scholarly journals Brief videoconferencing psychological intervention for reducing COVID-19 related distress: study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dharani Keyan ◽  
Katie Dawson ◽  
Suzanna Azevado ◽  
Srishti Yadav ◽  
Jenny Tran ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Study Protocol ◽  
Sleep Problems ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Trial Registration ◽  
World Health ◽  
Randomized Controlled

Abstract Background Globally COVID-19 has had a profound impact on the psychological wellbeing of millions of people, and there is an urgent imperative to address elevated levels of distress during the COVID-19 pandemic. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a low intensity psychological intervention for adults experiencing psychological distress. This paper outlines the study protocol for a trial that tests the effectiveness of an adapted version of PM+ to reduce distress associated with COVID-19. Methods A single-blind, parallel, randomized controlled trial will be carried out for distressed people across Australia. via video conferencing on a small group basis. Following informed consent, adults that screen positive for levels of psychological distress (General Health Questionnaire-12 (GHQ-12 score ≥ 3) and have access to videoconferencing platform will be randomised to an adapted version of gPM+ (n = 120) or enhanced treatment as usual (ETAU) (n = 120). The primary outcome will be reduction in psychological distress including anxiety and depression at 2-months post treatment. Secondary outcomes include worry, sleep problems, anhedonia, social support, and stress in relation to COVID-19. Discussion The trial aims assess whether an adapted version of videoconferencing PM+ that is specifically designed to target COVI-19 related distress will result in reduced distress relative to enhanced usual care. Trial registration This trial was prospectively registered on the ANZCTR on 14/4/20 (ACTRN12620000468921).

scholarly journals Protocol for a Phase Two, Parallel Three-Armed Non-inferiority Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT-Adjust) Comparing Face-to-Face and Video Conferencing Delivery to Individuals With Traumatic Brain Injury Experiencing Psychological Distress

2021 ◽  
Vol 12 ◽  
Author(s):  
Diane L. Whiting ◽  
Grahame K. Simpson ◽  
Frank P. Deane ◽  
Sarah L. Chuah ◽  
Michelle Maitz ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Brain Injury ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Evidence Based ◽  
Face To Face ◽  
Randomized Controlled ◽  
Severe Tbi

Background: People with traumatic brain injury (TBI) face a range of mental health challenges during the adjustment process post-injury, but access to treatment can be difficult, particularly for those who live in regional and remote regions. eHealth provides the potential to improve access to evidence-based psychological therapy for people with a severe TBI. The aim of the current study is to assess the efficacy of a psychological intervention delivered via video consulting to reduce psychological distress in people with TBI.Methods: This paper outlines the protocol for a multi-center, three-arm, parallel, non-inferiority randomized controlled trial (RCT) of an evidence-based manualized psychological intervention, ACT-Adjust. ACT-Adjust provides nine sessions for adults with a moderate to severe TBI experiencing clinical levels of psychological distress. Fifty-six participants referred from Brain Injury Rehabilitation Units across New South Wales (NSW) and the NSW icare scheme will be randomly allocated to three conditions; (1) video consulting (VC), (2) face-to-face (FtF) and, (3) a waitlist control (WL).Discussion: This is the first RCT to evaluate the efficacy of a psychological therapy (ACT-Adjust) delivered via video consulting for individuals with a moderate to severe TBI.Trial Registration:www.anzctr.org.au, Australian New Zealand Clinical Trials Registry ANZCTRN2619001602112.

scholarly journals Effectiveness of self-help plus (SH+) in reducing anxiety and post-traumatic symptomatology among care home workers during the COVID-19 pandemic: a randomized controlled trial

2021 ◽  
Vol 8 (11) ◽  
Author(s):  
Marianna Riello ◽  
Marianna Purgato ◽  
Chiara Bove ◽  
Federico Tedeschi ◽  
David MacTaggart ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
World Health ◽  
Treatment As Usual ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Self Help ◽  
Post Traumatic ◽  
Specific Factors

This article describes a randomized controlled trial to evaluate the effectiveness of a supervised online delivery of self-help plus (SH+), during the second wave of COVID-19 contagions in Northern Italy. The SH+ is a psychological intervention developed by the World Health Organization to increase a person's ability to deal with stress. In this trial, it was tested primarily as a tool to reduce anxiety and post-traumatic symptomatology in workers of residential nursing and care homes. In order to partial out non-specific effects of the intervention, the SH+ was compared to an equally supervised and structured alternative activity. Secondarily, in view of future emergencies, the potential of SH+ as a tool to reduce perceived stress, increase subjective well-being and foster individual resilience was explored. At post-intervention, the preregistered analysis revealed no difference in self-reported anxiety and/or post-traumatic symptomatology between the group receiving the SH+ and the group engaged in an alternative activity. Some specific and positive effects of the SH+ intervention were only found on self-reported intervention effectiveness and engagement in exploratory analyses. These findings raise the question whether the previously documented effectiveness of the SH+ on self-reported symptomatology and on the prevention of psychiatric conditions could be attributed mostly to non-specific rather than specific factors connected with participant enrolment in a psychological intervention. Indeed, the effects of the SH+ had been previously compared only to the effects of not being engaged in any alternative activity (often described in the literature as ‘treatment as usual’—or ‘enhanced treatment as usual’, when some relevant information is given to the control group as a one-off). Given the negative findings of this study, before the SH+ is implemented in clinical practice, further studies should be conducted to examine its short- and long-term beneficial effects, by means of randomized studies that employ alternative but similarly structured interventions as control conditions, aiming to minimize the confounding effect of non-specific factors.

scholarly journals Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Lianne M. Tomfohr-Madsen ◽  
Tavis S. Campbell ◽  
Gerald F. Giesbrecht ◽  
Nicole L. Letourneau ◽  
Linda E. Carlson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Cognitive Therapy ◽  
Study Protocol ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
In Pregnancy

Internet-Based Acceptance and Commitment Therapy for Psychological Distress Experienced by People With Hearing Problems: Study Protocol for a Randomized Controlled Trial

2015 ◽  
Vol 24 (3) ◽  
pp. 307-310 ◽  
Author(s):  
Peter Molander ◽  
Hugo Hesser ◽  
Sandra Weineland ◽  
Kajsa Bergwall ◽  
Sonia Buck ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Acceptance And Commitment Therapy ◽  
Study Protocol ◽  
Controlled Trial ◽  
The Internet ◽  
Randomized Controlled ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Hearing Difficulties

Purpose Psychological distress and psychiatric symptoms are prevalent among people with hearing loss or other audiological conditions, but psychological interventions for these groups are rare. This article describes the study protocol for a randomized controlled trial for evaluating the effect of a psychological treatment delivered over the Internet for individuals with hearing problems and concurrent psychological distress. Method Participants who are significantly distressed will be randomized to either an 8-week Internet-delivered acceptance-based cognitive behavioral therapy (i.e., acceptance and commitment therapy [ACT]), or wait-list control. We aim to include measures of distress associated with hearing difficulties, anxiety, and depression. In addition, we aim to measure acceptance associated with hearing difficulties as well as quality of life. Conclusion The results of the trial may further our understanding of how to best treat people who present problems with both psychological distress and hearing in using the Internet.

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