scholarly journals Efficacy of Six-weeks Therapist Guided Online-Therapy Versus Self-Help Internet-based Therapy on COVID-19 Invoked Anxiety and Depression Among Individuals in Oman During COVID-19 pandemic. An Open Label, Pragmatic Randomized Controlled Trial. (Preprint)

2020 ◽  
Author(s):  
Mohammed Al Alawi ◽  
Roopa K McCall ◽  
Alya Sultan ◽  
Naser Al Balushi ◽  
Tamadhir Al-Mahrouqi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety And Depression ◽  
Online Therapy ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Self Help ◽  
E Mail

BACKGROUND The coronavirus (COVID-19) pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions aiming at improving the increased levels of psychological distress arising from the COVID-19 pandemic. OBJECTIVE This study aimed at assessing the efficacy of therapist guided Online-Therapy versus self-help, e-mail delivered, therapy focusing on COVID-19-induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic. METHODS This was a 6-week pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety/depression among the public in Oman amid the COVID-19 pandemic. The participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman in Arabic or English. The Psychotherapists utilized Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) interventions. The participants in the control group received an automatic weekly newsletter via e-mail containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of CBT and ACT. The primary outcome was measured by comparing the change in the mean Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scores from baseline to the end of the study (after six sessions) between the two arms. The secondary outcome was comparing the proportions of participants with depression and anxiety in the two groups. RESULTS Data from 46 participants were analyzed (22 in intervention arm and 24 in control arm). There was no statistical difference in baseline characteristics between both arms. Analysis of covariance indicated a significant reduction in the GAD scores (F(1,43) = 7.307; P = 0.010) between the two arms after adjusting for baseline scores. The intervention arm GAD scores reduced more than those of the control arm (B = -3.27; P = 0.010). The intervention arm had a greater reduction in PHQ-9 mean scores (F(1,43) = 8.298; P = 0.006) when compared to the control arm (B = -4.311; P = 0.006). While the levels of anxiety and depression reduced in both study arms, the reduction was higher in the intervention group (P values of <0.049 and <0.022, respectively). CONCLUSIONS This study provides preliminary evidence to support the efficacy of Online-Therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist guided Online-Therapy was noted to be superior to self-help Internet-based therapy, however, both therapies could be considered as viable options. CLINICALTRIAL ClinicalTrials.gov NCT04378257

scholarly journals Efficacy of a Six-Week-Long Therapist-Guided Online Therapy Versus Self-help Internet-Based Therapy for COVID-19–Induced Anxiety and Depression: Open-label, Pragmatic, Randomized Controlled Trial

10.2196/26683 ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e26683
Author(s):  
Mohammed Al-Alawi ◽  
Roopa K McCall ◽  
Alya Sultan ◽  
Naser Al Balushi ◽  
Tamadhir Al-Mahrouqi ◽  
...  
Keyword(s):  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety And Depression ◽  
Control Group ◽  
Online Therapy ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Self Help ◽  
Acceptance And Commitment

Background The COVID-19 pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions that aim to improve the elevated levels of psychological distress due to the COVID-19 pandemic. Objective This study aimed to comparatively assess the efficacy of therapist-guided online therapy with that of self-help, internet-based therapy focusing on COVID-19–induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic. Methods This was a 6-week-long pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety or depression among the Omani public amid the COVID-19 pandemic. Participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman; these sessions were conducted in Arabic or English. The psychotherapists utilized cognitive behavioral therapy and acceptance and commitment therapy interventions. Participants in the control group received an automatic weekly newsletter via email containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of cognitive behavioral therapy and acceptance and commitment therapy. The primary outcome was measured by comparing the change in the mean scores of Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scale from the baseline to the end of the study (ie, after 6 sessions) between the two groups. The secondary outcome was to compare the proportions of participants with depression and anxiety between the two groups. Results Data from 46 participants were analyzed (intervention group n=22, control group n=24). There was no statistical difference in the baseline characteristics between both groups. Analysis of covariance indicated a significant reduction in the GAD-7 scores (F1,43=7.307; P=.01) between the two groups after adjusting for baseline scores. GAD-7 scores of participants in the intervention group were considerably more reduced than those of participants in the control group (β=−3.27; P=.01). Moreover, a greater reduction in mean PHQ-9 scores was observed among participants in the intervention group (F1,43=8.298; P=.006) than those in the control group (β=−4.311; P=.006). Although the levels of anxiety and depression reduced in both study groups, the reduction was higher in the intervention group (P=.049) than in the control group (P=.02). Conclusions This study provides preliminary evidence to support the efficacy of online therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist-guided online therapy was found to be superior to self-help, internet-based therapy; however, both therapies could be considered as viable options. Trial Registration ClinicalTrials.gov NCT04378257; https://clinicaltrials.gov/ct2/show/NCT04378257

Preliminary evaluation of a culturally adapted CBT-based online programme for depression and anxiety from a lower middle-income country

2021 ◽  
Vol 14 ◽  
Author(s):  
Madeeha Latif ◽  
Falahat Awan ◽  
Mirrat Gul ◽  
M. Omair Husain ◽  
M. Ishrat Husain ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety And Depression ◽  
Middle Income ◽  
Randomized Controlled ◽  
Self Help ◽  
Culturally Adapted

Abstract Online cognitive behaviour therapy (CBT), self-help and guided self-help (GSH) interventions have been found to be efficacious and cost-effective for treatment of anxiety and depression, but there are limited data from low- and middle-income countries on culturally adapted digital interventions for these common mental disorders. The aim of this study was to investigate the feasibility and acceptability of an online culturally adapted CBT-based guided self-help (CaCBT-GSH) for patients with anxiety and depression in Pakistan. This randomized controlled trial recruited 39 participants from primary care in Karachi, Pakistan and randomized them to two groups. The intervention group received seven modules of CaCBT-GSH plus treatment as usual (TAU) over 12 weeks. The control group was a waitlist control plus TAU. The primary outcomes were feasibility and acceptability. Clinical outcomes included results from the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule 2 (WHODAS 2). Assessments were carried out at baseline and at 12 weeks. All 39 individuals who met eligibility criteria for the study agreed to participate. Adherence to the intervention was excellent, with 85% (17/20) completing more than five modules. Statistically significant improvements were found in all clinical outcomes in the intervention group. This was the first trial of an online CaCBT-GSH intervention, which was found to be feasible and acceptable to Pakistani patients with anxiety and depression. CaCBT-GSH may help improve symptoms, depression, anxiety and overall functioning in this population. The results provide rationale for a larger, confirmatory randomized controlled trial of digital CaCBT-GSH. Key learning aims (1) Leveraging digital and virtual platforms to deliver psychosocial interventions may contribute to addressing the significant treatment gap in low-resource settings. (2) CBT-informed guided self-help is feasible and acceptable in the treatment of common mental disorders in Pakistan. (3) The results of this study merit a larger, appropriately powered confirmatory randomized controlled trial to determine clinical and cost effectiveness.

scholarly journals An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

scholarly journals An Internet-Based Self-Help Intervention for People with Psychological Distress Due to COVID-19: Study Protocol for A Randomized Controlled Trial.

2020 ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Related Quality ◽  
Health Related ◽  
Use Of Internet

Abstract Background: The Coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition.Methods: The design is a randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behaviour, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience and the satisfaction with and usability of the self-help program.Discussion: To the best of our knowledge, this is one of the first studies investigating an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress.Trial registration: ClinicalTrials.gov, NCT04380909, Retrospectively registered on 8 May 2020, https://clinicaltrials.gov/ct2/show/NCT04380909

scholarly journals Culturally adapted trauma-focused CBT-based guided self-help (CatCBT GSH) for female victims of domestic violence in Pakistan: feasibility randomized controlled trial

2020 ◽  
pp. 1-12
Author(s):  
Madeeha Latif ◽  
M. Ishrat Husain ◽  
Mirrat Gul ◽  
Saiqa Naz ◽  
Muhammad Irfan ◽  
...  
Keyword(s):  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Female Victims ◽  
Randomized Controlled ◽  
Self Help ◽  
Culturally Adapted ◽  
Cognitive Behaviour ◽  
Secondary Outcomes

Abstract Background: Cognitive behaviour therapy (CBT), self-help and guided self-help interventions have been found to be efficacious and cost effective for victims of trauma, but there are limited data from low- and middle-income countries on culturally adapted interventions for trauma. Aims: To investigate the feasibility and acceptability of culturally adapted trauma-focused CBT-based guided self-help (CatCBT GSH) for female victims of domestic violence in Pakistan. Method: This randomized controlled trial (RCT) recruited 50 participants from shelter homes in Karachi and randomized them to two equal groups. The intervention group received GSH in nine sessions over 12 weeks. The control group was a waitlist control. The primary outcomes were feasibility and acceptability. Secondary outcomes included Impact of Event Scale-Revised (IES-R), Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule 2 (WHO DAS 2). Assessments were carried out at baseline and at 12 weeks. Results: Out of 60 clients who met DSM-5 criteria for post-traumatic stress disorder (PTSD), 56 (93.3%) agreed to participate in the study. Retention to the intervention group was excellent, with 92% (23/25) attending more than six sessions. Statistically significant differences were noted post-intervention in secondary outcomes in favour of the intervention. Conclusions: A trial of CatCBT GSH was feasible and the intervention was acceptable to Pakistani women who had experienced domestic violence. Furthermore, it may be helpful in improving symptoms of PTSD, depression, anxiety and overall functioning in this population. The results provide a rationale for a larger, confirmatory RCT of CatCBT GSH.

Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial

2020 ◽  
pp. 1-9
Author(s):  
JianLi Wang ◽  
Heidi Eccles ◽  
Molly Nannarone ◽  
Norbert Schmitz ◽  
Scott Patten ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Mixed Methods ◽  
Functional Impairment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Risk Information ◽  
Control Group ◽  
Randomized Controlled ◽  
Depression Risk

Abstract Background Multivariable risk algorithms (MVRP) predicting the personal risk of depression will form an important component of personalized preventive interventions. However, it is unknown whether providing personalized depression risk will lead to unintended psychological harms. The objectives of this study were to evaluate the impact of providing personalized depression risk on non-specific psychological distress and functional impairment over 12 months. Methods A mixed-methods randomized controlled trial was conducted in 358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada. Participants were assessed at baseline, 6 and 12 months. Results Over 93% of participants were interested in knowing their depression risk. The intervention group had a greater reduction in K10 score over 12 months than the control group; complete-case analysis found a significant between-group difference in mean K10 change score (d = 1.17, 95% CI 0.12–2.23) at 12 months. Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group. A majority of the qualitative interviewees commented that personalized depression risk information does not have a negative impact on physical and mental health. Conclusions This study found no evidence that providing personalized depression risk information will lead to worsening psychological distress, functional impairment, and absenteeism. Provision of personalized depression risk information may have positive impacts on non-specific psychological distress and functioning. Trial registration ClinicalTrials.gov NCT02943876

Feasibility and effectiveness of activity-scheduling as a guided self-help intervention for the prevention of depression and anxiety in residents in homes for the elderly: a pragmatic randomized controlled trial

2011 ◽  
Vol 23 (6) ◽  
pp. 969-978 ◽  
Author(s):  
Els Dozeman ◽  
Digna J. F. van Schaik ◽  
Harm W. J. van Marwijk ◽  
Max L. Stek ◽  
Aartjan T. F. Beekman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Depression And Anxiety ◽  
Residential Homes ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Self Help

ABSTRACTBackground: Elderly people living in residential homes are at high risk for developing major depressive and anxiety disorders, and therefore deserve attention in terms of preventive interventions. We evaluated the feasibility and effectiveness of a guided self-help intervention for the prevention of depression and anxiety in these residents.Methods: We conducted a pragmatic randomized controlled trial in two parallel groups comparing the intervention with usual care in 14 residential homes in and surrounding the city of Amsterdam in the Netherlands. A total of 129 residents with a score of 8 or more on the Centre for Epidemiologic Studies Depression Scale (CES-D) screening instrument, who did not meet the full diagnostic criteria for disorders, and were not suffering from cognitive impairment were recruited between April 2007 and December 2008. Participants were randomized to a guided self-help intervention (n = 67) or to usual care (n = 62). The main outcome measures were improvement in the level of symptoms of depression and anxiety. The secondary outcome was improvement in participation in organized activities in the residential homes. The study is registered in de Dutch Cochrane Centre, under number ISRCTN27540731.Results: Only 21% of the participants (mean age 84.0 years (SD 6.7), 72.1% suffering from two or more chronic illnesses) completed the intervention. Although we found some large positive effect sizes on the CES-D, none of these effects was statistically significant.Conclusion: Although guided self-help may be promising in the prevention of depression and anxiety, it proved to be difficult to apply in this very old and vulnerable group of people living in residential homes.

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