scholarly journals Optional Web-Based Videoconferencing Added to Office-Based Care for Women Receiving Psychotherapy During the Postpartum Period: Pilot Randomized Controlled Trial

10.2196/13172 ◽  
2019 ◽  
Vol 21 (6) ◽  
pp. e13172 ◽  
Author(s):  
Rebecca Yang ◽  
Simone N Vigod ◽  
Jennifer M Hensel
Keyword(s):  
Randomized Controlled Trial ◽  
Parental Stress ◽  
Postpartum Period ◽  
Controlled Trial ◽  
Depression Scale ◽  
Mental Health Program ◽  
Postpartum Women ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background Depression and anxiety during the postpartum period are common, with psychotherapy often being the preferred method of treatment. However, psychological, physical, and social barriers prevent women from receiving appropriate and timely psychotherapy. The option of receiving psychotherapy through videoconferencing (VC) during the postpartum period presents an opportunity for more accessible and flexible care. Objective The aim of this study was to assess the feasibility, acceptability, and preliminary effectiveness of optional VC added to usual office-based psychotherapy, with a psychotherapist during the postpartum period. Methods We conducted a pilot randomized controlled trial with 1:1 randomization to office-based care (treatment as usual; TAU) or office-based care with the option of VC (treatment as usual plus videoconferencing; TAU-VC) for psychotherapy during the postpartum period. We assessed the ability to recruit and retain postpartum women into the study from an urban perinatal mental health program offering postpartum psychotherapy, and we evaluated the uptake, acceptability, and satisfaction with VC as an addition to in-person psychotherapy. We also compared therapy attendance using therapist logs and symptoms between treatment groups. Symptoms were assessed at baseline and 3 months postrandomization with the Edinburgh Postnatal Depression Scale, Generalized Anxiety Disorder 7-item, and Parental Stress Scale. Furthermore, 3-month scores were compared between groups with intention-to-treat linear mixed-effects models controlling for baseline score. Results We enrolled 38 participants into the study, with 19 participants in each treatment group. Attendance data were available for all participants, with follow-up symptom measures available for 25 out of 38 participants (66%). Among the 19 TAU-VC participants, 14 participants (74%) utilized VC at least once. Most participants were highly satisfied with the VC option, and they reported average savings of Can $26 and 2.5 hours in travel and childcare expenses and time per appointment. There were no significant differences between the 2 groups for psychotherapy attendance or symptoms. Conclusions The option of VC appears to be an acceptable method of receiving psychotherapy for postpartum women, with benefits described in costs and time savings. On the basis of this small pilot sample, there were no significant differences in outcomes between office-based care with or without the option of VC. This study has demonstrated the feasibility of such a program in an urban center, which suggests that a larger study would be beneficial to provide evidence that is more conclusive.

scholarly journals Optional Web-Based Videoconferencing Added to Office-Based Care for Women Receiving Psychotherapy During the Postpartum Period: Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Rebecca Yang ◽  
Simone N Vigod ◽  
Jennifer M Hensel
Keyword(s):  
Randomized Controlled Trial ◽  
Parental Stress ◽  
Postpartum Period ◽  
Controlled Trial ◽  
Depression Scale ◽  
Mental Health Program ◽  
Postpartum Women ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND Depression and anxiety during the postpartum period are common, with psychotherapy often being the preferred method of treatment. However, psychological, physical, and social barriers prevent women from receiving appropriate and timely psychotherapy. The option of receiving psychotherapy through videoconferencing (VC) during the postpartum period presents an opportunity for more accessible and flexible care. OBJECTIVE The aim of this study was to assess the feasibility, acceptability, and preliminary effectiveness of optional VC added to usual office-based psychotherapy, with a psychotherapist during the postpartum period. METHODS We conducted a pilot randomized controlled trial with 1:1 randomization to office-based care (treatment as usual; TAU) or office-based care with the option of VC (treatment as usual plus videoconferencing; TAU-VC) for psychotherapy during the postpartum period. We assessed the ability to recruit and retain postpartum women into the study from an urban perinatal mental health program offering postpartum psychotherapy, and we evaluated the uptake, acceptability, and satisfaction with VC as an addition to in-person psychotherapy. We also compared therapy attendance using therapist logs and symptoms between treatment groups. Symptoms were assessed at baseline and 3 months postrandomization with the Edinburgh Postnatal Depression Scale, Generalized Anxiety Disorder 7-item, and Parental Stress Scale. Furthermore, 3-month scores were compared between groups with intention-to-treat linear mixed-effects models controlling for baseline score. RESULTS We enrolled 38 participants into the study, with 19 participants in each treatment group. Attendance data were available for all participants, with follow-up symptom measures available for 25 out of 38 participants (66%). Among the 19 TAU-VC participants, 14 participants (74%) utilized VC at least once. Most participants were highly satisfied with the VC option, and they reported average savings of Can $26 and 2.5 hours in travel and childcare expenses and time per appointment. There were no significant differences between the 2 groups for psychotherapy attendance or symptoms. CONCLUSIONS The option of VC appears to be an acceptable method of receiving psychotherapy for postpartum women, with benefits described in costs and time savings. On the basis of this small pilot sample, there were no significant differences in outcomes between office-based care with or without the option of VC. This study has demonstrated the feasibility of such a program in an urban center, which suggests that a larger study would be beneficial to provide evidence that is more conclusive.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Evaluating Seeking Safety for Women in Prison: A Randomized Controlled Trial

2017 ◽  
Vol 29 (3) ◽  
pp. 281-290 ◽  
Author(s):  
Stephen J. Tripodi ◽  
Annelise M. Mennicke ◽  
Susan A. McCarter ◽  
Katie Ropes
Keyword(s):  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Post Traumatic Stress ◽  
Treatment As Usual ◽  
Seeking Safety ◽  
Randomized Controlled

Objective: This study assessed the effectiveness of Seeking Safety on depression and post-traumatic stress disorder (PTSD) with incarcerated women. Method: A randomized controlled trial ( N = 40) was used to analyze Seeking Safety’s effectiveness compared to a treatment-as-usual control group. Analyses of covariance were used to assess differences at posttest ( n = 33) and 4-month follow-up ( n = 29) while repeated measures analysis of variance was used to assess the influence of the intervention on changes over time ( n = 29). The researchers also analyzed individual participants’ scores from pretest to 4-month follow-up ( n = 29). Results: Both groups decreased their scores on the Center for Epidemiology Studies–Depression Scale and the PTSD Checklist, although improvement was greater for treatment group participants except for depression at 4-month follow-up. Conclusion: Results support the continued use of Seeking Safety as a helpful corrections-based intervention for women, but more research with larger sample sizes is needed to consider it an effective intervention.

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. OBJECTIVE The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. METHODS This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. RESULTS The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. CONCLUSIONS The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21307

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial

10.2196/21307 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e21307
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. Objective The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. Methods This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. Results The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. Conclusions The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 International Registered Report Identifier (IRRID) DERR1-10.2196/21307

scholarly journals Cognitive–behavioural suicide prevention for male prisoners: a pilot randomized controlled trial

2015 ◽  
Vol 45 (16) ◽  
pp. 3441-3451 ◽  
Author(s):  
D. Pratt ◽  
N. Tarrier ◽  
G. Dunn ◽  
Y. Awenat ◽  
J. Shaw ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Psychiatric Symptomatology ◽  
Treatment As Usual ◽  
Psychological Determinants ◽  
Randomized Controlled ◽  
Cognitive Behavioural ◽  
Personality Dysfunction ◽  
Male Prisoners ◽  
Pilot Randomized Controlled Trial

Background.Prisoners have an exceptional risk of suicide. Cognitive–behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive–behavioural suicide prevention (CBSP) therapy for suicidal male prisoners.Method.A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209).Results.Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = −0.72, 95% confidence interval −1.71 to 0.09; baseline mean TAU: 1.39 (s.d. = 3.28) v. CBSP: 1.06 (s.d. = 2.10), 6 months mean TAU: 1.48 (s.d. = 3.23) v. CBSP: 0.58 (s.d. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group.Conclusions.The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

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