Controlled Pilot Trial Research Articles

The Effects of Medium-Term Intake of Hydrogen-Rich Water on Sperm Quality Biomarkers in Normospermic and Oligospermic Men: A Randomized Controlled Pilot Trial

The main aim of this randomized controlled pilot trial was to evaluate the effects of hydrogen-rich water on spermiogram parameters in normospermic and oligospermic men. As many as 12 healthy young men (age 29.1 ± 5.9 years; n = 6 normospermic; n = 6 oligospermic) volunteered. Participants were allocated in a double-blind manner to receive 1 L of hydrogen-rich water per day or 1 L of tap water fortified with magnesium for 8 weeks. Following hydrogen-rich water supplementation, sperm concentration and morphology tended to increase by 12.4 million per milliliter (95% CI; –31.8 to 56.6), and live cells increased by 3.8% (95% CI; –12.5 to 20.1), respectively (P ≤ 0.30). A significant difference between the two interventions was found in sperm vitality (P = 0.03), with hydrogen-rich water being superior to the placebo in terms of an increase in the number of live sperm cells. Subgroup analyses revealed no significant differences between interventions in sperm viability outcomes in oligospermic men (P > 0.05). However, sperm count increased by over 20 million in two of the three oligospermic men (66.7%) receiving hydrogen-rich water, while no oligospermic men in the placebo group increased sperm concentration to euspermic levels (P < 0.01). These preliminary findings suggest hydrogen-rich water is an effective intervention for improving some aspects of male subfertility; further large-sample trials are warranted to corroborate our results.

Advanced heart failure patients and family caregivers health and function: randomised controlled pilot trial of online dignity therapy

ObjectivesThis research investigated the effectiveness of the caregiver-mediated online dignity therapy in enhancing dyadic health and family function.MethodsHeart failure (HF) family dyads were recruited between May and December 2021 from...

Oral Sequelae after Head and Neck Radiotherapy: RCT Comparing 3D-Printed Tissue Retraction Devices with Conventional Dental Splints.

To evaluate oral sequelae after head and neck radiotherapy (RT) when using two different types of intraoral appliances. Thermoplastic dental splints (active control) protect against backscattered radiation from dental structures. Semi-individualized, 3D-printed tissue retraction devices (TRDs, study group) additionally spare healthy tissue from irradiation. A total of 29 patients with head and neck cancer were enrolled in a randomized controlled pilot trial and allocated to receive TRDs (n = 15) or conventional splints (n = 14). Saliva quality and quantity (Saliva-Check, GC), taste perception (Taste strips, Burghart-Messtechnik), and oral disability (JFLS-8, OHIP-14, maximum mouth opening) were recorded before and 3 months after RT start. Radiotherapy target volume, modality, total dose, fractionation, and imaging guidance were case-dependent. To evaluate intra-group developments between baseline and follow-up, nonparametric Wilcoxon tests were performed. Mann-Whitney-U tests were applied for inter-group comparisons. At follow-up, taste perception was unimpaired (median difference in the total score; TRDs: 0, control: 0). No significant changes were found regarding oral disability. Saliva quantity (stimulated flow) was significantly reduced with conventional splints (median -4 mL, p = 0.016), while it decreased insignificantly with TRDs (median -2 mL, p = 0.07). Follow-up was attended by 9/15 study group participants (control 13/14). Inter-group comparisons showed no significant differences but a tendency towards a better outcome for disability and saliva quality in the intervention group. Due to the small cohort size and the heterogeneity of the sample, the results must be interpreted with reservation. Further research must confirm the positive trends of TRD application. Negative side-effects of TRD application seem improbable.

Intraoperative carbetocin to decrease blood loss during hysteroscopic myomectomy: a randomized controlled pilot trial.

intraoperative carbetocin to decrease blood loss during hysteroscopic myomectomy: a randomized controlled pilot trial.

Effects of left anodal transcranial direct current stimulation on hypothalamic–pituitary–adrenal axis activity in depression: a randomized controlled pilot trial

The main objective of this study was to evaluate the effect of left anodal transcranial direct current stimulation (tDCS) on hypothalamic–pituitary–adrenal axis (HPAA) activity in individuals with depression. We conducted a 3-week, randomized, triple-blind pilot trial with 47 participants (dropout rate: 14.89%) randomly assigned to either the tDCS or control group (sham stimulation). Salivary cortisol was used as an HPAA activity marker since cortisol is the effector hormone of the HPAA. The primary outcome was the effect of tDCS on the diurnal cortisol pattern (DCP and area under the curve with respect to ground -AUCg-). Secondary outcomes included tDCS effects on cortisol awakening response (CAR) and cortisol decline (CD), as well as the variation of cortisol concentrations between the initiation of tDCS and 2 weeks later. Intention-to-treat and per-protocol analyses were conducted. Our primary outcome showed an absent effect of tDCS on DCP and AUCg. Additionally, tDCS had an absent effect on CAR, CD, and cortisol concentration variation before-after stimulation. Our pilot study suggests that anodal tDCS showed an absent effect on HPAA activity in individuals with depression. More studies are needed to confirm these findings.

A smartphone-based serious game for depressive symptoms: Protocol for a pilot randomized controlled trial

BackgroundDepression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms. MethodsThis randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses. DiscussionThe study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.

Physiological and Psychological Response to Acute Mental Stress in Female Patients Affected by Chronic Pulmonary Arterial Hypertension: An Explorative Controlled Pilot Trial.

Little is known about physiological and psychological responses to mental stress in stable patients affected by pulmonary arterial hypertension (PAH). The current explorative controlled pilot study was conducted to investigate whether heart rate (HR) and perceived stress would differ during standardized mental stress testing in PAH patients compared to healthy subjects. Correlation analysis between HR, perceived stress, participants' psychological status and performance on the mental stress task was also performed. The study included 13 female PAH patients (average age: 44.38 ± 10.88 years; average education: 14 ± 3.07 years; mean duration of illness: 9.15 ± 5.37 years) and 13 female controls similar in age (mean age: 47.85 ± 6.36 years) and education (15.92 ± 1.55 years). Participants performed a standardized 9 min mental stress test (computer based, adaptive math task). HR and perceived stress during the task were compared to resting baseline and correlated with psychological state and task performance. Both HR and perceived stress significantly increased during mental stress in a similar way in both groups. A significant correlation was found between HR and perceived stress. Our data show that moderate mental stress has a comparable effect on HR and perceived stress increase in stable PAH patients and control subjects.

Bovine colostrum as a fortifier to human milk in very preterm infants – A randomized controlled trial (FortiColos)

Human milk for very preterm infants need fortification for optimal growth and development but the optimal fortification product remains to be identified. To investigate feasibility, safety and preliminary efficacy on growth and blood biochemistry when using intact bovine colostrum (BC) as a fortifier to human milk in very preterm infants. In an open-label, multicenter, randomized controlled pilot trial (infants 26-31 weeks' gestation), mother's own milk or donor human milk was fortified with powdered BC (n=115) or a conventional fortifier (CF, bovine-milk-based, n=117) until 35 weeks' postmenstrual age. Fortifiers and additional micronutrients were added to human milk according to local guidelines to achieve optimal growth (additional protein up to+1.4g protein/100mL human milk). Anthropometry was recorded weekly. Clinical morbidities including necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) were recorded. Clinical biochemistry included plasma amino acid (AA) levels to assess protein metabolic responses to the new fortifier. A total of 232 infants, gestational age (GA) 28.5±1.4 (weeks+days), fulfilled inclusion criteria. Birthweight, GA and delta Z scores from birth to end of intervention on weight, length or head circumference did not differ between groups, nor between the subgroups of small for gestational age infants. Likewise, incidence of NEC (BC: 3/115 vs. CF: 5/117, p=0.72, unadjusted values), LOS (BC: 23/113 vs. CF: 14/116, p=0.08) and other morbidities did not differ. BC infants received more protein than CF infants (+10%, p<0.05) and showed several elevated AA levels (+10-40%, p<0.05). Infants fortified with BC showed similar growth but received more protein and showed a moderate increase in plasma AA-levels, compared with CF. Adjustments in protein composition and micronutrients in BC-based fortifiers may be required to fully suit the needs for very preterm infants.

MyKidneyCoach, Patient Activation, and Clinical Outcomes in Diverse Kidney Transplant Recipients: A Randomized Control Pilot Trial.

This was a randomized, age-stratified, parallel-group, attention-control, pilot study in post-KT patients. Participants were randomized into the attention-control with access to MyKidneyCoach for education and self-management (n = 9) or the intervention with additional tailored nurse coaching (n = 7). Feasibility, acceptability, and clinical outcomes were assessed. The acceptability of MyKidneyCoach by System Usability Scale was 67.5 (95% confidence interval [CI], 59.1-75.9). Completion rates based on actively using MyKidneyCoach were 81% (95% CI, 57%-93%) and study retention rate of 73%. Patient activation measure significantly increased overall by a mean of 11 points (95% CI, 3.2-18.8). Additionally, Black patients (n = 7) had higher nutrition self-efficacy scores of 80.5 (95% CI, 74.4-86.7) compared with 75.6 (95% CI, 71.1-80.1) in non-Black patients (n = 9) but lower patient activation measure scores of 69.3 (95% CI, 56.3-82.3) compared with 71.8 (95% CI, 62.5-81) in non-Black patients after 3 mo. MyKidneyCoach was easy to use and readily accepted with low attrition, and improvements were demonstrated in patient-reported outcomes. Both Black and non-Black participants using MyKidneyCoach showed improvement in self-management competencies; thus, this intervention may help reduce healthcare inequities in KT.

Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study.

Hand impairment is a common consequence of stroke, resulting in long-term disability and reduced quality of life. Recovery may be augmented through self-directed therapy activities at home, complemented by the use of rehabilitation devices such as peripheral sensory stimulation. The objective of this study was to determine the effect of adherence to self-directed therapy and the use of TheraBracelet (subsensory random-frequency vibratory stimulation) on hand function for stroke survivors. In a double-blind, randomized controlled pilot trial, 12 chronic stroke survivors were assigned to a treatment or control group (n = 6/group). All participants were instructed to perform 200 repetitions of therapeutic hand tasks 5 days/week while wearing a wrist-worn device 8 hours/day for 4 weeks. The treatment group received TheraBracelet vibration from the device, while the control group received no vibration. Home task repetition adherence and device wear logs, as well as hand function assessment (Stroke Impact Scale Hand domain), were obtained weekly. Repetition adherence was comparable between groups but varied among participants. Participants wore the device to a greater extent than adhering to completing repetitions. A linear mixed model analysis showed a significant interaction between repetition and group (p = 0.01), with greater adherence resulting in greater hand function change for the treatment group (r = 0.94; R 2 = 0.88), but not for the control group. Secondary analysis revealed that repetition adherence was greater for those with lower motor capacity and greater self-efficacy at baseline. This pilot study suggests that adherence to self-directed therapy at home combined with subsensory stimulation may affect recovery outcomes in stroke survivors. This trial is registered with NCT04026399.

Rationale and Design of a Randomized Controlled Pilot Trial to Assess Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients with Acute Myocardial Infarction: The RETRIEVE-AMI Study

BackgroundST-elevation myocardial infarction (STEMI) is typically caused by thrombotic occlusion of a coronary artery with subsequent hypoperfusion and myocardial necrosis. In approximately half of patients with STEMI, despite successful restoration of epicardial coronary patency, downstream myocardium perfusion remains impeded. Coronary microvascular injury is one of the key mechanisms behind suboptimal myocardial perfusion and it is primarily, yet not exclusively, related to distal embolization of atherothrombotic material following recanalization of the culprit artery. Routine manual thrombus-aspiration has failed to show clinical efficacy in this scenario. This could be related with limitations in technology adopted as well as patients' selection. To this end, we set out to explore the efficacy and safety of stent retriever-assisted thrombectomy based on clot-removal device routinely used in stroke intervention. Study design and objectivesThe stent RETRIEVEr thrombectomy for thrombus burden reduction in patients with Acute Myocardial Infarction (RETRIEVE-AMI) study has been designed to establish whether stent retriever-based thrombectomy is safe and more efficacious in thrombus modification than the current standard of care: manual thrombus aspiration or stenting. The RETRIEVE-AMI trial will enrol 81 participants admitted for primary PCI for inferior STEMI. Participants will be 1:1:1 randomised to receive either standalone PCI, thrombus aspiration and PCI, or retriever-based thrombectomy and PCI. Change in thrombus burden will be assessed via optical coherence tomography imaging. A telephone follow-up at 6 months will be arranged. ConclusionsIt is anticipated by the investigators that stent retriever thrombectomy will more effectively reduce the thrombotic burden compared to current standard of care whilst being clinically safe.

AGESMind clinical trial: SocialMIND® results at 16 weeks

IntroductionEarly intervention on a first psychotic episode is fundamental for a more favorable prognosis, and it usually combines pharmacological treatment, which mainly affects positive psychotic symptoms, with interventions that can improve the rest of the symptoms and associated problems such as deterioration in social functioning (Harvey &amp; Penn, 2010; Fusar-Poli, McGorry &amp; Kane, 2017). While Mindfulness is gaining more and more prominence in the field of psychotherapy (Chan et al., 2019; Cillesen et al., 2019), social cognition and social functioning are being researched as key targets on which to intervene after a first psychotic episode (Green, Horan &amp; Lee, 2015).SocialMIND® is a mindfulness-based social cognition training tailor-made to improve social functioning in people who have suffered a first psychotic episode within the last five years. It is currently being compared with a group Psychoeducational Multicomponent Intervention (PMI) in a Randomized Controlled Trial (RCT) (Mediavilla et al., 2019). Both group psychotherapies include 17 sessions delivered over a 9 month period: 8 weekly sessions, 4 biweekly sessions and 5 monthly sessions.The results of SocialMIND® at 8 weeks showed improvements in social cognition and social functioning, specifically on affective social cognition and self-care (Mediavilla et al., 2021).ObjectivesTo evaluate the efficacy of SocialMIND® in improving social functioning, measured by the Personal and Social Functioning (PSP) scale 16 weeks after starting the intervention, in people who have suffered a first psychotic episode in the last 5 years.MethodsRandomized, controlled pilot trial (use of a psychoeducational multicomponent intervention or PMI as active comparator) of two parallel groups (SocialMIND® and PMI) with a 1:1 ratio using a blind evaluator.ResultsNo statistically significant differences were found in the social functioning variable between the two treatment arms. Intragroup differences are observed in other secondary variables studied (social cognition) 16 weeks after starting the interventions.ConclusionsSocialMIND® has not been shown to be more effective than a PMI in improving social functioning at 16 weeks after starting the intervention in people who have suffered a first psychotic episode in the five years prior to being included in the study.Disclosure of InterestNone Declared

Adjunctive Therapy of Text4Support for Treatment-Resistant Depression Patients Receiving Repetitive Transcranial Magnetic Stimulation. A Multicenter Randomized Controlled Pilot Trial

IntroductionDespite several treatment strategies for treatment-resistant depression (TRD) exist, including the use of repetitive transcranial magnetic stimulation (rTMS), new therapeutic options are being introduced. Text4Support is a form of cognitive behavior therapy that allows patients with depression to receive daily supportive text messages that seek to correct or alter negative thought patterns through positive reinforcement. Text4Support is deemed a useful augmentation treatment strategy for patients with TRD. It is however currently unknown if adding the Text4Support intervention will enhance patients with TRD’s response to rTMS treatmentsObjectivesThis study aims to assess the initial comparative clinical effectiveness of rTMS when used with and without the Text4Support program as an innovative patient-centered intervention for the management of participants diagnosed with TRD.MethodsThis study is a multicentered prospective, parallel-design, two-arm, rater-blinded randomized controlled pilot trial. In total, 200 participants diagnosed with TRD will be randomized to one of two treatment arms (rTMS alone and rTMS with Text4Support). Participants in each arm will be made to complete evaluation measures at baseline, 1,3, and 6 months. The primary outcome measure will be the mean change to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses.ResultsThe result of the study is expected to be available 18 months after the start of recruitment. We hypothesize that participants enrolled in the rTMS plus Text4Support intervention will achieve superior outcomes compared with participants enrolled in the rTMS treatment alone.ConclusionsThe concomitant application of the combination of these two treatment techniques has not been investigated previously. Therefore, we hope that this project will provide a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities.Disclosure of InterestNone Declared

Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial.

Some patients with neuralgia of cranial nerves with otherwise therapy-refractory pain respond to invasive therapy with local anesthetics. Unfortunately, pain regularly relapses despite multimodal pain management. Transcranial direct current stimulation (tDCS) may prolong pain response due to neuro-modulatory effects. This controlled clinical pilot trial randomized patients to receive anodal, cathodal or sham-tDCS stimulation prior to local anesthetic infiltration. Pain attenuation, quality-of-life and side effects were assessed and compared with historic controls to estimate effects of tDCS stimulation setting. Altogether, 17 patients were randomized into three groups with different stimulation protocols. Relative reduction of pain intensity in per protocol treated patients were median 73%, 50% and 69% in anodal, cathodal and sham group, respectively (p = 0.726). Compared with a historic control group, a lower rate of responders with 50% reduction of pain intensity indicates probable placebo effects (OR 3.41 stimulation vs. non-stimulation setting, NNT 3.63). 76.9% (n = 10) of tDCS patients reported mild side-effects. Of all initially included 17 patients, 23.5% (n = 4) withdrew their study participation with highest proportion in the cathodal group (n = 3). A sample size calculation for a confirmatory trial revealed 120 patients using conservative estimations. This pilot trial does not support series of anodal tDCS as neuro-modulatory treatment to enhance pain alleviation of local anesthetic infiltration series. Notably, results may indicate placebo effects of tDCS settings. Feasibility of studies in this population was limited due to relevant drop-out rates. Anodal tDCS warrants further confirmation as neuro-modulatory pain treatment option.

Effectiveness of an Unguided Online Intervention for Sexual Pleasure in Women: A Randomized Controlled Pilot Study

The importance of sexual pleasure as a factor promoting sexual and public health is increasingly recognized. Nevertheless, hardly any theory-based and empirically tested interventions exist for fostering sexual pleasure. Consequently, we developed an unguided online intervention called PleaSure to promote sexual pleasure in women. In a randomized controlled pilot trial with a mixed-method design, we evaluated the effectiveness of PleaSure by comparing the intervention group to a waitlist control group in pre–post measurements over 4 weeks. With 657 participants (Mage = 31.46, SDage = 8.78), we evaluated an index of sexual pleasure and five facets: sensual pleasure, pleasure-related mastery, pleasure-related validation, interaction pleasure, and bonding pleasure. The results show that the online intervention primarily strengthened the intrapersonal domain of sexual pleasure by increasing pleasure-related mastery. Neither the other facets nor the index was significantly influenced by the intervention. Although the effects of the quantitative data are small, the qualitative data support overall positive effects on participants’ sexual experience. We discuss the content of the intervention and the methods used. Our pilot study suggests that sexual pleasure can be promoted but that major improvements are needed to the intervention’s content and design to do so effectively. Therefore, future studies are encouraged to further develop and implement such resource-efficient interventions in clinical and non-clinical samples to better understand the importance of sexual pleasure to sexual health.

Telehealth-supervised exercise in systemic lupus erythematosus: A pilot study.

To explore the feasibility and effectiveness of telehealth-supervised exercise for adults with Systemic lupus erythematosus (SLE). This was a non-randomised controlled pilot trial comparing telehealth-supervised exercise (8weeks, 2days/week, 45min, moderate intensity) plus usual care with usual care alone. Mixed methods were used to assess change in fatigue (FACIT-fatigue), quality of life (SF36), resting fatigue and pain (11-point scale), lower body strength (five-time sit-to-stand) and endurance (30s sit-to-stand), upper body endurance (30s arm curl), aerobic capacity (2min step test), and experience (survey and interviews). Group comparison was performed statistically using a two-sample T-test or Mann-Whitney U-test. Where known, we used MCID or MCII, or assumed a change of 10%, to determine clinically meaningful change within groups over time. Interviews were analysed using reflexive thematic analysis. Fifteen female adults with SLE were included (control group n = 7, exercise group n = 8). Statistically significant differences between groups, in favour of the exercise intervention, were noted for SF36 domain emotional well-being (p = 0.048) and resting fatigue (p = 0.012). There were clinically meaningful improvements over time for FACIT-fatigue (+6.3 ± 8.3, MCID >5.9), SF36 domains physical role functioning (+30%), emotional role functioning (+55%), energy/fatigue (+26%), emotional well-being (+19%), social functioning (+30%), resting pain (-32%), and upper body endurance (+23%) within the exercise group. Exercise attendance was high (98%, 110/112 sessions); participants strongly agreed (n = 5/7, 71%) or agreed (n = 2/7, 29%) they would do telehealth-supervised exercise again and were satisfied with the experience. Four themes emerged: (1) ease and efficiency of exercising from home, (2) value of live exercise instruction, (3) challenges of exercising at home, and (4) continuation of telehealth-supervised exercise sessions. Key findings from this mixed-method investigation suggest that telehealth-supervised exercise was feasible for, and well-accepted by, adults with SLE and resulted in some modest health improvements. We recommend a follow-up RCT with more SLE participants.

A supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial

IntroductionAs a high symptom burden chronic condition, endometriosis is associated with diminished quality of life (QoL) and psychological distress. The EndoSMS text message intervention was developed to inform and support individuals living with endometriosis. The primary aim of this study is to assess the acceptability, feasibility and preliminary efficacy of EndoSMS, to improve endometriosis-specific QoL and reduce psychological distress in a randomised controlled trial, compared with care as usual. We will additionally assess the impact of EndoSMS on self-efficacy for managing endometriosis. MethodologyA two-arm parallel pilot randomised controlled trial with waitlist control was conducted. Baseline assessments included QoL, psychological distress, self-efficacy, demographic and medical variables. Following baseline survey completion, participants were randomised to either the Intervention (EndoSMS: 3-months of text messaging) or Control condition. At 3-month follow-up, all participants completed an online survey reassessing outcomes, and Intervention participants provided quantitative and qualitative user feedback on EndoSMS. ResultsData collection commenced on 18 November 2021 and was completed on 30 March 2022. Descriptive statistics will be used to analyse feasibility and acceptability of the intervention. Preliminary efficacy analyses will be conducted using linear mixed models for QoL, psychological distress and self-efficacy outcomes. Subgroup analyses will also be conducted for typically underserved populations (e.g., rural/regional). ConclusionThis pilot will provide acceptability, feasibility and preliminary efficacy evidence for the impact of a supportive text messaging program for endometriosis. It will contribute to understanding how to optimally support individuals in living with and managing their endometriosis. Trial RegistrationAustralian New Zealand Clinical Trials Registry.

The evaluation of a brief ICBT program with therapist support for individuals with gambling problems in the context of a gambling helpline: a randomized pilot trial

Background and aimsGambling helplines are a natural way of first contact for individuals with gambling problems. However, few studies have evaluated the feasibility and effectiveness of brief interventions in a gambling helpline. To reduce this knowledge gap, this study evaluated the feasibility of an online cognitive behavioral therapy (ICBT) program in the context of a gambling helpline as a first step towards a full-scale RCT.DesignThis is a two-group parallel randomized controlled pilot trial where the participants were randomized to either a brief four-module ICBT program (n = 22) or a control group (n = 21). Participants were followed up weekly during the intervention, post intervention, and 6 weeks upon completion of intervention.ParticipantsA total of 43 self-identified individuals with gambling problems (scoring 3 or more on the Problem Gambling Severity Index) were recruited via the Swedish national gambling helpline, 59% females, mean age 43.7 years.MeasurementsFeasibility of the procedure and intervention (i.e., recruitment pace, attrition, program engagement, and satisfaction) were the primary outcomes; treatment effect (net gambling losses) was the secondary outcome.ResultsApproximately 2 participants per week were randomized, and retention was low, with 47% lost to follow-up at the 6-week follow-up time-point. Most participants engaged in the online modules (86%) and rated their overall satisfaction with the program as high (7.5 out of 10). Both groups decreased their weekly gambling losses at both follow-up time-points, but the between-group comparisons were inconclusive.ConclusionIt is not advisable to conduct a full-scale RCT based on the results from this pilot study. Future studies in a gambling helpline should consider interventions that are more suited to be incorporated in a gambling helpline and identify ways to increase participant engagement.Trial registrationThe study was retrospectively registered on ClinicalTrials.gov (ID: NCT04609007, 29/10/2020).

Apparent Lack of Benefit of Combining Repetitive Transcranial Magnetic Stimulation with Internet-Delivered Cognitive Behavior Therapy for the Treatment of Resistant Depression: Patient-Centered Randomized Controlled Pilot Trial.

Background: Treatment-resistant depression (TRD) is considered one of the major clinical challenges in the field of psychiatry. An estimated 44% of patients with major depressive disorder (MDD) do not respond to two consecutive antidepressant therapies, and 33% do not respond to up to four antidepressants. Over 15% of all patients with MDD remain refractory to any treatment intervention. rTMS is considered a treatment option for patients with TRD. Likewise, iCBT is evidence-based, symptom-focused psychotherapy recommended for the treatment of TRD. Objective: This study aimed to evaluate the initial comparative clinical effectiveness of rTMS treatment with and without iCBT as an innovative intervention for the treatment of participants diagnosed with TRD. Methods: This study is a prospective two-arm randomized controlled trial. Overall, 78 participants diagnosed with TRD were randomized to one of two treatment interventions: rTMS sessions alone and rTMS sessions plus iCBT. Participants in each group were made to complete evaluation measures at baseline, and 6 weeks (discharge) from treatment. The primary outcome measure was baseline to six weeks change in mean score for the 17-item Hamilton depression rating scale (HAMD-17). Secondary outcomes included mean baseline to six-week changes in the Columbia suicide severity rating scale (CSSRS) for the rate of suicidal ideations, the QIDS-SR16 for subjective depression, and the EQ-5D-5L to assess the quality of health in participants. Results: A majority of the participants were females 50 (64.1%), aged ≥ 40 39 (50.0%), and had college/university education 54 (73.0%). After adjusting for the baseline scores, the study failed to find a significant difference in the changes in mean scores for participants from baseline to six weeks between the two interventions under study on the HAMD-17 scale: F (1, 53) = 0.15, p = 0.70, partial eta squared = 0.003, CSSRS; F (1, 56) = 0.04 p = 0.85, partial eta squared = 0.001, QIDS-SR16 scale; F (1, 53) = 0.04 p = 0.61, partial eta squared = 0.005, and EQ-5D-VAS; F (1, 51) = 0.46 p = 0.50, and partial eta squared = 0.009. However, there was a significant reduction in means scores at week six compared to baseline scores for the combined study population on the HAMD-17 scale (42%), CSSRS (41%), QIDS-SR16 scale (35%), and EQ-VAS scale (62%). Conclusion: This study did not find that combined treatment of TRD with rTMS + iCBT (unguided) was superior to treatment with rTMS alone. Our findings do not support the use of combined treatment of rTMS + iCBT for the management of TRD disorders.

Virtual reality exposure therapy for reducing social anxiety in stuttering: A randomized controlled pilot trial.

We report on findings from the first randomized controlled pilot trial of virtual reality exposure therapy (VRET) developed specifically for reducing social anxiety associated with stuttering. People who stutter with heightened social anxiety were recruited from online adverts and randomly allocated to receive VRET (n = 13) or be put on a waitlist (n = 12). Treatment was delivered remotely using a smartphone-based VR headset. It consisted of three weekly sessions, each comprising both performative and interactive exposure exercises, and was guided by a virtual therapist. Multilevel model analyses failed to demonstrate the effectiveness of VRET at reducing social anxiety between pre- and post-treatment. We found similar results for fear of negative evaluation, negative thoughts associated with stuttering, and stuttering characteristics. However, VRET was associated with reduced social anxiety between post-treatment and one-month follow-up. These pilot findings suggest that our current VRET protocol may not be effective at reducing social anxiety amongst people who stutter, though might be capable of supporting longer-term change. Future VRET protocols targeting stuttering-related social anxiety should be explored with larger samples. The results from this pilot trial provide a solid basis for further design improvements and for future research to explore appropriate techniques for widening access to social anxiety treatments in stuttering.