Automated VR therapy for improving positive self-beliefs and psychological well-being in young patients with psychosis: a proof of concept evaluation of Phoenix VR self-confidence therapy.

BACKGROUND: Low self-confidence in patients with psychosis is common. This can lead to higher symptom severity, withdrawal from activities, and low psychological well-being. There are effective psychological techniques to improve positive self-beliefs but these are seldom provided in psychosis services. With young people with lived experience of psychosis we developed a scalable automated VR therapy to enhance positive-self beliefs. AIMS: The aim was to conduct a proof of concept clinical test of whether the new VR self-confidence therapy (Phoenix) may increase positive self-beliefs and psychological well-being. METHOD: Twelve young patients with non-affective psychosis and with low levels of positive self-beliefs participated. Over 6 weeks, patients were provided with a stand-alone VR headset so that they could use Phoenix at home and were offered weekly psychologist meetings. The outcome measures were the Oxford Positive Self Scale (OxPos), Brief Core Schema Scale, and Warwick-Edinburgh Well-being Scale (WEMWBS). Satisfaction, adverse events and side-effects were assessed. RESULTS: Eleven patients provided outcome data. There were very large end-of-treatment improvements in positive self-beliefs (OxPos mean difference = 32.3; 95% CI: 17.3, 47.3; Cohen's d=3.0) and psychological well-being (WEMWBS mean difference = 11.2; 95% CI: 8.0, 14.3; Cohen's d=1.5). Patients rated the quality of the VR therapy as: excellent (n=9), good (n=2), fair (n=0), poor (n=0). An average of 5.3 (SD=1.4) appointments were attended. CONCLUSIONS: Uptake of the VR intervention was high, satisfaction was high, and side-effects extremely few. There were promising indications of large improvements in positive self-beliefs and psychological well-being. A randomized controlled clinical evaluation is warranted.

Randomised controlled trial of automated VR therapy to improve positive self-beliefs and psychological well-being in young people diagnosed with psychosis: a study protocol for the Phoenix VR self-confidence therapy trial.

INTRODUCTION: The confidence of young people diagnosed with psychosis is often low. Positive self-beliefs may be few and negative self-beliefs many. A sense of defeat and failure is common. Young people often withdraw from many aspects of everyday life. Psychological well-being is lowered. Psychological techniques can improve self-confidence, but a shortage of therapists means that very few patients ever receive such help. Virtual reality (VR) offers a potential route out of this impasse. By including a virtual coach, treatment can be automated. As such, delivery of effective therapy is no longer reliant on the availability of therapists. With young people with lived experience, we have developed a staff-assisted automated VR therapy to improve positive self-beliefs (Phoenix). The treatment is based on established cognitive behavioural therapy and positive psychology techniques. A case series indicates that this approach may lead to large improvements in positive self-beliefs and psychological well-being. We now aim to conduct the first randomised controlled evaluation of Phoenix VR. METHODS AND ANALYSIS: 80 patients with psychosis, aged between 16 and 30 years old and with low levels of positive self-beliefs, will be recruited from National Health Service (NHS) secondary care services. They will be randomised (1:1) to the Phoenix VR self-confidence therapy added to treatment as usual or treatment as usual. Assessments will be conducted at 0, 6 (post-treatment) and 12 weeks by a researcher blind to allocation. The primary outcome is positive self-beliefs at 6 weeks rated with the Oxford Positive Self Scale. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention to treat. ETHICS AND DISSEMINATION: The trial has received ethical approval from the NHS Health Research Authority (22/LO/0273). A key output will be a high-quality VR treatment for patients to improve self-confidence and psychological well-being. TRIAL REGISTRATION NUMBER: ISRCTN10250113.

Tibial cancellous bone changes in patients with knee osteoarthritis. A short-term longitudinal study using Fractal Signature Analysis.

OBJECTIVE: To quantify tibial cancellous bone changes over 24 months in patients with medial compartment knee osteoarthritis (OA) subdivided into those with slow or detectable joint space narrowing (JSN). METHOD: Digitised macroradiographs (4x) were obtained at baseline and 24 months from 40 patients (F:26) and subdivided by computerised measurement of minimum medial compartment joint space width (JSW) into those with slow JSN (<0.2 mm/year, n=66) or detectable JSN (>or=0.2 mm/year, n=14) and who had a mean (range) JSW at baseline of 3.89 (1.66-5.48) mm and 3.73 (2.49-5.74) mm, respectively. Fractal Signature Analysis measured longitudinal change in bone structure at four regions of interest (ROI): medial and lateral subchondral (Sc) and subarticular (Sa) regions. RESULTS: Mean (range) JSN for slow and detectable groups was 0.01 (-0.31-0.18) mm/year and 0.44 (0.20-1.01)mm/year, respectively. All ROIs in both groups had significant (P<0.05) decrease in fractal dimension (FD) at most trabecular sizes (vertical: 0.36-1.14 mm; horizontal: 0.36-1.14 mm, excluding the lateral Sa region) over 24 months. There were no between-group differences except at a few trabecular sizes within the Sa regions where the detectable JSN group had significantly (P<0.05) greater decrease in FD compared to the slow JSN group (medial: horizontal sizes 0.54-0.72 mm, 1.02-1.08 mm; lateral: vertical sizes 0.90-1.02 mm). CONCLUSION: Bone loss occurred in all knees with medial compartment OA. Decrease in FD of vertical and horizontal trabeculae was consistent with decrease in trabecular number associated with loss. The pattern of bone loss was similar in knees with slow and detectable JSN.

Cancellous bone differences between knees with early, definite and advanced joint space loss; a comparative quantitative macroradiographic study.

OBJECTIVE: To quantify differences in bone structure in the proximal tibia of patients with mild, definite and advanced osteoarthritis (OA) compared to healthy reference tibiae. DESIGN: Patients with medial compartment OA (n=110; F=70), mean+/-SD age 61.0+/-10.2 years, and non-OA reference subjects (n = 27; F = 10) mean+/-SD age 36.3+/-11.4 years had 4x macroradiographs digitised by laser scanner. Computer measurement of minimum medial joint space width (JSW) subdivided available OA knees into those with early (JSW > 3 mm, n=70), definite (JSW 1.5 mm, n = 52) and advanced OA (JSW 4.5 mm. Fractal Signature Analysis (FSA), a computerised image analysis technique, measured differences in cancellous bone structure between OA and non-OA tibiae at four regions of interest (ROIs). RESULTS: Compared to non-OA, FSA of vertical trabeculae increased significantly (P < 0.05) at most sizes (0.12-1.14 mm) in all OA subgroups and ROIs, with greatest increase occurring in the medial diseased compartment. Compared to early OA, FSA of vertical trabeculae increased significantly (P<0.05) at most sizes (0.36-1.14 mm) in subchondral and subarticular ROIs in definite and advanced OA. Compared to non-OA, FSA of horizontal trabeculae increased significantly (P < 0.05) at some small sizes in all ROIs and OA subgroups, and decreased significantly (P<0.05) at large sized horizontal trabeculae (0.60-1.14 mm) in the medial subarticular region in advanced OA. CONCLUSION: The increase in FSA (consistent with increased trabecular number associated with thinning and fenestration in regions of dense cancellous bone) of most vertical and some horizontal trabeculae confirms that cancellous bone within the proximal tibia of OA patients is osteoporotic.

Reproducibility of the semiflexed (metatarsophalangeal) radiographic knee position and automated measurements of medial tibiofemoral joint space width in a multicenter clinical trial of knee osteoarthritis.

OBJECTIVE: To determine the baseline and longitudinal consistency in reproducibility of the semiflexed metatarsophalangeal (MTP) position in repeat examinations of patients with knee osteoarthritis (OA) recruited for a multicenter clinical trial that terminated within one year (mean duration 0.81 yr), based on precise measurements both of minimum medial tibiofemoral compartment joint space width (JSW) and of tibial inter-rim distance. METHODS: Two technologists from 8 and one technologist from 14 clinical radiology units had received previous training in performing nonfluoroscopic semiflexed MTP knee examinations and in quality control criteria for film acceptance. Patients (N = 402; F = 269) were recruited from 58 rheumatology sites and referred to 22 centers, or "x-ray hubs," across North America. At baseline and at study exit, both knees were x-rayed twice on the same day. All films had quality control, and accepted films were digitized at the Central Radiographic Facility and transmitted to the Central Analysis Facility for computerized measurement of minimum medial compartment JSW and tibial inter-rim distance. JSW loss was calculated in the placebo group for the study period. RESULTS: The median SD of the difference in JSW between same-day test/retest film pairs was 0.9 mm for 767 baseline film pairs (knees with JSW > 0 mm), and 0.08 mm for 631 exit film pairs. JSW reproducibility was unaffected by subject's sex, age, and degree of JSW loss. Among all x-ray hubs, JSW reproducibility was excellent in 14 (SD < 0.1 mm), good in 6 (0.1 < SD < 0.2 mm), and moderate in 2 hubs (0.2 < SD < 0.3 mm). No statistical difference was found in technologists' ability either in positioning OA knees or in their test/retest reproducibility in repositioning joints at baseline and at study exit. JSW did not alter significantly during the study period. CONCLUSION: The protocol for the semiflexed MTP knee position provides a highly reproducible method for anatomically repositioning the knee and for measuring JSW, necessary for OA clinical trials. It is a simple method that can be employed readily at clinical radiology units, as shown by the similarity in JSW precision between x-ray hubs. The results from this large dataset show that throughout the study precise measurements of JSW were obtained from same-day repeat radiographs, findings that together with previous single-center studies confirm the reliability of this method for clinical trial use.

Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the safety and efficacy of long-term intraarticular (IA) steroid injections for knee pain related to osteoarthritis (OA). METHODS: In a randomized, double-blind trial, 68 patients with OA of the knee received IA injections of triamcinolone acetonide 40 mg (34 patients) or saline (34 patients) into the study knee every 3 months for up to 2 years. The primary outcome variable was radiologic progression of joint space narrowing of the injected knee after 2 years. Measurements of minimum joint space width were performed by an automated computerized method on standardized fluoroscopically guided radiographs taken with the patient standing and with the knee in a semiflexed position. The clinical efficacy measure of primary interest was the pain subscale from the Western Ontario and McMaster Universities OA Index (WOMAC). Efficacy measures of secondary interest were the total score on the WOMAC, physician's global assessment, patient's global assessment, patient's assessment of pain, range of motion (ROM) of the affected knee, and 50-foot walking time. Clinical symptoms were assessed just before each injection. RESULTS: At the 1-year and 2-year followup evaluations, no difference was noted between the two treatment groups with respect to loss of joint space over time. The steroid-injected knees showed a trend toward greater symptom improvement, especially at 1 year, for the WOMAC pain subscale, night pain, and ROM values (P = 0.05) compared with the saline-injected knees. Using area under the curve analyses, knee pain and stiffness were significantly improved throughout the 2-year study by repeated injections of triamcinolone acetonide, but not saline (P < 0.05). CONCLUSION: Our findings support the long-term safety of IA steroid injections for patients with symptomatic knee OA. No deleterious effects of the long-term administration of IA steroids on the anatomical structure of the knee were noted. Moreover, long-term treatment of knee OA with repeated steroid injections appears to be clinically effective for the relief of symptoms of the disease.

X-ray technologists' reproducibility from automated measurements of the medial tibiofemoral joint space width in knee osteoarthritis for a multicenter, multinational clinical trial.

OBJECTIVE: To determine the reproducibility of x-ray technologists, 26 in North America (NA), 24 in Europe (EU), in reliably repositioning patient's osteoarthritic (OA) knees, from computerized measurements of minimum joint space width (JSW) and reproducibility in joint repositioning, during their training for the clinical trial. METHODS: Technologists from 12 NA and 12 EU clinical radiology units received identical training, at one site on each continent, in performing the fluoroscopically assisted semiflexed knee examination and in quality control criteria (QCC) for film acceptance. Subjects recruited were 129 in NA and 70 in EU, with both knees radiographed for some subjects. Each technologist radiographed 5 OA knees and repeated the process on the same knees 2 to 7 days later. Minimum medial JSW was measured at a single center on digitized images with computer software that corrected for radiographic magnification. Technologists' reproducibility in joint repositioning and JSW measurement was determined from the difference between test and retest. RESULTS: In all, only 3/50 technologists failed qualification criteria with a repeat-film JSW difference > 0.50 mm. The mean, standard deviation (SD) of the difference in JSW between test/retest for 146 NA film-pairs of -0.020 (0.16) mm was not statistically different from that in 120 EU film-pairs: -0.001 (0.18) mm. In NA and EU 45% of examinations achieved high quality, i.e., JSW difference between repeat films < 0.1 mm, and 92% achieved excellent to good quality with a difference between repeat films < 0.3 mm. NA and EU technologists' reproducibility was unaffected by subject's sex, age, and degree of JSW loss. Reproducibility in joint reposition for all technologists was excellent. CONCLUSION: Between-continent precision of JSW measurements from all accepted pairs of semiflexed views was excellent to very good and similar to the high technical quality achieved in the authors' original report. The value of training incorporating both test/retest radiographs and film QCC is essential for the high technical quality required for multinational clinical trials.