Dataset Information

Twelve-Month Follow-Up of a Randomized Controlled Trial of Internet-Based Guided Self-Help for Parents of Children on Cancer Treatment.

ABSTRACT:

Background

A substantial proportion of parents of children on cancer treatment report psychological distress such as symptoms of post-traumatic stress (PTSS), depression, and anxiety. During their child's treatment many parents also experience an economic burden.

Objective

The aim of this study was to evaluate the long-term efficacy of Internet-based guided self-help for parents of children on cancer treatment.

Methods

This study was a parallel randomized controlled trial comparing a 10-week Internet-based guided self-help program, including weekly support from a therapist via encrypted email, with a wait-list control condition. The intervention was based on cognitive behavior therapy (CBT) and focused on psychoeducation and skills to cope with difficult thoughts and feelings. Primary outcome was self-reported PTSS. Secondary outcomes were self-reported symptoms of depression, anxiety, health care consumption, and sick leave during the past month. Outcomes were assessed pre- and postintervention and at 12-month follow-up. Parents of children on cancer treatment were invited by health care personnel at pediatric oncology centers, and parents meeting the modified symptom criteria on the PCL-C were included in the study. Self-report assessments were provided on the Web.

Results

A total of 58 parents of children on cancer treatment (median months since diagnosis=3) were included in the study (intervention n=31 and control n=27). A total of 18 participants completed the intervention, and 16 participants in each group participated in the 12-month follow-up. Intention-to-treat analyses revealed significant effects in favor of the intervention on the primary outcome PTSS, with large between-group effect sizes at postassessment (d=0.89; 95% CI 0.35-1.43) and at 12-month follow-up (d=0.78; 95% CI 0.25-1.32). Significant effects in favor of the intervention on the secondary outcomes depression and anxiety were also observed. However, there was no evidence for intervention efficacy on health care consumption or sick leave.

Conclusions

Using the Internet to provide psychological interventions shows promise as an effective mode of delivery for parents reporting an increased level of PTSS and who consider Internet-based interventions as a viable option. Future research should corroborate these findings and also develop and evaluate interventions and policies that may help ameliorate the economic burden that parents may face during their child's treatment for cancer.

SUBMITTER: Cernvall M

PROVIDER: S-EPMC5553001 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Publications

Twelve-Month Follow-Up of a Randomized Controlled Trial of Internet-Based Guided Self-Help for Parents of Children on Cancer Treatment.

Cernvall Martin M Carlbring Per P Wikman Anna A Ljungman Lisa L Ljungman Gustaf G von Essen Louise L

Journal of medical Internet research 20170727 7

<h4>Background</h4>A substantial proportion of parents of children on cancer treatment report psychological distress such as symptoms of post-traumatic stress (PTSS), depression, and anxiety. During their child's treatment many parents also experience an economic burden.<h4>Objective</h4>The aim of this study was to evaluate the long-term efficacy of Internet-based guided self-help for parents of children on cancer treatment.<h4>Methods</h4>This study was a parallel randomized controlled trial c ...[more]

PMID: 28751300

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Project description:BackgroundA recent paper reported the outcomes of a study examining a new self-guided internet-delivered treatment, the Wellbeing Course, for symptoms of anxiety or depression. This study found the intervention resulted in significant symptom reductions. It also found that automated emails increased treatment completion and clinical improvements in a subsample with elevated anxiety and depression.AimsTo examine the clinical outcomes and the effect of automated emails at 12 months post-treatment.MethodParticipants, who were randomly allocated to a Treatment Plus Automated Emails Group (TEG; n = 100), a standard Treatment Group (TG; n = 106) or delayed-treatment Waitlist Control Group (Control; n = 51), were followed up at 12 months post-treatment. Eighty-one percent, 78% and 87% of participants in the TEG, TG and treated Waitlist Control Group provided symptom data at 12-month follow-up, respectively. The primary outcome measures were the Patient Health Questionnaire-9 Item Scale (PHQ-9) and the Generalized Anxiety Disorder-7 Item Scale (GAD-7).ResultsSignificant improvements in symptoms of anxiety and depression were observed over time in both the TEG and TG (Fs >69, ps <.001) these were sustained from post-treatment to 12-month follow-up (ps >.05), and were associated with large effect sizes. No statistically significant differences in symptoms were found between the TEG and TG at post-treatment, 3-month or 12-month follow-up. Previously reported symptom differences between TEG and TG participants with comorbid symptoms were no longer present at 12-month follow-up (ps >.70).ConclusionsThe overall benefits of the Wellbeing Course were sustained at 12-month follow-up. Although automated emails facilitated Course completion and reductions in symptoms for participants with comorbid anxiety and depression from pre-post treatment, these differences were no longer observed at 12-month follow-up. The results indicate that automated emails promote more rapid treatment response for people with elevated and comorbid symptoms, but may not improve longer term outcomes.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12610001058066.

Project description:IntroductionA subgroup of parents of children previously treated for cancer report long-term psychological distress after end of treatment. However, needs for psychological support are commonly unmet and there is a lack of evidence-based treatments tailored to the specific needs of this population. An internet-administered, guided, cognitive-behavioural therapy-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer may provide a solution. The aim is to examine the feasibility and acceptability of the intervention ENGAGE and the study procedures for a future controlled trial.Methods and analysisThe study has an uncontrolled within-group design with an embedded qualitative and quantitative process evaluation. Potential participants are parents of children previously treated for cancer, living in Sweden, recruited via their child's personal identification number (via the Swedish Childhood Cancer Registry and the Swedish Tax Agency). Parents are invited randomly with information packs sent to home addresses. Further interest in participating can be registered via information on relevant websites. The study aims to recruit 50 parents who will receive the intervention ENGAGE which is designed to be delivered over a 10-week period, and comprises one introductory chapter followed by up to 10 intervention modules addressing key concerns identified for the population. Consistent with feasibility study objectives, primary outcomes relate to recruitment, attrition, data collection, study resources, intervention delivery and acceptability. Clinical outcomes (post-traumatic stress, depression, anxiety, fear of cancer recurrence, psychological inflexibility and experiential avoidance, depressed inactivity, fatigue, quality of life and self-compassion) will be measured at baseline, post-treatment (12 weeks) and 6-month follow-up.Ethics and disseminationThe Regional Ethical Review Board in Uppsala, Sweden has granted approval for the study (Dnr: 2017/527). Results will be disseminated to relevant healthcare and patient communities, in peer-reviewed and popular science journals, and at scientific and clinical conferences.Trial registration numberISRCTN57233429; Pre-results.

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Project description:BackgroundThe U-CARE Heart trial was one of the first randomized controlled trials to evaluate the effect of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety or depression for patients with a recent myocardial infarction. While the effects of internet-based cognitive behavioral therapy on Hospital Anxiety and Depression Scale (HADS) scores at 14 weeks postbaseline were not significant, in this study, we investigated possible long-term effects of treatment.ObjectiveThe aim of this study was to evaluate the long-term effectiveness of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety and depression in patients 12 months after a myocardial infarction and to explore subsequent occurrences of cardiovascular disease events.MethodsShortly after acute myocardial infarction, 239 patients (33% female, mean age 59.6 years) reporting mild-to-moderate symptoms of anxiety or depression were randomized to 14 weeks of therapist-guided internet-based cognitive behavioral therapy (n=117) or treatment as usual (n=122). Data from national registries were used to explore group differences in clinical outcomes such as cardiovascular disease and cardiovascular-related mortality for a follow-up period of up to 5 years: group differences in HADS total score 1 year post-myocardial infarction, the primary outcome, was analyzed using multiple linear regression. Secondary outcomes, such as HADS anxiety and depression subscales and the Cardiac Anxiety Questionnaire total score (CAQ), which measures heart-focused anxiety, were analyzed in the same way. Multiple imputation was used to account for missing data, and a pooled treatment effect was estimated. Adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) for data pertaining to registry outcomes.ResultsBoth groups reported lower HADS total scores 1 year after myocardial infarction than those at baseline. HADS total scores were not significantly different between the treatment and control groups 1 year after myocardial infarction (β=-1.14, 95% CI -2.73 to 0.45, P=.16). CAQ was the only measure improved significantly by internet-based cognitive behavioral therapy when compared with treatment as usual (β=-2.58, 95% CI -4.75 to -0.42, P=.02) before adjusting for multiple comparisons. The composite outcome of nonfatal cardiovascular events and cardiovascular-related mortality did not differ between groups but was numerically higher in the internet-based cognitive behavioral therapy group, who were at slightly greater risk (HR 1.8, 95% CI 0.96 to 3.4, P=.07). Adjusting for previous myocardial infarction and diabetes attenuated this estimate (HR 1.5, 95% CI 0.8 to 2.8, P=.25).ConclusionsInternet-based cognitive behavioral therapy was not superior in reducing self-reported symptoms of depression or anxiety compared to treatment as usual at the 1-year follow-up after myocardial infarction. A reduction in cardiac-related anxiety was observed but was not significant after adjusting for multiple comparisons. There was no difference in risk of cardiovascular events between the treatment groups. Low treatment adherence, which might have affected treatment engagement and outcomes, should be considered when interpreting these results.Trial registrationClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191.International registered report identifier (irrid)RR2-10.1186/s13063-015-0689-y.

Dataset Information

Twelve-Month Follow-Up of a Randomized Controlled Trial of Internet-Based Guided Self-Help for Parents of Children on Cancer Treatment.

Background

Objective

Methods

Results

Conclusions

Publications

Twelve-Month Follow-Up of a Randomized Controlled Trial of Internet-Based Guided Self-Help for Parents of Children on Cancer Treatment.

Similar Datasets

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