there was even a tendency for the guided ICBT group to be superior to group-based CBT at three year follow-up. Within-group effect sizes for the ICBT condition at post-treatment showed a Cohen's d=1.46, with a similar large effect at 3-year follow-up, d=1.78. For the group CBT the corresponding within-group effects were d=0.99 and d=1.34, respectively. LIMITATIONS: The study was small with two active treatments and there was no placebo or credible control condition. CONCLUSIONS: Guided ICBT is at least as effective as group-based CBT and long-term effects can be sustained up to 3 years after treatment.