scholarly journals Affect-Focused Psychodynamic Internet-Based Therapy for Adolescent Depression: Randomized Controlled Trial

10.2196/18047 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e18047 ◽  
Author(s):  
Karin Lindqvist ◽  
Jakob Mechler ◽  
Per Carlbring ◽  
Peter Lilliengren ◽  
Fredrik Falkenström ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
Adolescent Depression ◽  
Primary Outcome ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Self Compassion ◽  
Randomised Controlled

Background Adolescent depression is one of the largest health issues in the world and there is a pressing need for effective and accessible treatments. Objective This trial examines whether affect-focused internet-based psychodynamic therapy (IPDT) with therapist support is more effective than an internet-based supportive control condition on reducing depression in adolescents. Methods The trial included 76 adolescents (61/76, 80% female; mean age 16.6 years), self-referred via an open access website and fulfilling criteria for major depressive disorder. Adolescents were randomized to 8 weeks of IPDT (38/76, 50%) or supportive control (38/76, 50%). The primary outcome was self-reported depressive symptoms, measured with the Quick Inventory of Depressive Symptomatology for Adolescents (QIDS-A17-SR). Secondary outcomes were anxiety severity, emotion regulation, self-compassion, and an additional depression measure. Assessments were made at baseline, postassessment, and at 6 months follow-up, in addition to weekly assessments of the primary outcome measure as well as emotion regulation during treatment. Results IPDT was significantly more effective than the control condition in reducing depression (d=0.82, P=.01), the result of which was corroborated by the second depression measure (d=0.80, P<.001). IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003). Significantly more patients in the IPDT group compared to the control group met criteria for response (56% vs 21%, respectively) and remission (35% vs 8%, respectively). Results on depression and anxiety symptoms were stable at 6 months follow-up. On average, participants completed 5.8 (SD 2.4) of the 8 modules. Conclusions IPDT may be an effective intervention to reduce adolescent depression. Further research is needed, including comparisons with other treatments. Trial Registration International Standard Randomised Controlled Trial Number (ISRCTN) 16206254; http://www.isrctn.com/ISRCTN16206254

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Testing the Efficacy of ‘Unlearning’, a Mindfulness and Compassion-Based Programme for Cultivating Nonviolence in Teenagers: A Randomised Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Irene Delgado-Suárez ◽  
Yolanda López-del-Hoyo ◽  
Javier García-Campayo ◽  
Adrián Pérez-Aranda ◽  
Marta Modrego-Alarcón ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Multiple Comparisons ◽  
Post Treatment ◽  
Control Group ◽  
Self Compassion ◽  
Baseline Levels ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Most programmes developed to reduce aggressive attitudes among teenagers are based on cultivating nonviolence, a construct that has been related to compassion and, more indirectly, mindfulness. This study aims at testing the efficacy of ‘Unlearning’, a mindfulness and compassion-based programme, for reducing aggressive attitudes in adolescents.Method: A sample of 164 students from three high schools in Zaragoza (Spain) participated in the study. They were randomly assigned to (1) ‘Unlearning’, or (2) relaxation programme. Three assessment points were established: baseline, post-treatment and a 4-month follow-up. The outcome variables were the subscales of the ‘Attitudes Toward Social Aggression Scale’. Mindfulness and compassion were assessed as secondary outcomes.Results: ‘Unlearning’ did not produce changes in the primary outcomes, but significant effects were observed post-treatment in self-compassion; and in the follow-up, in self-compassion and mindfulness. The control group did not experience any change post-treatment, but a significant effect in mindfulness was observed in the follow-up. The intergroup analyses indicated that ‘Unlearning’ improved self-compassion, both post-treatment (t = −2.48, p = 0.014) and after 4-months (t = −2.03, p = 0.044), although these results were not statistically significant after correcting for multiple comparisons.Conclusion: ‘Unlearning’ did not produce significant reductions in aggressive attitudes compared to the control group. The low baseline levels may have hindered the efficacy of the interventions. ‘Unlearning’ showed potential to improve self-compassion, which is related to nonviolence, and this may have positive implications for the adolescents. Future interventions should include teachers and families to enhance the effectiveness of the programmes.

scholarly journals Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

scholarly journals The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Single Incision ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Female Stress Urinary Incontinence ◽  
Midurethral Slings ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Economic evaluation of a crisis resolution service: A randomised controlled trial

2009 ◽  
Vol 18 (1) ◽  
pp. 54-58 ◽  
Author(s):  
Paul McCrone ◽  
Sonia Johnson ◽  
Fiona Nolan ◽  
Stephen Pilling ◽  
Andrew Sandor ◽  
...  
Keyword(s):  
Mental Health ◽  
Service Use ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cost Effective ◽  
Primary Outcome Measure ◽  
Crisis Resolution ◽  
Randomised Controlled ◽  
The Impact

SummaryAims – The use of specialised services to avoid admission to hospital for people experiencing mental health crises is seen as an integral part of psychiatric services in some countries. The aim of this paper is to assess the impact on costs and costeffectiveness of a crisis resolution team (CRT). Methods – Patients who were experiencing mental health crises sufficient for admission to be considered were randomised to either care provided by a CRT or standard services. The primary outcome measure was inpatient days over a six-month follow-up period. Service use was measured, costs calculated and cost-effectiveness assessed. Results – Patients receiving care from the CRT had non-inpatient costs £768 higher than patients receiving standard care (90% CI, £153 to £1375). With the inclusion of inpatient costs the costs for the CRT group were £2438 lower for the CRT group (90% CI, £937 to £3922). If one less day spent as an inpatient was valued at £100, there would be a 99.5% likelihood of the CRT being costeffective. Conclusion – This CRT was shown to be cost-effective for modest values placed on reductions in inpatient stays.

scholarly journals A 10-year follow-up of tailored behavioural treatment and exercise-based physiotherapy for persistent musculoskeletal pain

2016 ◽  
Vol 31 (2) ◽  
pp. 186-196 ◽  
Author(s):  
Christina Emilson ◽  
Ingrid Demmelmaier ◽  
Stefan Bergman ◽  
Per Lindberg ◽  
Eva Denison ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Behavioural Medicine ◽  
Behavioural Treatment ◽  
Beneficial Effects ◽  
Maximum Pain ◽  
Secondary Outcomes ◽  
Randomised Controlled

Objective: To study the long-term outcomes of two interventions targeting patients with sub-acute and persistent pain in a primary care physiotherapy setting. Design: A 10-year follow-up of a two-armed randomised controlled trial, initially including 97 participants. Interventions: Tailored behavioural medicine treatment, applied in a physiotherapy context (experimental condition), and exercise-based physiotherapy (control condition). Main measures: Pain-related disability was the primary outcome. The maximum pain intensity, pain control, fear of movement, sickness-related absence (register data) and perceived benefit and confidence in coping with future pain problems were the secondary outcomes. Results: Forty-three (44%) participants responded to the follow-up survey, 20 in the tailored behavioural medicine treatment group and 23 in the exercise-based physiotherapy group. The groups did not differ in terms of the change in the scores for the primary outcome ( p=0.17) of pain-related disability between the experimental group (median: 2.5, Q1-Q3: -2.5-14.25), and the control group (median: 0, Q1-Q3: -5-6). Further, there were also no significant differences found for the secondary outcomes except for sickness-related absence, where the exercise-based physiotherapy group had more days of sickness-related absence three months before treatment ( p= 0.02), and at the 10-year follow-up ( p=0.03). Discussion: The beneficial effects favouring tailored behavioural medicine treatment that observed post-treatment and at the two-year follow-up were not maintained 10 years after treatment.

scholarly journals A randomised controlled trial of a theory-based interactive internet-based smoking cessation intervention (‘StopAdvisor’): Study protocol

2013 ◽  
Vol 8 (2) ◽  
pp. 63-70 ◽  
Author(s):  
Susan Michie ◽  
Jamie Brown ◽  
Adam W. A. Geraghty ◽  
Sascha Miller ◽  
Lucy Yardley ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Logistic Regression ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
The Social ◽  
Randomised Controlled

Background: Internet-based interventions can help smokers to quit compared with brief written materials or no intervention. However, they are not widely used, particularly by more disadvantaged smokers, and there is significant variation in their effectiveness. A new smoking cessation website (‘StopAdvisor’) has been systematically developed on the basis of PRIME theory, empirical evidence, web-design expertise and user-testing with socio-economically disadvantaged smokers. This paper reports the protocol of a randomised controlled trial to evaluate the efficacy of StopAdvisor and determine whether it translates across the social spectrum.Methods: The trial has two arms with participants randomised to the offer of the interactive ‘StopAdvisor’ website (intervention condition) or a non-interactive, static website (control condition). Participants are adults from the UK, who smoke every day and are willing to make a serious quit attempt within a month of enrolment. At least 4260 participants will be recruited with a minimum of 2130 in each of two socio-economic sub-groups. The intervention comprises a structured quit plan and a variety of theory- and evidence-based behaviour change techniques for smoking cessation. Tailored support is offered in the form of a series of tunnelled sessions and a variety of interactive menus for use up to a month before, and then for one month after quitting (http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The control is a static website that presents brief and standard advice on smoking cessation. Assessments are at baseline and 2-, 4- and 7-months post-enrolment. The primary outcome measure will be Russell Standard 6-months sustained abstinence, defined as self-reported continuous abstinence verified by saliva cotinine or anabasine at 7-month follow-up. Secondary outcome measures will include 7-day point-prevalence abstinence at 7-month follow-up, self-reported abstinence at 2- and 4-month follow-ups, satisfaction ratings of the website and quantitative indices of website interaction. All analyses will be by intention to treat and the main analysis will compare the two conditions on the primary outcome measure using a logistic regression model, adjusted for baseline characteristics. The efficacy of the intervention across the social spectrum will be assessed by a logistic regression focusing on the interaction between condition and socio-economic disadvantage.Trial registration: ISRCTN99820519.

scholarly journals Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

2019 ◽  
Vol 217 (3) ◽  
pp. 477-483 ◽  
Author(s):  
Stefan Priebe ◽  
Agnes Chevalier ◽  
Thomas Hamborg ◽  
Eoin Golden ◽  
Michael King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Social Isolation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Contacts ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

scholarly journals Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial

Thorax ◽  
2017 ◽  
Vol 73 (3) ◽  
pp. 213-221 ◽  
Author(s):  
Stephen E Wright ◽  
Kirsty Thomas ◽  
Gillian Watson ◽  
Catherine Baker ◽  
Andrew Bryant ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outcome Data ◽  
Physical Rehabilitation ◽  
Control Group ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Lost To Follow Up

BackgroundEarly physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known.MethodsWe conducted a randomised, parallel-group, allocation-concealed, assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months.ResultsWe recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67–273) min of physical rehabilitation on ICU compared with 86 (31–139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group.ConclusionsIn this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation.Trial registration numberISRCTN 20436833.

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