A randomized controlled trial of MoodSwings 2.0: An internet-based self-management program for bipolar disorder.

OBJECTIVES: MoodSwings 2.0 is an online self-guided intervention for bipolar disorder that includes educational modules, interactive tools, and discussion forums. The primary aim of the study was to determine if participation in MoodSwings 2.0 would result in decreased symptoms of depression and mania compared to the control condition. Secondary aims were to identify improvements in core depression symptoms, quality of life, medication adherence, functioning, and time to relapse. METHODS: This was a three-arm randomized controlled trial that compared two intervention arms against a peer support control group (forum). A total of 304 adults aged 21 to 65 years with a diagnosis of bipolar disorder were assigned to a forum-only control group (Group 1; n = 102), a forum plus modules treatment group (Group 2; n = 102), or a forum, modules, and tools treatment group (Group 3; n = 100), in addition to usual care. RESULTS: There was a significant intervention impact showing improvement on the primary outcome of depression for Group 2 compared to Group 1 (P = .05) with effect sizes (Cohen's d) ranging from 0.17 to 0.43. There was also a significant intervention impact showing improvement on the secondary outcome of core depression for Group 2 (P = .02) and Group 3 (P = .05), but worse physical functioning for Group 3 (P = .01), compared to Group 1. CONCLUSIONS: This study provides evidence of the efficacy of internet-based psychoeducation interventions for bipolar disorder in reducing depressive symptoms. Further investigation is needed to assess effectiveness in a public program.

Evaluating discussion board engagement in the MoodSwings online self-help program for bipolar disorder: protocol for an observational prospective cohort study.

BACKGROUND: Online, self-guided programs exist for a wide range of mental health conditions, including bipolar disorder, and discussion boards are often part of these interventions. The impact engagement with these discussion boards has on the psychosocial well-being of users is largely unknown. More specifically we need to clarify the influence of the type and level of engagement on outcomes. The primary aim of this exploratory study is to determine if there is a relationship between different types (active, passive or none) and levels (high, mid and low) of discussion board engagement and improvement in outcome measures from baseline to follow up, with a focus on self-reported social support, stigma, quality of life and levels of depression and mania. The secondary aim of this study is to identify any differences in demographic variables among discussion users. METHODS/DESIGN: The present study is a sub-study of the MoodSwings 2.0 3-arm randomised controlled trial (discussion board only (arm 1), discussion board plus psychoeducation (arm 2), discussion board, psychoeducation plus cognitive behavioural therapy-based tools (arm 3)). Discussion engagement will be measured via online participant activity monitoring. Assessments include online self-report as well as blinded phone interviews at baseline, 3, 6, 9 and 12 months follow up. DISCUSSION: The results of this study will help to inform future programs about whether or not discussion boards are a beneficial inclusion in online self-help interventions. It will also help to determine if motivating users to actively engage in online discussion is necessary, and if so, what level of engagement is optimal to produce the most benefit. Future programs may benefit through being able to identify those most likely to poorly engage, based on demographic variables, so motivational strategies can be targeted accordingly. TRIAL REGISTRATION: ClinicalTrials.gov NCT02118623 registered April 15 2014 and NCT02106078 registered May 16 2013.

Development of an online intervention for bipolar disorder. www.moodswings.net.au.

We describe the development process and completed structure, of a self-help online intervention for bipolar disorder, known as MoodSwings ( www.moodswings.net.au) . The MoodSwings program was adapted as an Internet intervention from an efficacious and validated face-to-face, group-based psychosocial intervention. The adaptation was created by a psychologist, who had previously been involved with the validation of the face-to-face program, in collaboration with website designers. The project was conducted under the supervision of a team of clinician researchers. The website is available at no cost to registered participants. Self-help modules are accessed sequentially. Other features include a mood diary and a moderated discussion board. There has been an average of 1,475,135 hits on the site annually (2008 and 2009), with some 7400 unique visitors each year. A randomised controlled trial based on this program has been completed. Many people with bipolar disorder are accepting of the Internet as a source of treatment and, once engaged, show acceptable retention rates. The Internet appears to be a viable means of delivering psychosocial self-help strategies.

Cost-Utility and Cost-effectiveness of MoodSwings 2.0, an Internet-Based Self-management Program for Bipolar Disorder: Economic Evaluation Alongside a Randomized Controlled Trial.

BACKGROUND: Internet-delivered psychosocial interventions can overcome barriers to face-to-face psychosocial care, but limited evidence supports their cost-effectiveness for people with bipolar disorders (BDs). OBJECTIVE: This study aimed to conduct within-trial cost-effectiveness and cost-utility analyses of an internet-based intervention for people with BD, MoodSwings 2.0, from an Australian health sector perspective. METHODS: MoodSwings 2.0 included an economic evaluation alongside an international, parallel, and individually stratified randomized controlled trial comparing an internet-based discussion forum (control; group 1), a discussion forum plus internet-based psychoeducation (group 2), and a discussion forum plus psychoeducation and cognitive behavioral tools (group 3). The trial enrolled adults (aged 21 to 65 years) with a diagnosis of BD assessed by telephone using a structured clinical interview. Health sector costs included intervention delivery and additional health care resources used by participants over the 12-month trial follow-up. Outcomes included depression symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS; the trial primary outcome) and quality-adjusted life years (QALYs) calculated using the short-form 6-dimension instrument derived from the 12-item version of the short-form health survey. Average incremental cost-effectiveness (cost per MADRS score) and cost-utility (cost per QALY) ratios were calculated using estimated mean differences between intervention and control groups from linear mixed effects models in the base case. RESULTS: In total, 304 participants were randomized. Average health sector cost was lowest for group 2 (Aus $9431, SD Aus $8540; Aus $1=US $0.7058) compared with the control group (Aus $15,175, SD Aus $17,206) and group 3 (Aus $15,518, SD Aus $30,523), but none was statistically significantly different. The average QALYs were not significantly different among the groups (group 1: 0.627, SD 0.062; group 2: 0.618, SD 0.094; and group 3: 0.622, SD 0.087). The MADRS scores were previously shown to differ significantly between group 2 and the control group at all follow-up time points (P<.05). Group 2 was dominant (lower costs and greater effects) compared with the control group for average incremental cost per point decrease in MADRS score over 12 months (95% CI dominated to Aus $331). Average cost per point change in MADRS score for group 3 versus the control group was dominant (95% CI dominant to Aus $22,585). Group 2 was dominant (95% CI Aus $43,000 to dominant) over the control group based on lower average health sector cost and average QALY benefit of 0.012 (95% CI -0.009 to 0.033). Group 3, compared with the control group, had an average incremental cost-effectiveness ratio of dominant (95% CI dominated to Aus $19,978). CONCLUSIONS: Web-based psychoeducation through MoodSwings 2.0 has the potential to be a cost-effective intervention for people with BD. Additional research is needed to understand the lack of effectiveness for the addition of cognitive behavioral tools with the group 3 intervention.

Group-based psychosocial intervention for bipolar disorder: randomised controlled trial.

BACKGROUND: Psychosocial interventions have the potential to enhance relapse prevention in bipolar disorder. AIMS: To evaluate a manualised group-based intervention for people with bipolar disorder in a naturalistic setting. METHOD: Eighty-four participants were randomised to receive the group-based intervention (a 12-week programme plus three booster sessions) or treatment as usual, and followed up with monthly telephone interviews (for 9 months post-intervention) and face-to-face interviews (at baseline, 3 months and 12 months). RESULTS: Participants who received the group-based intervention were significantly less likely to have a relapse of any type and spent less time unwell. There was a reduced rate of relapse in the treatment group for pooled relapses of any type (hazard ratio 0.43, 95% CI 0.20-0.95; t(343) = -2.09, P = 0.04). CONCLUSIONS: This study suggests that the group-based intervention reduces relapse risk in bipolar disorder.

Supporting Regional Aged Care Nursing Staff to Manage Residents' Behavioural and Psychological Symptoms of Dementia, in Real Time, Using the Nurses' Behavioural Assistant (NBA): A Pilot Site 'End-User Attitudes' Trial.

BACKGROUND: This regional pilot site 'end-user attitudes' study explored nurses' experiences and impressions of using the Nurses' Behavioural Assistant (NBA) (a knowledge-based, interactive ehealth system) to assist them to better respond to behavioural and psychological symptoms of dementia (BPSD) and will be reported here. METHODS: Focus groups were conducted, followed by a four-week pilot site 'end-user attitudes' trial of the NBA at a regional aged care residential facility (ACRF). Brief interviews were conducted with consenting nursing staff. RESULTS: Focus group feedback (N = 10) required only minor cosmetic changes to the NBA prototype. Post pilot site end-user interview data (N = 10) indicated that the regional ACRF nurses were positive and enthusiastic about the NBA, however several issues were also identified. CONCLUSIONS: Overall the results supported the utility of the NBA to promote a person centred care approach to managing BPSD. Slight modifications may be required to maximise its uptake across all ACRF nursing staff.

Online ethics: where will the interface of mental health and the internet lead us?

While e-health initiatives are poised to revolutionize delivery and access to mental health care, conducting clinical research online involves specific contextual and ethical considerations. Face-to-face psychosocial interventions can at times entail risk and have adverse psychoactive effects, something true for online mental health programs too. Risks associated with and specific to internet psychosocial interventions include potential breaches of confidentiality related to online communications (such as unencrypted email), data privacy and security, risks of self-selection and self-diagnosis as well as the shortcomings of receiving psychoeducation and treatment at distance from an impersonal website. Such ethical issues need to be recognized and proactively managed in website and study design as well as treatment implementation. In order for online interventions to succeed, risks and expectations of all involved need to be carefully considered with a focus on ethical integrity.

A randomized head to head trial of MoodSwings.net.au: an Internet based self-help program for bipolar disorder.

BACKGROUND: Adjunctive psychosocial interventions are efficacious in bipolar disorder, but their incorporation into routine management plans are often confounded by cost and access constraints. We report here a comparative evaluation of two online programs hosted on a single website (www.moodswings.net.au). A basic version, called MoodSwings (MS), contains psychoeducation material and asynchronous discussion boards; and a more interactive program, MoodSwings Plus (MS-Plus), combined the basic psychoeducation material and discussion boards with elements of Cognitive Behavioral Therapy. These programs were evaluated in a head-to-head study design. METHOD: Participants with Bipolar I or II disorder (n=156) were randomized to receive either MoodSwings or MoodSwings-Plus. Outcomes included mood symptoms, the occurrence of relapse, functionality, Locus of Control, social support, quality of life and medication adherence. RESULTS: Participants in both groups showed baseline to endpoint reductions in mood symptoms and improvements in functionality, quality of life and medication adherence. The MoodSwings-Plus group showed a greater number of within-group changes on symptoms and functioning in depression and mania, quality of life and social support, across both poles of the illness. MoodSwings-Plus was superior to MoodSwings in improvement on symptoms of mania scores at 12 months (p=0.02) but not on the incidence of recurrence. LIMITATIONS: The study did not have an attention control group and therefore could not demonstrate efficacy of the two active arms. There was notable (81%) attrition by 12 months from baseline. CONCLUSION: This study suggests that both CBT and psychoeducation delivered online may have utility in the management of bipolar disorder. They are feasible, readily accepted, and associated with improvement.

A brief review of exercise, bipolar disorder, and mechanistic pathways.

Despite evidence that exercise has been found to be effective in the treatment of depression, it is unclear whether these data can be extrapolated to bipolar disorder. Available evidence for bipolar disorder is scant, with no existing randomized controlled trials having tested the impact of exercise on depressive, manic or hypomanic symptomatology. Although exercise is often recommended in bipolar disorder, this is based on extrapolation from the unipolar literature, theory and clinical expertise and not empirical evidence. In addition, there are currently no available empirical data on program variables, with practical implications on frequency, intensity and type of exercise derived from unipolar depression studies. The aim of the current paper is to explore the relationship between exercise and bipolar disorder and potential mechanistic pathways. Given the high rate of medical co-morbidities experienced by people with bipolar disorder, it is possible that exercise is a potentially useful and important intervention with regard to general health benefits; however, further research is required to elucidate the impact of exercise on mood symptomology.

The role of psychotherapy in bipolar disorder.

Adjunctive psychosocial interventions for bipolar disorder target many of the issues that are not addressed by medication alone, including non-adherence, efficacy-effectiveness gap and functionality. Psychosocial interventions have been found to reduce relapse, particularly for the depressive pole, and improve functionality. Approaches such as psychoeducation, cognitive behaviour therapy, interpersonal and social rhythm therapy, and family therapy have shown benefits as adjunctive treatments. Each of the various psychosocial interventions has a unique emphasis, but they share common elements. These include: providing information and education; developing a personal understanding of the illness, such as triggers and early warning signs; having prepared strategies in place for early intervention, should symptoms of illness develop; and promoting a collaborative approach. Evidence to date supports the use of adjunctive psychosocial interventions in the management of bipolar disorder.

Pilot of group intervention for bipolar disorder.

Objective. This pilot study aimed to determine whether a group based psychosocial intervention reduced rates of relapse, improved function and quality of life in people with bipolar disorder. Method. Patients with a diagnosis of bipolar disorder, types I and II were recruited in the Geelong Region of Victoria. Patients were assessed at baseline for psychiatric status, mood episode, function, and medication adherence. They were randomly assigned to either the intervention arm, a 12-week, structured group-based therapy as an adjunct to treatment as usual or the control arm, which consisted of treatment as usual, plus weekly phone calls. Participants were then followed up for a period of 3 months and assessed by a researcher blinded to treatment and control interventions. Results. Functioning as measured by the Global Assessment of Functioning (GAF) was significantly improved in the intervention group (P=0.008). The social relationships subscale on the (WHOQoL-BREF) showed significant results (P<0.05 level). There was also a positive trend in reduction of relapses in the intervention group. Conclusion. The use of a group intervention for bipolar disorder as an adjunct to usual treatment has potential benefits, both in reduction of relapse and improvement in functionality, and may be a cost effective way of delivering psychosocial treatments.