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Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Rosner R

PROVIDER: S-EPMC5910599 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial.

Rosner Rita R Rimane Eline E Vogel Anna A Rau Jörn J Hagl Maria M

Trials 20180420 1

<h4>Background</h4>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 ...[more]

PMID: 29678193

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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:ObjectivesProlonged grief disorder is associated with significant distress and impairment and thus efforts to improve treatments are essential. The present pilot study tested the efficacy and feasibility of group Metacognitive Grief Therapy (MCGT) designed specifically for prolonged grief symptomatology to reduce the psychological distress and impaired function resulting from bereavement.Design/participantsTwenty-two bereaved adult participants with prolonged grief symptomatology were randomised to a wait-list control (n=10) or an intervention condition (n=12) with a 3-month and 6-month follow-up. The wait-list control group was offered treatment after the post-test assessment.InterventionParticipants attended six group MCGT sessions that ran for 2 hours per week.Outcome measuresA primary outcome measure of prolonged grief symptomatology and secondary outcome measures of depression, anxiety, rumination, metacognitive beliefs and quality of life were taken pretreatment and post-treatment for both groups and at the 3-month and 6-month follow-up for the intervention group. A Generalised Linear Mixed Model was used to assess treatment efficacy.ResultsPost-treatment intent-to-treat analyses showed MCGT reduced prolonged grief symptomatology (Cohen's d=1.7), depression (d=1.3), anxiety (d=0.8), stress (d=1.0), rumination (d=0.9) and increased quality of life (d=0.6), and these effects were maintained at the 3-month and 6-month follow-ups. No prepost between-group differences were found in metacognitive beliefs. However, a large significant effect was identified at the 3-month and 6-month follow-ups (d=1.0).ConclusionThe results show promise for the utility of group MCGT for reducing psychological distress and promoting quality of life. Additionally, the results underscore the need for a full randomised controlled trial of group MCGT, which may be an important addition to the treatment armamentarium available to support people with prolonged grief.Trial registration numberACTRN12613001270707; Results. ORIGINAL PROTOCOL: BMJ Open 2015;5:e007221. doi:10.1136/bmjopen-2014-007221.

Project description:BackgroundAttention-deficit hyperactivity disorder (ADHD) is a mental disorder beginning in childhood, and about half of patients have symptoms lasting into adulthood. Adult ADHD causes various impairments of emotional, self-esteem, and executive function and life quality aspects. Furthermore, adverse outcomes include academic and occupational failures, traffic accidents and substance abuse, which would be a family and social burden. A combination of medication and psychotherapy is recommended as the treatment for adult ADHD, and cognitive behavioral therapy (CBT) has been validated mostly with evidence-based researches. However, there has been a lack of randomized controlled trials of CBT for patients in China. Moreover, booster sessions of CBT for other disorders have proven effective in reducing recurrence and improving long-term outcomes, which has not been investigated for adult ADHD. This study will testify to the effect of CBT and explore the efficacy of subsequent booster sessions on adult ADHD.Methods/designIt is a three-armed randomized controlled trial to evaluate the efficacy of 12 weeks of CBT based on the published and validated manual and its booster sessions. The 12 weeks of CBT will be conducted weekly and will end at the 12th week, and then the booster sessions will be conducted monthly and end at the 24th week. There are three randomized groups, including a CBT with booster sessions group, a CBT group and a waiting group. Participants are outpatients of the Peking University Sixth Hospital who are diagnosed as having adult ADHD. The Primary efficacy endpoints are the scores of ADHD core symptoms at 12 and 24 weeks. Secondary endpoints include emotion, executive function, self-esteem, life quality and functional magnetic resonance imaging (fMRI) data at different time points, and the change within every group will also be analyzed.DiscussionThis is the first study to explore the efficacy of booster sessions of CBT in adult ADHD as far as we know. The results might increase proof of efficacy of CBT for adult ADHD in China, and the results showing efficacy of the booster sessions would also benefit our clinical practice.Trial registrationCurrent Controlled Trials: NCT02062411, date of registration: 12 February 2014.

Project description:Present-centered therapy (PCT) was originally developed as a strong comparator for the non-specific effects of psychotherapy in the treatment of posttraumatic stress disorder. PCT qualifies as a not strictly supportive treatment as it is structured and homework is assigned between sessions. It does not focus on cognitive restructuring or exposure. A growing body of literature supports its beneficial effects. For example, it demonstrated only slightly inferior effect sizes and lower dropout rates compared to that of trauma-focused cognitive behavioral therapy in several trials with patients suffering from posttraumatic stress disorder. The current study is the first to evaluate the feasibility and the treatment effects of PCT in adults with prolonged grief disorder (PGD). Meta-analyses on psychotherapy for PGD have yielded moderate effect sizes. N = 20 individuals suffering from PGD were treated with PCT by novice therapists as part of a preparation phase for an upcoming RCT in an outpatient setting. Treatment consisted of 20-24 sessions á 50 min. All outcomes were assessed before treatment, at post-treatment, and at the 3-month follow-up. The primary outcome, PGD symptom severity, was assessed using the Interview for Prolonged Grief-13. Secondary outcomes were self-reported PGD severity, depression, general psychological distress, and somatic symptom severity. Furthermore, therapists evaluated their experiences with their first PCT patient and the treatment manual. In intent-to-treat analyses of all patients we found a significant decrease in interview-based PGD symptom severity at post-treatment (d = 1.26). Decreases were maintained up to the 3-month follow-up assessment (d = 1.25). There were also significant decreases in self-reported PGD symptoms, depression, and general psychological distress. No changes were observed for somatic symptoms. The completion rate was 85%. Therapists deemed PCT to be a learnable treatment program that can be adapted to the patient's individual needs. The preliminary results of PCT as a treatment for PGD demonstrate large effects and indicate good feasibility in outpatient settings. The treatment effects were larger than those reported in meta-analyses. Thus, PCT is a promising treatment for PGD. Possible future research directions are discussed.

Project description:BackgroundBereavement 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.ObjectiveThe 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.MethodsThe 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.ResultsA 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.ConclusionsThe 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 registrationGerman Clinical Trial Register U1111-1186-6255; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011001.

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.

Dataset Information

Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial.

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Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial.

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