Who benefits from guided internet-based interventions? A systematic review of predictors and moderators of treatment outcome

Objective: To our knowledge, no systematic review or meta-analysis has been conducted on all predictors or moderators of treatment outcome across diagnoses in guided internet-based interventions (IBIs) for adults. We aimed to aggregate the results of relevant studies and identify research gaps. Methods: After duplicate removal, 1615 articles, identified by searching the databases PsycInfo, Ovid Medline, and Pubmed and through snowballing, were screened following detailed in- and exclusion criteria in April and May 2021. Risk of bias (QUIPS) and intra- and interrater reliability for screening and risk of bias were assessed. Variables were grouped and categorized, then synthesized using vote counting based on direction of effect. Results: N=50 articles were included in the review. Seventy-seven predictors or moderators were generated, of which adherence, baseline symptoms, education, age, and gender were most frequently assessed. Adherence, treatment credibility, working alliance, and baseline scores emerged as conclusive predictors/moderators. Results for other variables were mainly inconsistent or inconclusive. Conclusion: Our review highlights that it is currently difficult to predict, across diagnoses, who will benefit from guided IBIs. Further rigorous research is needed to identify predictors and moderators based on a sufficient number of studies. PROSPERO registration: CRD42021242305.

Predictors of adherence to an internet-based cognitive behavioral therapy program for individuals with chronic pain and comorbid psychological distress

Background The burden caused by chronic pain is significant, affecting at least 10 percent of the world´s population. While internet-based treatments based on cognitive behavioral therapy (CBT) have been shown to be promising in this area, attrition levels vary significantly. The purpose of this study was to investigate predictor variables for participants’ adherence to an internet-based CBT treatment for individuals with chronic pain as well as to investigate associations between adherence and treatment outcome. Methods Data for this study was retrieved from a randomized controlled trial including 95 individuals with chronic pain who received internet-based CBT. Treatment adherence was studied through three outcome variables: treatment progress, treatment completion and exercise completion. The predictor variables were grouped into four clusters: background variables (age, gender, marital status, level of education, and typical computer usage); the second cluster included health status variables (sick leave, current psychiatric diagnosis, previous psychotherapy for pain, current pharmacological treatment, previous depression, current depression, and current depressive symptoms); the third cluster included pain-related variables (opioid medication, history of pain, and pain symptoms) and the fourth cluster included motivation variables (measured with treatment preference, treatment credibility, compliance to the treatment schedule and contact with the therapists). Results Findings showed that treatment progress was predicted by higher treatment credibility at baseline, whereas participants who were behind schedule in the second week of the program finished fewer treatment modules. When analyzing each cluster of predictor variables separately, current depressive symptoms also predicted fewer completed treatment modules. Among the pain-related variables, higher pain acceptance was the only predictor for completing more treatment modules. Treatment completion (which in this study was defined as having completed at least 75% of treatment modules) was predicted by higher treatment credibility and fewer depressive symptoms at baseline, and was thus similar to the results regarding treatment progress. Finally, all adherence variables predicted the treatment outcome pain interference. Conclusions Low treatment credibility, depressive symptoms and falling behind the treatment schedule early on were the most important predictor variables for low treatment adherence, while a number of demographical and pain-related variables were not related to adherence. The results from this study may help clinicians identify patients who are less likely to complete, and thus benefit from, their pain treatment. Trial registration ClinicalTrials.gov NTC03316846.

Effect of Combined Bee Venom Acupuncture and NSAID Treatment for Non-Specific Chronic Neck Pain: A Randomized, Assessor-Blinded, Pilot Clinical Trial

This study aimed to investigate the feasibility of a combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of non-specific chronic neck pain (NCNP). Patients with NCNP for ≥3 months were randomly allocated to a BVA, NSAIDs, or combined group (1:1:1), receiving 6 sessions of BVA, loxoprofen (180 mg daily), or a combination, respectively, for 3 weeks. Recruitment, adherence, and completion rates were calculated to assess feasibility. Bothersomeness, pain, disability, quality of life, depressive status, treatment credibility, and adverse events were assessed. In total, 60 participants were enrolled, and 54 completed the trial. Recruitment, adherence, and completion rates were 100%, 95%, and 90%, respectively. Bothersomeness, pain, disability, and depressive symptoms significantly improved in all groups after treatment (p < 0.05). The combined group showed continuous improvement during the follow-up period (p < 0.05). Quality of life was significantly improved (p < 0.05), and treatment credibility was maintained in the BVA and combined groups. No serious adverse events were reported. Combined treatment of BVA and NSAIDs are feasible for the treatment of NCNP, showing high persistence of the effect, credibility, and safety. Additional trials with longer follow-up are needed to confirm this effect.

Does Health Literacy Make a Difference? Comparing the Effect of Conventional Medicine Versus Homeopathic Prescribing on Treatment Credibility and Expectancy

ObjectiveWhile homeopathic remedies are often used to treat non-specific complaints such as headaches, empirical evidence suggests their treatment effect is due to the placebo effect. Low health literacy seems to be connected to higher use of complementary and alternative medicine (CAM). The aim of this study was to examine what people with occasional headaches expect from conventional medicine or homeopathic remedies and if health literacy interacts with this expectation.MethodsIn this experimental study, n = 582 participants with occasional headaches were randomized to read one of two vignettes, which described the prescription of either conventional medicine or a homeopathic remedy. Subsequently, the participants were asked to rate treatment credibility and expectancy with regard to their assigned vignette. Health literacy was assessed as a potential moderator.ResultsParticipants in the conventional medicine group rated treatment credibility and expectancy higher than in the homeopathic remedy group. Moderation analysis revealed that when being offered conventional medicine, participant reports of treatment credibility and expectancy decreased with lower health literacy, while these outcomes increased with lower health literacy for homeopathic remedies.DiscussionPeople with occasional headaches estimate the effectiveness of conventional medication properly. However, health care professionals should pay special attention to patients with low health literacy, as they might need more time and information to give their informed consent.

355 Predictors of Longitudinal Sleep Outcomes in a Statewide Randomized Trial of Telephone Cognitive Behavioral Therapy for Insomnia

Introduction We examined the relationship between treatment process measures and 12-month insomnia outcomes from a large clinical trial of telephone-delivered CBT-I. Methods A statewide sample of 327 Kaiser Permanente Washington members aged 60+ with OA, Insomnia Severity Index (ISI) scores of 11+ and Brief Pain Inventory scores of 9+ were randomized to six sessions of individual telephone-delivered cognitive-behavior therapy for insomnia (CBT-I) vs. education-only control. Participants rated their perceptions of treatment credibility and perceived effectiveness on a 7-point Likert scale after session 1 and at 2-month post-test. They also completed the Sleep Hygiene Index (SHI), the 8-item Sleep Problem Acceptance Questionnaire (SPAQ), and the 8-item Chronic Pain Acceptance Questionnaire (CPAQ) at baseline, post-treatment, and 12 months. Insomnia outcome was measured using the ISI. Results Participants (mean age=70.2 years [SD=6.81], 74.6% female, 87.8% with sleep problems for over 1 year) were randomized to the two treatment arms. Regression analyses controlling for baseline age, opioid use, depression, pain, and ISI showed that lower 12-month ISI scores were associated with CBT-I group membership and lower baseline ISI (both p&lt;.001), higher session 1 ratings of treatment credibility (p=.004), higher baseline CPAQ activity engagement (AE) subscale scores (p=.04), and lower baseline SPAQ AE scores (p=.016) when predictors were simultaneously entered. Lower 12-month ISI scores were also associated with post-test ratings of treatment perceived effectiveness (p=.004) and higher SPAQ AE (p=.038) scores. Improvements on the SHI at post-test were significantly associated with lower 12-month ISI scores when variables were entered singly into regression models, but not when all predictors were entered simultaneously. SPAQ and CPAQ sleep and pain willingness subscale scores were not significantly related to ISI outcomes in any model. Conclusion People with less severe baseline insomnia levels who received telephone-delivered CBT-I were more likely to have lower 12-month ISI scores. Participant perceptions of treatment credibility and effectiveness, and engagement in life activities despite pain and sleep symptoms were also associated with long-term improvements in insomnia, but willingness to experience sleep and pain symptoms were not contributing factors. Support (if any) This work was supported by PHS grant 5R01AG053221.

Transfer of face-to-face group therapies into online group-chats in a psychiatric outpatient setting during the COVID-19 pandemic (Preprint)

BACKGROUND At the height of the COVID-19 pandemic, several mental health care providers were obliged to shut down outpatient services, including group therapies and psychoeducational sessions. The lockdown in many countries is a serious threat for mental well-being, especially for individuals with severe mental illnesses. Discontinued outpatient treatments and a disruption of daily routines are considered to be a risk factor for destabilization of mentally ill patients. OBJECTIVE The aim of the present study was to develop and to evaluate the acceptability, usability, and feasibility of a group-chat program to replace cancelled face-to-face (f2f) group sessions in an outpatient psychiatric department. METHODS Participants (n = 38) were recruited in the outpatient department of a large university medical center in Leipzig, Germany. Former f2f group participants were invited to take part in a therapist-guided group-chat for four weeks (eight sessions) and were asked to evaluate the program via self-administered standardized questionnaires at baseline (T0, pre-intervention), after every chat session (T1), and post-treatment (T2, after 4-6 weeks). The chat groups were specific to the following mental disorder diagnoses and based on the same therapeutic principles and techniques as the former f2f groups: anxiety, depression, obsessive-compulsive disorder (OCD), and adult attention deficit hyperactivity disorder (ADHD). Sociodemographic measures, attitudes towards the COVID-19 pandemic, depressive symptoms (PHQ-9), quality of life (WHOQOL-BREF), treatment credibility/expectancy (CEQ), and participants’ satisfaction (ZUF-8) were measured. RESULTS Participants joined an average of n = 5.0 out of eight offered chat sessions. Participation rates in the respective groups were highest in the ADHD group (78.2%) and lowest in the anxiety group (41.1%). The overall pre-intervention level of depressive symptoms was moderate and showed a slight, non-significant improvement at post-treatment (T0: M = 10.7, SD = 5.5; T2: M = 10.2, SD = 5.5). A similar result was observed regarding quality of life (T0: Median = 41.7 - 68.8; T2: Median = 50.0 - 70.3). Treatment credibility and expectancy scores were medium high (T0: Mcred = 18.1, SD = 3.8; Mexp = 11.2, SD = 5.1; T2: Mcred = 17.1, SD = 4.8; Mexp = 10.3, SD = 5.8). Further, significant correlations were detected between post-treatment expectancy score and post-treatment PHQ-9 score (r = -0.41; p = .024), post-treatment physical quality of life (r = 0.54; p = .001) and post-treatment psychological quality of life (r = 0.53; p = .002). Overall, participants’ satisfaction with the program was very high, both after chat sessions and at post-treatment (ZUF-8: M = 20.6, SD = 1.0). Of all participants, a majority (87.1%) rated the program as excellent/good and would recommend the group-chat program to a friend in need of similar help (83.9%). CONCLUSIONS A therapist-guided group-chat program to substitute outpatient group-setting treatment during the COVID-19 lockdown was shown to be feasible, usable, and highly acceptable for participants. Online programs, such as this one, provide an easy to implement tool to successfully stabilize participants during a difficult pandemic time. CLINICALTRIAL This study is registered in the German Clinical Trials Register: DRKS00021527.

Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial

Background: Patients with fibromyalgia (FM) frequently resort to osteopathic or chiropractic treatment, despite very weak supporting evidence. We aimed to assess the efficacy of osteopathic manipulation in FM in a properly controlled and powered randomized clinical trial. Methods: Patients were randomized to osteopathic or sham treatment. Treatment was administered by experienced physical medicine physicians, and consisted of six sessions per patient, over 6 weeks. Treatment credibility and expectancy were repeatedly evaluated. Patients completed standardized questionnaires at baseline, during treatment, and at 6, 12, 24, and 52 weeks after randomization. The primary outcome was pain intensity (100-mm visual analog scale) during the treatment period. Secondary outcomes included fatigue, functioning, and health-related quality of life. We performed primarily intention-to-treat analyses adjusted for credibility, using multiple imputation for missing data. Results: In total, 101 patients (94% women) were included. Osteopathic treatment did not significantly decrease pain relative to sham treatment (mean difference during treatment: −2.2 mm; 95% confidence interval, −9.1 to 4.6 mm). No significant differences were observed for secondary outcomes. No serious adverse events were observed, despite a likely rebound in pain and altered functioning at week 12 in patients treated by osteopathy. Patient expectancy was predictive of pain during treatment, with a decrease of 12.9 mm (4.4–21.5 mm) per 10 points on the 0–30 scale. Treatment credibility and expectancy were also predictive of several secondary outcomes. Conclusion: Osteopathy conferred no benefit over sham treatment for pain, fatigue, functioning, and quality of life in patients with FM. These findings do not support the use of osteopathy to treat these patients. More attention should be paid to the expectancy of patients in FM management.

Feasibility of Superimposed Neuromuscular Electrical Stimulation to the Gluteus Medius During a Resistance Training Program

Context: Gluteus medius (GMed) weakness is a common impairment seen across multiple lower-extremity pathologies. Greater GMed weakness is moderately associated with greater frontal plane motion, often termed dynamic knee valgus during functional tasks which may increase risk of lower-extremity injury. Neuromuscular electrical stimulation (NMES) superimposed to targeted muscles has emerged in clinical practice; however, NMES superimposed to the GMed in unknown. It is essential to assess the safety, credibility, and expectancy of NMES superimposed to the GMed prior to implementation in clinical practice. The objective of this study was to evaluate feasibility, safety, credibility, and expectancy of improvement with a 2-week intervention with or without NMES to the GMed in females with dynamic knee valgus. Design: Feasibility study. Methods: A total of 22 adult females with dynamic knee valgus (age = 21.8 [1.4] y, mass = 76.9 [18.8] kg, height = 1.7 [0.1] m) completed a 2-week intervention with NMES or a sham treatment superimposed to the GMed during all therapeutic exercises. Feasibility was assessed by recruitment and completion rate, while safety was assessed by the total number of adverse events. Treatment credibility and expectancy was assessed with the Credibility Expectancy Questionnaire. Mixed-measure analysis of variance were used for statistical analysis (P ≤ .05). Results: Recruitment was completed in 5 months with 100% completion rate and no adverse events. There was no difference in treatment credibility between groups (NMES = 23.7 [2.3], sham = 21.7 [3.4], P = .12); however, the NMES group demonstrated a greater expectancy score (NMES = 20.0 [3.8], sham = 15.9 [5.1], P = .045). Conclusion: Resistance training with NMES superimposed to the GMed is a feasible and safe intervention that resulted in greater expectance of success. Clinicians may consider superimposing NMES to the gluteal muscles when addressing muscle weakness in individuals with dynamic knee valgus.

Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial

Study Objectives In a randomized controlled noninferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of cognitive-behavioral therapy (CBT) for insomnia for improving insomnia/sleep and daytime functioning at posttreatment and 3-month follow-up. A secondary objective compared the modalities on treatment credibility, satisfaction, and therapeutic alliance. Methods A total of 65 adults with chronic insomnia (46 women, 47.2 ± 16.3 years of age) were randomized to 6 sessions of CBT for insomnia delivered individually via AASM SleepTM (n = 33, CBT-TM) or face-to-face (n = 32, CBT-F2F). Participants completed sleep diaries, the Insomnia Severity Index (ISI), and daytime functioning measures at pretreatment, posttreatment, and 3-month follow-up. Treatment credibility, satisfaction, and therapeutic alliance were compared between treatment modalities. The ISI was the primary noninferiority outcome. Results Based on a noninferiority margin of four points on the ISI and, after adjusting for confounders, CBT-TM was noninferior to CBT-F2F at posttreatment (β = 0.54, SE = 1.10, 95% CI = 1.64 to 2.72) and follow-up (β = 0.34, SE = 1.10, 95% CI = 1.83 to 2.53). Daytime functioning measures, except the physical composite scale of the SF-12, were significantly improved at posttreatment and follow-up, with no difference between treatment formats. CBT-TM sessions were, on average, nearly 10 min shorter, yet participant ratings of therapeutic alliance were similar to CBT-F2F. Conclusions Telemedicine delivery of CBT for insomnia is not inferior to face-to-face for insomnia severity and yields similar improvements on other sleep and daytime functioning outcomes. Further, telemedicine allows for more efficient treatment delivery while not compromising therapeutic alliance. Clinical Trial Registration Number NCT03293745

0469 Perceptions of an Education Only Control Group in the Osteoarthritis and Therapy for Sleep (OATS) Study: An Ongoing Statewide, Telephone-Delivered CBT for Insomnia (CBT-I) Randomized Trial

Introduction Comorbid osteoarthritis (OA) and insomnia is common in older adults. CBT-I is efficacious for improving sleep in older persons with OA but not widely accessible. We examined treatment process data from OATS, a large ongoing clinical trial of telephone-delivered CBT-I. Methods 327 Kaiser Permanente Washington members aged 60+ with OA, Insomnia Severity Index scores of 11+, and Brief Pain Inventory scores of 9+ were randomized to individual CBT-I vs. education only control (EOC). Six telephone sessions of CBT-I or EOC were offered over eight weeks. Participants rated their perceptions of treatment (credibility, acceptability, suitability, perceived effectiveness, adherence, and therapeutic relationship) on a 7-point Likert scale after session 1 and at 2-month post-test. Results Participants (mean age=70.2 years, 74.6% female) were randomized to the two treatment arms (CBT-I=163, EOC=164). Participants did not differ significantly across arms by age, gender, education, or by sleep, pain, or mood (depression, fatigue) outcome measures at baseline. CBT-I had significantly (p=.03) more white participants (90% CBT-I, 78% EOC). Study retention was 82% and 88% at post-test for CBT-I versus EOC, respectively. There was no difference in number of sessions attended (median=6). CBT-I sessions were somewhat longer than EOC (24.2 vs. 22.8 minutes; p=.005). Most participants in both groups at both time points gave high rankings (5+/7 points) on all six treatment perception ratings (CBT-I range: 75.9-99.3%; EOC range: 69.0-97.9%). Average summed treatment perception ratings improved between Session 1 and post-test for both conditions (mean=5.9 and 6.1, respectively, for CBT-I; mean=5.6 and 5.8, respectively, for EOC). Conclusion The OATS EOC group was credible and acceptable to participants, resulting in equivalently high levels of participation and retention compared to CBT-I. Findings suggest the ongoing trial has adequately controlled for nonspecific participant treatment effects that might confound interpretation of efficacy outcomes. Support This work was supported by PHS grant 5R01AG053221.