Dataset Information

Therapist-Assisted Web-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement: Randomized Controlled Trial.

ABSTRACT:

Background

Bereavement due to cancer increases the risk of prolonged grief disorder. However, specialized treatment options for prolonged grief after a loss due to illness are still scarce.

Objective

The aim of this study is to extend previous findings by evaluating a web-based cognitive behavioral intervention with asynchronous therapist support, consisting of structured writing tasks adapted specifically for prolonged grief after cancer bereavement.

Methods

The intervention was evaluated in a purely web-based randomized waitlist-controlled trial. Open-access recruitment of participants was conducted on the web. Prolonged grief (Inventory of Complicated Grief), depression, anxiety, posttraumatic stress, posttraumatic growth, somatization, sleep quality, and mental and physical health were assessed on the web via validated self-report measures.

Results

A total of 87 participants were randomized into the intervention group (IG; 44/87, 51%) or the waitlist control group (43/87, 49%). Of the participants, 7% (6/87) dropped out of the study (5/44, 11%, in the IG). Of the 39 completers in the IG, 37 (95%) completed all intervention tasks. The intervention reduced symptoms of prolonged grief (intention-to-treat: P<.001; η²=0.34; Cohen d=0.80) to a clinically significant extent. It had favorable effects on depression, anxiety, posttraumatic stress, posttraumatic growth, and overall mental health but not on somatization, sleep quality, or physical health.

Conclusions

The web-based intervention for prolonged grief after cancer bereavement is effective in reducing symptoms of prolonged grief disorder and accompanying syndromes in a timely, easily realizable manner and addresses specific challenges of bereavement to illness. Considering web-based approaches in future mental health care policy and practice can reduce health care gaps for those who are bereaved to cancer.

Trial registration

German Clinical Trial Register U1111-1186-6255; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011001.

SUBMITTER: Kaiser J

PROVIDER: S-EPMC8864524 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Therapist-Assisted Web-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement: Randomized Controlled Trial.

Kaiser Julia J Nagl Michaela M Hoffmann Rahel R Linde Katja K Kersting Anette A

JMIR mental health 20220208 2

<h4>Background</h4>Bereavement due to cancer increases the risk of prolonged grief disorder. However, specialized treatment options for prolonged grief after a loss due to illness are still scarce.<h4>Objective</h4>The aim of this study is to extend previous findings by evaluating a web-based cognitive behavioral intervention with asynchronous therapist support, consisting of structured writing tasks adapted specifically for prolonged grief after cancer bereavement.<h4>Methods</h4>The interventi ...[more]

PMID: 35133286

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Project description:BackgroundProlonged grief disorder (PGD) is a newly recognized mental disorder characterized by pervasive intense grief that persists longer than cultural or social expectations and interferes with functioning. The COVID-19 epidemic has resulted in increased rates of PGD, and few clinicians feel confident in treating this condition. PGD therapy (PGDT) is a simple, short-term, and evidence-based treatment developed in tandem with the validation of the PGD diagnosis. To facilitate the dissemination of PGDT training, we developed a web-based therapist tutorial that includes didactic training on PGDT concepts and principles as well as web-based multimedia patient scenarios and examples of clinical implementation of PGDT.ObjectiveWe aimed to evaluate user satisfaction with the tutorial and whether the tutorial increased trainees' knowledge of PGDT principles and procedures. Moreover, we included a small number of pilot questions to evaluate the PGDT-related clinical skills.MethodsThis study evaluated tutorial learning using a pre- and poststudy design. Participants were recruited from professional organization mailing lists, announcements to graduates of the Columbia School of Social Work, and through word of mouth. After signing consent, participants completed a brief demographic survey, a 55-item multiple-choice prestudy test on the concepts and principles of PGD and PGDT covered in the tutorial, and a 4-item pilot web-based prestudy test to gauge PGD clinical implementation skills. The link to the course content was then activated, and participants were given 8 weeks to complete the 11-module tutorial containing information, web-based exercises, simulated patient and video examples, and self-tests.ResultsOverall, 406 clinicians signed consent, and 236 (58.1%) started the tutorial. Of these, 83.1% (196/236) completed all 11 modules. Trainee scores on our PDGT assessment improved substantially from pretraining to the postmodule assessment, with the total number of correct answers increasing from a mean of 29 (SD 5.5; 52.7% correct) to 36.7 (SD 5.2; 66.7% correct; t195=18.93; P<.001). In addition, the trainee's implementation scores on 4 clinical vignettes increased from 2.6 (SD 0.7) correct out of 4 to 3.1 (SD 0.4) out of 4 (t188=7.02; P<.001). Effect sizes (Cohen d) were 1.44 (95% CI 1.23-1.65) for PDGT assessment and 1.06 (95% CI 0.84-1.29) for implementation. Trainees found the tutorial interesting, enjoyable, clearly presented, and useful for professional development. They endorsed a mean score of 3.7 (SD 0.47) on a 1 to 4 scale of agreement with recommending the course to others and feeling satisfied with the tutorial, and a mean of 3.3 (SD 0.57) with feeling able to apply the skills with clients.ConclusionsThis pilot study provides support for the usefulness of this web-based training for teaching clinicians how to administer PGDT. The addition of patient scenarios for clinical implementation strategies holds promise for increasing the effectiveness of PGDT training and other evidence-based treatments.Trial registrationClinicalTrials.gov NCT05121792; https://www.clinicaltrials.gov/ct2/show/NCT05121792.

Project description:BackgroundProlonged 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).MethodsIn 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.DiscussionThe 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 registrationGerman Clinical Trials Register, ID: DRKS00012317 . Registered on 6 September 2017.

Project description:BackgroundLosing a loved one, through death or separation, counts among the most stressful life events and is detrimental to health and well-being. About 15% of people show clinically significant difficulties coping with such an event. Web-based interventions (WBIs) are effective for a variety of mental health disorders, including prolonged grief. However, no validated WBI is available in French for treating prolonged grief symptoms.ObjectiveThis study aimed to compare the efficacy and adherence rates of 2 WBIs for prolonged grief symptoms following the loss of a loved one through death or romantic separation.MethodsLIVIA 2.0 was developed relying on theoretical and empirical findings on bereavement processes and WBIs, and is compared with LIVIA 1, which has already demonstrated its efficacy. We conducted a randomized controlled trial and provided on-demand guidance to participants. Outcomes were assessed through web-based questionnaires before the intervention, after the intervention (12 weeks later), and at follow-up (24 weeks later). Primary outcomes were grief symptoms, depressive symptoms, and well-being. Secondary outcomes were anxiety symptoms, grief coping strategies, aspects related to self-identity, and program satisfaction.ResultsIn total, 62 participants were randomized (intent-to-treat [ITT] sample), 29 (47%) in LIVIA 2.0 (active arm) and 33 (53%) in LIVIA 1 (control arm). The dropout rate was 40% (37/62), and 10 participants were removed due to exclusion criteria, leading to a final per-protocol sample of 27 (44%) completers who differed from noncompleters only based on reporting fewer anxiety symptoms (t60=3.03; P=.004). Participants who are separated reported more grief symptoms (t60=2.22; P=.03) and attachment anxiety (t60=2.26; P=.03), compared to participants who are bereaved. There were pre-post within-group differences for both programs in the ITT sample, with significant reductions in grief (Cohen d=-0.90), depressive symptoms (Cohen d=-0.31), and centrality of the loss (Cohen d=-0.45). The same pattern was observed in the per-protocol sample, with the exception that anxiety symptoms also significantly diminished (Cohen d=-0.45). No difference was found in efficacy between the 2 programs (all P>.33). Participants (ITT sample) reported overall high levels of program satisfaction (mean 3.18, SD 0.54; over a maximum of 4). Effect stability was confirmed at the 6-month follow-up for all outcomes, with an improvement in self-concept clarity.ConclusionsThe 2 grief-related WBIs were effective in reducing grief, depressive and anxiety symptoms for participants who are bereaved or separated. The analyses did not reveal any pre-post between-group differences, suggesting that the innovations brought to LIVIA 2.0 did not significantly affect the outcome. However, caution is warranted with the interpretation of the results given the limited power of the sample, which only allows the detection of medium effect sizes.Trial registrationClinicalTrials.gov NCT05219760; https://clinicaltrials.gov/study/NCT05219760.International registered report identifier (irrid)RR2-10.2196/39026.

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:BackgroundThere is a lack of effective pharmacotherapy for prolonged grief disorder (PGD). Evidence suggests that the neurobiology of PGD involves the same circuitry as the reward pathway. Based upon this evidence, we hypothesize that PGD can be conceptualized as a disorder of addiction and therefore could benefit from being treated with medications that are currently used to treat such disorders. One such medication is naltrexone, which is currently used to treat alcohol and opioid dependence. Oral naltrexone was chosen for its mechanism of action, safety, and convenience. The primary aim of this study is to establish the efficacy of using oral naltrexone as a pharmacological treatment for PGD. Specifically, we hypothesize that participants receiving naltrexone will demonstrate reduced PGD symptoms when compared to placebo.Methods/designThis is a randomized, placebo-controlled, triple-blinded (to healthcare professionals/study staff, participants, and data analysts) study in which we propose to enroll 48 participants who meet criteria for Prolonged Grief Disorder (PGD). Participants will be randomly assigned to the naltrexone 50 mg oral arm or placebo arm; medications will be over-encapsulated to appear identical. Participants will take their assigned medication for 8 weeks, with clinic visits every 4 weeks to assess symptom severity, social closeness, and adverse reactions. Weekly surveys of Prolonged Grief-13-Revised (PG-13-R) will be used to relate naltrexone use to changes in PGD symptom severity. Follow-up 4 weeks after their last visit will assess the longevity of treatment, as well as any lingering adverse reactions.DiscussionThis study is the first to investigate the use of oral naltrexone as pharmacological treatment for PGD. The acute and debilitating nature of the disorder, in addition to the increased risk of comorbidities, highlights the need for pharmacological treatment like naltrexone that can act more rapidly, may help those for whom psychotherapy may not be effective, and/or may augment psychotherapy to promote PGD symptom grief resolution.Trial registrationClinicalTrials.gov NCT04547985 . Registered on 8/31/2020.

Project description:BackgroundObsessive-compulsive disorder (OCD) is a highly disabling psychological disorder with a chronic course if left untreated. Cognitive behavioral therapy (CBT) has been shown to be an effective treatment, but access to face-to-face CBT is not always possible. Internet-based CBT (iCBT) has become an increasingly viable option. However, no study has compared iCBT to an analogous control condition using a randomized controlled trial (RCT).ObjectiveA 2-armed RCT was used to compare a therapist-assisted 12-module iCBT to an analogous active attention control condition (therapist-assisted internet-based standard progressive relaxation training, iPRT) in adult OCD. This paper reports pre-post findings for OCD symptom severity.MethodIn total, 179 participants (117 females, 65.7%) were randomized (stratified by gender) into iCBT or iPRT. The iCBT intervention included psychoeducation, mood and behavioral management, exposure and response prevention (ERP), cognitive therapy, and relapse prevention; the iPRT intervention included psychoeducation and relaxation techniques as a way of managing OCD-related anxiety but did not incorporate ERP or other CBT elements. Both treatments included audiovisual content, case stories, demonstrations of techniques, downloadable audio content and worksheets, and expert commentary. All participants received 1 weekly email, with a maximum 15-minute preparation time per client from a remote therapist trained in e-therapy. Emails aimed to monitor progress, provide support and encouragement, and assist in individualizing the treatment. Participants were assessed for baseline and posttreatment OCD severity with the telephone-administered clinician-rated Yale-Brown Obsessive-Compulsive Scale and other measures by assessors who were blinded to treatment allocation.ResultsNo pretreatment differences were found between the 2 conditions. Intention-to-treat analysis revealed significant pre-post improvements in OCD symptom severity for both conditions (P<.001). However, relative to iPRT, iCBT showed significantly greater symptom severity improvement (P=.001); Cohen d for iCBT was 1.05 (95% CI 0.72-1.37), whereas for iPRT it was 0.48 (95% CI 0.22-0.73). The iCBT condition was superior in regard to reliable improvement (25/51, 49% vs 16/55, 29%; P=.04) and clinically significant pre-post-treatment changes (17/51, 33% vs 6/55, 11%; P=.005). Those undertaking iCBT post completion of iPRT showed further significant symptom amelioration (P<.001), although the sequential treatment was no more efficacious than iCBT alone (P=.63).ConclusionThis study is the first to compare a therapist-assisted iCBT program for OCD to an analogous active attention control condition using iPRT. Our findings demonstrate the large magnitude effect of iCBT for OCD; interestingly, iPRT was also moderately efficacious, albeit significantly less so than the iCBT intervention. The findings are compared to previous internet-based and face-to-face CBT treatment programs for OCD. Future directions for technology-enhanced programs for the treatment of OCD are outlined.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000321943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336704 (Archived by WebCite at http://www.webcitation.org/70ovUiOmd).

Project description:BackgroundBereaved ICU family surrogates are at risk of comorbid prolonged grief disorder (PGD), posttraumatic stress disorder (PTSD), and depression. Knowledge about temporal relationships between PGD, PTSD, and depression is limited by a lack of relevant studies and diverse or inappropriate assessment time frames given the duration criterion for PGD. We aimed to determine the temporal reciprocal relationships between PGD, PTSD, and depressive symptoms among ICU decedents' family surrogates during their first 2 bereavement years with an assessment time frame reflecting the PGD duration criterion.MethodsThis prospective, longitudinal, observational study examined PGD, PTSD, and depressive symptoms among 303 family surrogates of ICU decedents from two academic hospitals using 11 items of the Prolonged Grief Disorder-13, the Impact of Event Scale-Revised, and the depression subscale of the Hospital Anxiety and Depression Scale, respectively, at 6, 13, 18, and 24 months post-loss. Cross-lagged panel modeling was conducted: autoregressive coefficients indicate variable stability, and cross-lagged coefficients indicate the strength of reciprocal relationships among variables between time points.ResultsSymptoms (autoregressive coefficients) of PGD (0.570-0.673), PTSD (0.375-0.687), and depression (0.591-0.655) were stable over time. Cross-lagged standardized coefficients showed that depressive symptoms measured at 6 months post-loss predicted subsequent symptoms of PGD (0.146) and PTSD (0.208) at 13 months post-loss. PGD symptoms did not predict depressive symptoms. PTSD symptoms predicted subsequent depressive symptoms in the second bereavement year (0.175-0.278). PGD symptoms consistently predicted subsequent PTSD symptoms in the first 2 bereavement years (0.180-0.263), whereas PTSD symptoms predicted subsequent PGD symptoms in the second bereavement year only (0.190-0.214). PGD and PTSD symptoms are bidirectionally related in the second bereavement year.ConclusionsPGD, PTSD, and depressive symptoms can persist for 2 bereavement years. Higher PGD symptoms at 6 months post-loss contributed to the exacerbation of PTSD symptoms over time, whereas long-lasting PTSD symptoms were associated with prolonged depression and PGD symptoms beyond the first bereavement year. Identification and alleviation of depression and PGD symptoms as early as 6 months post-loss enables bereaved surrogates to grieve effectively and avoid the evolution of those symptoms into long-lasting PGD, PTSD, and depression.

Dataset Information

Therapist-Assisted Web-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement: Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Therapist-Assisted Web-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement: Randomized Controlled Trial.

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