Web-Based Self-Compassion Training to Improve the Well-Being of Youth With Chronic Medical Conditions: Randomized Controlled Trial.

BACKGROUND: Up to one-third of young people live with chronic physical conditions (eg, diabetes, asthma, and autoimmune disease) that frequently involve recurrent pain, fatigue, activity limitations, stigma, and isolation. These issues may be exacerbated as young people transition through adolescence. Accordingly, young people with chronic illness are at a high risk of psychological distress. Accessible, evidence-based interventions for young people with chronic illnesses are urgently needed to improve well-being, support adaptation, and enhance daily functioning. Self-compassion, which is an adaptive means of relating to oneself during times of difficulty, is a promising intervention target for this population. OBJECTIVE: This study aims to test the efficacy of a 4-week, self-guided, web-based self-compassion training program for improving well-being among young Australians (aged 16-25 years) living with a chronic medical condition. The primary outcomes were self-compassion, emotion regulation difficulties, and coping; the secondary outcomes were well-being, distress, and quality of life. We also sought to test whether changes in primary outcomes mediated changes in secondary outcomes and gather feedback about the strengths and limitations of the program. METHODS: We conducted a single-blind, parallel-group, randomized controlled trial comparing a 4-week, fully automated, web-based self-compassion training program with a waitlist control. Participants were recruited via the internet, and outcomes were self-assessed at 4 (T1) and 12 weeks (T2) after the baseline time point via a web-based survey. A mixed methods approach was used to evaluate the program feedback. RESULTS: Overall, 151 patients (age: mean 21.15, SD 2.77 years; female patients: n=132, 87.4%) were randomized to the intervention (n=76, 50.3%) and control (n=75, 49.7%) groups. The loss-to-follow-up rate was 47.4%, and program use statistics indicated that only 29% (22/76) of young people in the experimental group completed 100% of the program. The main reported barrier to completion was a lack of time. As anticipated, treatment effects were observed for self-compassion (P=.01; partial η2=0.05; small effect); well-being (P≤.001; partial η2=0.07; medium effect); and distress (P=.003; partial η2=0.054; small-medium effect) at the posttest time point and maintained at follow-up. Contrary to our hypotheses, no intervention effects were observed for emotion regulation difficulties or maladaptive coping strategies. Improvements in adaptive coping were observed at the posttest time point but were not maintained at follow-up. Self-compassion, but not emotion regulation difficulties or coping, mediated the improvements in well-being. CONCLUSIONS: Minimal-contact, web-based self-compassion training can confer mental health benefits on young people with chronic conditions. This group experiences substantial challenges to participation in mental health supports, and program engagement and retention in this trial were suboptimal. Future work should focus on refining the program content, engagement, and delivery to optimize engagement and treatment outcomes for the target group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry 12619000572167; https://tinyurl.com/5n6hevt. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-020-8226-7.

Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial.

BACKGROUND: Promoting psychological well-being and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother's health and well-being, psychological distress in pregnancy increases the risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability in the postpartum period. Mindfulness and compassion-based interventions show potential for prevention and early intervention for perinatal distress. As there is an established need for accessible, scalable, flexible, and low-cost interventions, there is increased interest in the delivery of these programs on the web. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation). OBJECTIVE: The primary objective of this study is to assess the feasibility of an RCT protocol comparing the 3 conditions delivered on the web as a series of instructional materials and brief daily practices over a course of 8 weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate SD values for the outcome measures to inform the design of an adequately powered trial to determine the comparative efficacy of the different conditions. METHODS: Pregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age. We will assess the acceptability and feasibility of recruitment and retention strategies and the participants' engagement and adherence to the interventions. We will also assess the experiences of women in each of the 3 intervention conditions by measuring weekly changes in their well-being and engagement with the program and by conducting a qualitative analysis of postprogram interviews. RESULTS: This project was funded in September 2019 and received ethics approval on July 8, 2020. Enrollment to the study will commence in September 2020. Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria. CONCLUSIONS: If the study is shown to be feasible, results will be used to inform future full-scale RCTs. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote well-being and reduce psychological distress among pregnant women. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number 12620000672954p; http://anzctr.org.au/ACTRN12620000672954p.aspx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/19803.

Online Obsessive-Compulsive Disorder Treatment: Preliminary Results of the "OCD? Not Me!" Self-Guided Internet-Based Cognitive Behavioral Therapy Program for Young People.

BACKGROUND: The development and evaluation of Internet-delivered cognitive behavioral therapy (iCBT) interventions provides a potential solution for current limitations in the acceptability, availability, and accessibility of mental health care for young people with obsessive-compulsive disorder (OCD). Preliminary results support the effectiveness of therapist-assisted iCBT for young people with OCD; however, no previous studies have examined the effectiveness of completely self-guided iCBT for OCD in young people. OBJECTIVE: We aimed to conduct a preliminary evaluation of the effectiveness of the OCD? Not Me! program for reducing OCD-related psychopathology in young people (12-18 years). This program is an eight-stage, completely self-guided iCBT treatment for OCD, which is based on exposure and response prevention. METHODS: These data were early and preliminary results of a longer study in which an open trial design is being used to evaluate the effectiveness of the OCD? Not Me! PROGRAM: Participants were required to have at least subclinical levels of OCD to be offered the online program. Participants with moderate-high suicide/self-harm risk or symptoms of eating disorder or psychosis were not offered the program. OCD symptoms and severity were measured at pre- and posttest, and at the beginning of each stage of the program. Data was analyzed using generalized linear mixed models. RESULTS: A total of 334 people were screened for inclusion in the study, with 132 participants aged 12 to 18 years providing data for the final analysis. Participants showed significant reductions in OCD symptoms (P<.001) and severity (P<.001) between pre- and posttest. CONCLUSIONS: These preliminary results suggest that fully automated iCBT holds promise as a way of increasing access to treatment for young people with OCD; however, further research needs to be conducted to replicate the results and to determine the feasibility of the program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000152729; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363654 (Archived by WebCite at http://www.webcitation.org/ 6iD7EDFqH).