Randomised controlled trial of cognitive behaviour therapy versus mindfulness for people with rheumatoid arthritis with and without a history of recurrent depression: study protocol and design.

INTRODUCTION: Psychosocial treatments have been shown to benefit people with rheumatoid arthritis (RA) on various outcomes. Two evidence-based interventions are cognitive behavioural therapy (CBT) and mindfulness-based stress reduction (MBSR). However, these interventions have been compared only once. Results showed that CBT outperformed MBSR on some outcomes, but MBSR was more effective for people with RA with a history of recurrent depression, with efficacy being moderated by history of depressive episodes. However, this was a post-hoc finding based on a small subsample. We aim to examine whether a history of recurrent depression will moderate the relative efficacy of these treatments when delivered online. METHODS AND ANALYSIS: This study is a randomised controlled trial comparing CBT and MBSR delivered online with a waitlist control condition. History of recurrent depressive episodes will be assessed at baseline. The primary outcome will be pain interference. Secondary outcomes will include pain intensity, RA symptoms, depressive symptoms and anxiety symptoms. Outcome measures will be administered at baseline, post-treatment and at 6 months follow-up. We aim to recruit 300 participants, and an intention-to-treat analysis will be used. Linear mixed models will be used, with baseline levels of treatment outcomes as the covariate, and group and depressive status as fixed factors. The results will demonstrate whether online CBT and MBSR effectively improve outcomes among people with RA. Importantly, this trial will determine whether one intervention is more efficacious, and whether prior history of depression moderates this effect. ETHICS AND DISSEMINATION: The trial has been approved by the Human Research Ethics Committee of the University of Sydney (2021/516). The findings will be subject to publication irrespective of the final results of the study, and based on the outcomes presented in this protocol. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000997853p).

A randomized controlled trial of a web-based mindfulness programme for people with MS with and without a history of recurrent depression.

BACKGROUND: Evidence shows small positive effects associated with psychological treatments for people with multiple sclerosis (PwMS). In a recent meta-analysis, the treatment with the largest effect size was a mindfulness-based intervention (MBI). OBJECTIVES: We aimed to determine whether an Internet-delivered MBI was beneficial for PwMS. Furthermore, we aimed to investigate history of recurrent depression as a moderator of treatment outcome. METHODS: Participants (N = 132) were assessed based on whether they had a history of recurrent depression, then stratified and randomized to MBI or waitlist. Outcomes were assessed at baseline, post-intervention, and 3 and 6 months. RESULTS: The MBI group reported significantly improved depressive symptoms (primary outcome) compared with the waitlist (p = 0.046, Cohen's d = 0.39). Those with a history of recurrent depression benefitted significantly more than those without (p = 0.034, d = 0.66). There were benefits for health-related quality of life (HRQoL) in the MBI, irrespective of depression history (p = 0.009, d = 0.5). Pain interference was less overall in the MBI group (p < 0.001, d = 0.2), but change over time did not differ from waitlist. There were no treatment effects for anxiety, pain severity or fatigue. CONCLUSION: The Internet-delivered MBI significantly improved depressive symptoms and HRQoL in PwMS. For depression, the benefits were greater for those with a history of recurrent depression. TRIAL REGISTRATION: ACTRN12618001260213, available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375598.

A Mindful Parenting Program for Parents Concerned About Child Internalizing Problems: a Randomized Controlled Feasibility Study.

Objectives: This study sought to establish four aspects of feasibility for a mindful parenting program: demand for the program from parents with concerns regarding their child's internalizing problems, acceptability of the program to those parents, preliminary efficacy, and the likelihood of successful expansion of the program to the intended population. Methods: The study was a pilot, randomized controlled trial comparing a mindful parenting program to waitlist. Participants were parents (N = 25) of children aged 3-18 years, with self-reported concerns regarding their child's internalizing problems, recruited from the community. Demand was assessed using recruitment and adherence rates. Acceptability was assessed using parent-reported usefulness. Preliminary efficacy was assessed using parent reports of child internalizing problems, mindful parenting, parenting stress, cognitive emotion regulation, parental experiential avoidance, and parent beliefs about child anxiety. Intervention group parents also provided weekly in-session data on coping in stressful parenting situations. The likelihood of successful expansion was assessed using qualitative feedback on whether and how the program had helped parents manage child internalizing problems, particularly anxiety. Results: Feasibility was established for the four aspects assessed. The program was well-attended and acceptable to parents. Moderate to large effects were found in favor of the intervention group for most parent and child outcomes. Weekly data showed improved coping in difficult parenting situations. Qualitative feedback suggested that parents believed that increased acceptance and empathy had helped them cope with child internalizing problems. Conclusions: Mindful parenting programs may assist parents of children with internalizing problems to manage parenting stress and emotionally regulate themselves, even in difficult parenting moments. They may also reduce child internalizing problems, through improved parental emotion regulation, and greater acceptance of and empathy for their child. Trial Registration: Australian Clinical Trials Registry, registration number ACTRN12620000690954.

Development of a Web-Based Mindfulness Program for People With Multiple Sclerosis: Qualitative Co-Design Study.

BACKGROUND: Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision. OBJECTIVE: This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible. METHODS: We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8). RESULTS: We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program. CONCLUSIONS: The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program.

The Interpersonal Mindfulness in Parenting Scale in Mothers of Children and Infants: Factor Structure and Associations With Child Internalizing Problems.

Objectives: Mindful parenting, measured by the Interpersonal Mindfulness in Parenting scale (IMP), is beneficial for parents and children. However, the IMP has not been validated in English-speaking parents. Further, little is known about whether mindful parenting is similar in parents of children vs. infants, or how it reduces child internalizing problems. We sought to validate the IMP in English-speaking mothers of children and infants, and to examine relationships between the facets of mindful parenting, child internalizing problems and parent variables related to internalizing. Methods: Using confirmatory factor analyses, we examined the fit of various models of mindful parenting in English-speaking community-recruited mothers of children aged 3-18 years (n = 396) and infants aged 0-2 years (n = 320). We used regression analyses to investigate relationships between the facets of mindful parenting, child internalizing problems, and parent variables including parental experiential avoidance, unhelpful beliefs about child anxiety and accommodation of child anxiety. Results: Mindful parenting can be measured in English-speaking mothers, using either a 5- or 6-factor, 29-item version of the IMP. These versions of the IMP operate similarly for mothers of children and infants. Child internalizing problems and related parent variables were best predicted by non-judgmental acceptance of parenting in mothers of children, and emotional self-awareness and non-reactivity in mothers of infants. Conclusions: The IMP is a valid measure of mindful parenting in English-speaking mothers of children and infants. Mindful parenting predicts child internalizing problems and related parent variables, suggesting that mindful parenting programs could benefit families of children with internalizing problems, potentially by reducing parental experiential avoidance, unhelpful beliefs about or accommodation of child anxiety.

The Effect of Mindfulness Interventions for Parents on Parenting Stress and Youth Psychological Outcomes: A Systematic Review and Meta-Analysis.

Background: The psychological well-being of parents and children is compromised in families characterized by greater parenting stress. As parental mindfulness is associated with lower parenting stress, a growing number of studies have investigated whether mindfulness interventions can improve outcomes for families. This systematic review and meta-analysis evaluates the effectiveness of mindfulness interventions for parents, in reducing parenting stress and improving youth psychological outcomes. Methods: A literature search for peer-reviewed articles and dissertations was conducted in accordance with PRISMA guidelines in the PsycInfo, Medline, PubMed, CINAHL, Web of Science, Cochrane Central Register of Controlled Trials, and ProQuest Dissertations & Theses databases. Studies were included if they reported on a mindfulness-based intervention delivered in person to parents with the primary aim of reducing parenting stress or improving youth psychological outcomes. Results: Twenty-five independent studies were included in the review. Eighteen studies used a single group design and six were randomized controlled trials. Within-groups, meta-analysis indicated a small, post-intervention reduction in parenting stress (g = 0.34), growing to a moderate reduction at 2 month follow-up (g = 0.53). Overall, there was a small improvement in youth outcomes (g = 0.27). Neither youth age or clinical status, nor time in mindfulness training, moderated parenting stress or overall youth outcome effects. Youth outcomes were not moderated by intervention group attendees. Change in parenting stress predicted change in youth externalizing and cognitive effects, but not internalizing effects. In controlled studies, parenting stress reduced more in mindfulness groups than control groups (g = 0.44). Overall, risk of bias was assessed as serious. Conclusions: Mindfulness interventions for parents may reduce parenting stress and improve youth psychological functioning. While improvements in youth externalizing and cognitive outcomes may be explained by reductions in parenting stress, it appears that other parenting factors may contribute to improvements in youth internalizing outcomes. Methodological weaknesses in the reviewed literature prevent firm conclusions from being drawn regarding effectiveness. Future research should address these methodological issues before mindfulness interventions for parents are recommended as an effective treatment option for parents or their children.

The evaluation of an online mindfulness program for people with multiple sclerosis: study protocol.

BACKGROUND: Multiple sclerosis (MS) is a neurological disease of the central nervous system and is associated with many psychosocial symptoms that are difficult to manage including low mood, anxiety, fatigue and pain, as well as low health-related quality of life. Internet-based psychosocial interventions that use mindfulness-based approaches are gathering much attention in recent literature, particularly in the treatment of chronic illnesses. However, no large randomized controlled trials have been done examining the efficacy of such interventions for people with MS (PwMS). METHODS/DESIGN: This study is a randomised controlled trial of an online mindfulness-based intervention (MBI) for PwMS. Participants will be randomised to receive either the MBI or offered the intervention after a waiting period. All participants will be assessed to determine whether they have a history of recurrent depressive disorder. The primary outcome will be severity of depression, according to the Centre of Epidemiology Depression Scale. Secondary outcomes will be anxiety severity, fatigue, pain and quality of life. Assessments will be conducted pre, post-treatment, at three and six-month follow-up. The online mindfulness-based program was developed in collaboration with end-users (n = 19 PwMS) who gave feedback about what would be feasible and acceptable, and the draft program was reviewed by both experts and patients. DISCUSSION: Multiple sclerosis is the most common acquired chronic neurological disease amongst young adults and is associated with a range of symptoms that can be difficult to cope with. In face-to-face interventions, a MBI demonstrated the largest effect in a recent meta-analysis of psychological treatments for PwMS, but MBIs for PwMS have not been delivered online. Hence, this trial will confirm whether MBIs can be efficacious when delivered online. A range of symptoms are assessed as outcomes so that the nature of benefits associated with the online MBI can be ascertained. TRIAL REGISTRATION: ACTRN12618001260213 . Date of Registration: 25/07/2018.