Dataset Information

Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE).

ABSTRACT:

Background

Parents of children treated for cancer may experience mental health difficulties, such as depression and anxiety. There is a lack of evidence-based psychological interventions for parents, with psychological support needs unmet. An internet-administered, guided, low-intensity cognitive behavioral therapy-based (LICBT) self-help intervention may provide a solution.

Methods

The feasibility and acceptability of such an intervention was examined using a single-arm feasibility trial (ENGAGE). Primary objectives examined: (1) estimates of recruitment and retention rates; (2) feasibility and acceptability of data collection instruments and procedures; and (3) intervention feasibility and acceptability. Clinical outcomes were collected at baseline, post-treatment (12 weeks), and follow-up (6 months).

Results

The following progression criteria were met: sample size was exceeded within 5 months, with 11.0% enrolled of total population invited, study dropout rate was 24.0%, intervention dropout was 23.6%, missing data remained at ≤10% per measure, and no substantial negative consequences related to participation were reported. Intervention adherence was slightly lower than progression criteria (47.9%).

Conclusion

Findings suggest an internet-administered, guided, LICBT self-help intervention may represent a feasible and acceptable solution for parents of children treated for cancer. With minor study protocol and intervention modifications, progression to a pilot randomized controlled trial (RCT) and subsequent superiority RCT is warranted.

SUBMITTER: Thiblin E

PROVIDER: S-EPMC10028033 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE).

Thiblin Ella E Woodford Joanne J Reuther Christina C Lundgren Johan J Lutvica Nina N von Essen Louise L

Cancer medicine 20221120 5

<h4>Background</h4>Parents of children treated for cancer may experience mental health difficulties, such as depression and anxiety. There is a lack of evidence-based psychological interventions for parents, with psychological support needs unmet. An internet-administered, guided, low-intensity cognitive behavioral therapy-based (LICBT) self-help intervention may provide a solution.<h4>Methods</h4>The feasibility and acceptability of such an intervention was examined using a single-arm feasibili ...[more]

PMID: 36404407

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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.

Project description:ObjectivesDifficulties with recruitment into clinical trials are common. An opt-out recruitment strategy, whereby potential participants can decline further contact about a study (opt-out), and non-responders are contacted, may facilitate participation. Primary objectives examined opt-out and consent rates, mode and time point of opt-out, and sociodemographic characteristics of those who opted out versus those who chose to participate in a single-arm feasibility trial (ENGAGE) of a guided, internet-administered, cognitive-behavioural therapy-based intervention for parents of children treated for cancer. Secondary objectives examined reasons for non-participation.DesignA cross-sectional survey nested within the ENGAGE feasibility trial.SettingThe intervention was delivered from Uppsala University, with parents located throughout Sweden.ParticipantsPotential participants were recruited 3 months-5 years following their child ending treatment for cancer and were identified via their personal identification number (via the Swedish Childhood Cancer Registry and Swedish Tax Agency) and invited via postal invitation packs and could opt out via post, online, telephone or email. Those who did not opt out or consent, within 4 weeks, received up to five telephone calls and/or one postal reminder.ResultsOf 509 invited, 164 (32.2%) opted out, 78 (47.6%) via post, 53 (32.3%) via telephone, 24 (14.6%) online, and 6 (3.7%) via email, 88 (53.7%) opted out after at least one telephone call and/or postal reminder. There was a trend for parents with lower educational levels to opt out. No need of psychological support, lack of time, and no interest in internet-administered self-help were frequently reported reasons for non-participation.ConclusionsResults emphasise the importance of using different opt-out modes and suggest future research should consider how to widen study participation for parents with lower education levels. Self-identifying a need for psychological support and the acceptability of internet-administered self-help are important factors for participation and should be considered in future research to increase recruitment.Trial registration numberISRCTN57233429.

Project description:BackgroundThe rise in internet addiction, including web-based gaming and social networking services, is a serious concern. Even with access to medical institutions and counseling services, individuals with internet addiction, particularly adolescents, often refuse medical treatment or counseling. Parent-focused psychological intervention may lead to positive outcomes by improving the parent-adolescent relationship and helping parents identify and modify their adolescent's problematic behaviors, including internet addiction.ObjectiveThis study was a pilot randomized controlled trial to test the feasibility of remote cognitive behavioral therapy via videoconferencing for parents of adolescents with internet addiction.MethodsA total of 13 parents of adolescents aged 12-20 years with internet addiction were recruited and randomly assigned to either 12 sessions of the videoconference-delivered cognitive behavioral therapy (vCBT) group (n=6, 46%) or the waitlist control group (n=7, 54%). The study period was from March 1, 2018, to March 31, 2022. The primary outcome was the scores of the Young Internet Addiction Test reported by the adolescents. The secondary outcomes were adolescents' hours of internet use per day (Internet Addiction Test), reported by the adolescents and by their parents; the Young Diagnostic Questionnaire, completed by the parents; and the quality of life of the adolescents and the parents, measured by the EQ-5D-5L. These were evaluated at weeks 0 and 13.ResultsAs the primary outcome, the mean total Internet Addiction Test score decreased from 67.7 (SD 18.3; 6/13, 46%) at week 0 to 56.2 (SD 25.1; 5/9, 56%) at week 13 in the vCBT group, compared to an increase from 66.9 (SD 21.9; 7/13, 54%) to 68.0 (SD 18.7; 4/9, 44%) in the control group. For all outcomes, no significant differences were found between the 2 groups (all P>.05).ConclusionsThis study suggested the practical feasibility of vCBT for parents of adolescents with internet addiction. Further large-scale, multicenter randomized controlled trials are necessary to examine the effectiveness.Trial registrationUMIN Clinical Trials Registry UMIN000032483; https://tinyurl.com/yuhen6c9.

Project description:BACKGROUND:Pain-related functional gastrointestinal disorders (P-FGIDs; eg, irritable bowel syndrome) are highly prevalent in children and associated with low quality of life, anxiety, and school absence. Treatment options are scarce, and there is a need for effective and accessible treatments. Internet-delivered cognitive behavior therapy (Internet-CBT) based on exposure exercises is effective for adult and adolescent irritable bowel syndrome, but it has not been evaluated for younger children. OBJECTIVE:The objective of this study was to assess acceptability, feasibility, and potential clinical efficacy of Internet-CBT for children with P-FGIDs. METHODS:This was a feasibility study with a within-group design. We included 31 children aged 8-12 years and diagnosed with P-FGID, according to the ROME III criteria. Mean duration of abdominal symptoms at baseline was 3.8 years (standard deviation [SD] 2.6). The treatment was therapist-guided and consisted of 10 weekly modules of exposure-based Internet-CBT. The children were instructed to provoke abdominal symptoms in a graded manner and to engage in previously avoided activities. The parents were taught to decrease their attention to their children's pain behaviors and to reinforce and support their work with the exposures. Assessments included treatment satisfaction, subjective treatment effect, gastrointestinal symptoms, quality of life, pain intensity, anxiety, depression, and school absence. Data were collected at pretreatment, posttreatment, and 6-month follow-up. Means, standard errors (SEs), and Cohen d effect sizes were estimated based on multi-level linear mixed models. RESULTS:Most children 25/31 (81%) completed 9 or 10 of the 10 treatment modules. Almost all children, 28/31 (90%), reported that the treatment had helped them to deal more effectively with their symptoms, and 27/31 (87%) children declared that their symptoms had improved during the treatment. Assessments from the parents were in accordance with the children's reports. No child or parent reported that the symptoms had worsened. We observed a large within-group effect size on the primary outcome measure, child-rated gastrointestinal symptoms from pretreatment to posttreatment (Cohen d=1.14, P<.001, 95% CI 0.69-1.61), and this effect size was maintained at 6-month follow-up (Cohen d=1.40, P<.001, 95% CI 1.04-1.81). We also observed significant improvements from pretreatment to posttreatment on a wide range of child- and parent-rated measures including quality of life, pain intensity, anxiety, depression, and school absence. All results remained stable or were further improved at 6-month follow-up. CONCLUSIONS:This study shows that children with longstanding P-FGIDs, and their parents, perceive exposure-based Internet-CBT as a helpful and feasible treatment. The included children improved significantly despite a long duration of abdominal symptoms before the intervention. The treatment shows potential to be highly effective for P-FGIDs. The results need to be confirmed in a randomized controlled trial (RCT).

Project description:BackgroundInternet-based cognitive behavioral therapy (iCBT) for child and adolescent anxiety has demonstrated efficacy in randomized controlled trials, but it has not yet been examined when disseminated as a public health intervention. If effective, iCBT programs could be a promising first-step, low-intensity intervention that can be easily accessed by young people.ObjectiveThe objective of our study was to examine the feasibility and acceptability of a publicly available online, self-help iCBT program (BRAVE Self-Help) through exploration of program adherence, satisfaction, and changes in anxiety.MethodsThis study was an open trial involving the analysis of data collected from 4425 children and adolescents aged 7-17 years who presented with elevated anxiety at registration (baseline) for the iCBT program that was delivered through an open-access portal with no professional support. We assessed the program satisfaction via a satisfaction scale and measured adherence via the number of completed sessions. In addition, anxiety severity was assessed via scores on the Children's Anxiety Scale, 8-item (CAS-8) at four time points: baseline, Session 4, Session 7, and Session 10.ResultsParticipants reported moderate satisfaction with the program and 30% completed three or more sessions. Statistically significant reductions in anxiety were evident across all time points for both children and adolescents. For users who completed six or more sessions, there was an average 4-point improvement in CAS-8 scores (Cohen d=0.87, children; Cohen d=0.81, adolescents), indicating a moderate to large effect size. Among participants who completed nine sessions, 57.7% (94/163) achieved recovery into nonelevated levels of anxiety and 54.6% (89/163) achieved statistically reliable reductions in anxiety.ConclusionsParticipant feedback was positive, and the program was acceptable to most young people. Furthermore, significant and meaningful reductions in anxiety symptoms were achieved by many children and adolescents participating in this completely open-access and self-directed iCBT program. Our results suggest that online self-help CBT may offer a feasible and acceptable first step for service delivery to children and adolescents with anxiety.

Dataset Information

Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE).

Background

Methods

Results

Conclusion

Publications

Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE).

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