Dataset Information

Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial.

ABSTRACT:

Introduction

Grief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive-behavioural therapy, iCBT) are a cost-effective alternative that makes it possible to reach more people with PGD. The main aim of this study is to assess the feasibility of a new iCBT-called GROw-for PGD. As a secondary objective, the potential effectiveness of GROw will be explored.

Methods and analysis

This study is a two-arm feasibility randomised trial. A total of 48 adults with PGD who meet the eligibility criteria will be randomised to the experimental group (iCBT: GROw) or the active control group (face-to-face CBT treatment). The treatment is organised sequentially in eight modules in the iCBT format and 8-10 sessions in the face-to-face format, and both formats have the same therapeutic components. There will be five assessment points with qualitative and quantitative evaluations: screening, baseline, after the intervention, 3-month follow-up and 12-month follow-up. Consistent with the objectives, the measures are related to the feasibility outcomes for the main aim of the study (participant adherence, expectations and satisfaction with the treatment, preferences, alliance and utility) and psychological and mental health outcomes for secondary analyses (symptoms of grief, symptoms of depression, symptoms of anxiety, affectivity, quality of life, work and social adaptation, post-traumatic growth, purpose in life, mindfulness and compassion).

Ethics and dissemination

The Ethics Committee of the Universitat Jaume I (Castellón, Spain) granted approval for the study (CD/002/2019). Dissemination will include publications and presentations at national and international conferences.

Trial registration number

NCT04462146.

SUBMITTER: Tur C

PROVIDER: S-EPMC8261880 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Prolonged grief disorder (PGD) has emerged as a well-defined and relatively common mental disorder that will be included in the upcoming revision of the International Classification of Diseases. Recent trials with grief-specific, mostly cognitive behavioral interventions for patients with a clinically relevant diagnosis of PGD showed large effect sizes. However, a small trial suggested that non-specific behavioral activation might suffice to improve PGD. So, more evidence for the relative efficacy of grief-specific treatments is needed, as is more research on the predictors of treatment success. The purpose of the proposed trial is to evaluate a newly developed and successfully pilot-tested, prolonged grief-specific, integrative cognitive behavioral therapy (PG-CBT) compared to an active yet unspecific treatment, present-centered therapy (PCT). METHODS:In a multicenter, randomized controlled trial with 204 adults with a primary diagnosis of PGD, PG-CBT is compared to PCT, assuming the superiority of PG-CBT. Both treatments consist of 20 to 24 individual sessions, with an overall treatment length of about 6 months. The primary outcome, grief symptom severity, is assessed by blinded interviewers 12 months after randomization. Secondary outcomes are grief symptom severity at post treatment, in addition to self-reported overall mental health symptoms, depressive and somatoform symptoms at post treatment and 12 months post randomization. Possible moderators and mediators of treatment success are also explored. DISCUSSION:The trial is designed to avoid bias as much as possible (stratified randomization performed independently, blinded outcome assessment, intention-to-treat-analysis, balanced treatment dose, continuous supervision, control for allegiance effects) thereby enhancing internal validity. At the same time, some aspects of the trial will ensure clinical relevance (recruiting at outpatient clinics that are part of routine health care and keeping exclusion criteria to a minimum). Since the trial is powered adequately for the primary outcome, all secondary analyses including moderator analyses are exploratory by nature. The results will extend the knowledge on efficacious treatment of PGD and its predictors. TRIAL REGISTRATION:German Clinical Trials Register, ID: DRKS00012317 . Registered on 6 September 2017.

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:ObjectivesCognitive behavioral therapy (CBT) is the most promising treatment for gambling disorder (GD) but only 21% of those with problematic gambling seek treatment. CBT over the Internet might be one way to reach a larger population. The aim of this study was to assess the effectiveness of Internet-delivered CBT with therapist guidance compared to an active control treatment.MethodsUsing a single-blinded design, 71 treatment-seeking gamblers (18-75 years) diagnosed with GD were randomized to 8 weeks of Internet-delivered CBT guided by telephone support, or 8 weeks of Internet-delivered motivational enhancement paired with motivational interviewing via telephone (IMI). The primary outcome was gambling symptoms measured at a first face-to-face assessment, baseline (treatment start), every 2 weeks, post-treatment, and 6-month follow-up. Gambling expenditures, time spent gambling, depression, anxiety, cognitive distortions, and quality of life were assessed as secondary outcomes. Analysis was performed on the full analysis sample (n = 60), with intention-to-treat sensitivity analyses (n = 69).ResultsIn the CBT group, 80% stayed in treatment until the final week, compared to 67% in IMI. Post-treatment and at 6-month follow-up, no differences were found between CBT and IMI for any outcome measure. An exploratory analysis of the total sample (n = 60) showed a significant effect of time during treatment on gambling symptoms (d, [95% CI] 0.52, [-1.15, 2.02]) and all secondary outcomes except the gambling diary (depression (0.89, [-1.07-2.65]); anxiety (0.69, [-1.20-2.38])); cognitive distortions (0.84, [-0.73-2.29]); quality of life (0.60, [-0.61-1.70])). Post-treatment, there were no clinical gambling symptoms in either group. Some deterioration was seen between post-treatment and 6-month follow-up on gambling symptoms (0.42, [-1.74-2.43]), depression (0.59, [-0.82-1.86]), and anxiety (0.30, [-0.99-1.48]). Additionally, it was observed that the largest reduction in gambling symptoms was between the first assessment and baseline.ConclusionBoth treatments offered in this study were effective at reducing gambling symptoms. It is also possible that the process of change started before treatment, which gives promise to low-intensity interventions for GD. Additional research is needed as this approach could be both cost-effective and has the potential to reach more patients in need of treatment than is currently possible.Clinical trial registrationhttps://www.isrctn.com/, identifier ISRCTN38692394.

Project description:Background and aimsInternet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania).MethodsParticipants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures.ResultsA significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later.ConclusionsInternet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania.Trial registrationClinicalTrials.gov NCT01557894.

Project description:ImportanceSocial anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited.ObjectiveTo assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT).Design, setting, and participantsThis single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study.InterventionsICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist.Main outcomes and measuresThe Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs.ResultsOf the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group.Conclusions and relevanceIn this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD.Trial registrationClinicalTrials.gov Identifier: NCT03247075.