Effectiveness of a Videoconferencing-Delivered Psychological Intervention for Mental Health Problems during COVID-19: A Proof-of-Concept Randomized Clinical Trial.

INTRODUCTION: Anxiety and depression have increased markedly during the COVID-19 pandemic. There is a lack of evidence-based strategies to address these mental health needs during the pandemic. OBJECTIVE: We aim to conduct a proof-of-concept trial of the efficacy of a brief group-based psychological intervention delivered via videoconferencing for adults in Australia distressed by the pandemic. METHODS: In this single-blind, parallel, randomised controlled trial, adults who screened positive for COVID-related psychological distress across Australia were randomly allocated to either a 6-session group-based program based on behavioural principles (n = 120) or enhanced usual care (EUC, n = 120). Primary outcome was total score on the Hospital Anxiety and Depression (HADS) anxiety and depression subscales assessed at baseline, 1 week posttreatment, 2 months (primary outcome time point), and 6 months after treatment, as well as secondary outcome measures of worry, sleep impairment, anhedonia, mood, and COVID-19-related stress. RESULTS: Between May 20, 2020, and October 20, 2020, 240 patients were enrolled into the trial. Relative to EUC, at 2 months participants receiving intervention showed greater reduction on anxiety (mean difference, 1.4 [95% CI, 0.3 to 2.6], p = 0.01; effect size, 0.4 [95% CI, 0.1 to 0.7]) and depression (mean difference, 1.6 [95% CI, 0.4 to 2.8], p = 0.009; effect size, 0.4 [95% CI, 0.2 to 0.7]) scales. These effects were maintained at 6 months. There were also greater reductions of worry, anhedonia, COVID-19-related fears, and contamination fears. CONCLUSIONS: This trial provides initial evidence that brief group-based behavioural intervention delivered via videoconferencing results in moderate reductions in common psychological problems arising during the COVID-19 pandemic. This program may offer a viable and scalable means to mitigate the rising mental health problems during the pandemic.

Two-year follow-up of trauma-focused cognitive behavior therapy for posttraumatic stress disorder in emergency service personnel: A randomized clinical trial.

BACKGROUND: Emergency service personnel experience elevated rates of posttraumatic stress disorder (PTSD). There are few controlled trials for PTSD in this population, and none report longer term effects of treatment. This study evaluated the benefits of cognitive behavior therapy (CBT) for PTSD in emergency service personnel who received either brief exposure (CBT-B) to trauma memories or prolonged exposure (CBT-L) 2 years following treatment. METHODS: One hundred emergency service personnel with PTSD were randomized to CBT-L, CBT-B, or Wait-List (WL). Following posttreatment assessment, WL participants were randomized to an active treatment. Participants randomized to CBT-L or CBT-B were assessed at baseline, posttreatment, 6-month, and 2-year follow-up. Both CBT conditions involved 12 weekly individual sessions comprising education, CBT skills building, imaginal exposure, in vivo exposure, cognitive restructuring, and relapse prevention. Reliving trauma memories occurred for 40 min per session in CBT-L and for 10 min in CBT-B. RESULTS: At the 2-year follow-up, there were no differences in PTSD severity (Clinician Administered PTSD Scale) between CBT-L and CBT-B. There were very large effect sizes for CBT-L (1.28, 95% confidence interval [CI] = 0.90-1.64) and CBT-B (1.28, 95% CI = 0.05-1.63) from baseline to 2-year follow-up. CONCLUSIONS: This study highlights that CBT can be an effective treatment of PTSD in emergency service personnel using either prolonged or brief periods of reliving the trauma memory, and that these benefits can last for at least 2 years after treatment.

Efficacy of exposure-based cognitive behaviour therapy for post-traumatic stress disorder in emergency service personnel: a randomised clinical trial.

BACKGROUND: Although emergency service personnel experience markedly elevated the rates of post-traumatic stress disorder (PTSD), there are no rigorously conducted trials for PTSD in this population. This study assessed the efficacy of cognitive behaviour therapy (CBT) for PTSD in emergency service personnel, and examined if brief exposure (CBT-B) to trauma memories is no less efficacious as prolonged exposure (CBT-L). METHOD: One hundred emergency service personnel with PTSD were randomised to either immediate CBT-L, CBT-B or wait-list (WL). Following post-treatment assessment, WL participants were randomised to an active treatment. Participants randomised to CBT-L or CBT-B were assessed at baseline, post-treatment and at 6-month follow-up. Both CBT conditions involved 12 weekly individual sessions comprising education, CBT skills building, imaginal exposure, in vivo exposure, cognitive restructuring and relapse prevention. Imaginal exposure occurred for 40 min per session in CBT-L and for 10 min in CBT-B. RESULTS: At post-treatment, participants in WL had smaller reductions in PTSD severity (Clinician Administered PTSD Scale), depression, maladaptive appraisals about oneself and the world, and smaller improvements on psychological and social quality of life than CBT-L and CBT-B. There were no differences between CBT-L and CBT-B at follow-up on primary or secondary outcome measures but both CBT-L and CBT-B had large baseline to follow-up effect sizes for reduction of PTSD symptoms. CONCLUSIONS: This study highlights that CBT, which can include either long or brief imaginal exposure, is efficacious in reducing PTSD in emergency service personnel.

Cognitive Behavior Therapy vs Mindfulness in Treatment of Prolonged Grief Disorder: A Randomized Clinical Trial.

Importance: Although grief-focused cognitive behavior therapies are the most empirically supported treatment for prolonged grief disorder, many people find this treatment difficult. A viable alternative for treatment is mindfulness-based cognitive therapy. Objective: To examine the relative efficacies of grief-focused cognitive behavior therapy and mindfulness-based cognitive therapy to reduce prolonged grief disorder severity. Design, Setting, and Participants: A single-blind, parallel, randomized clinical trial was conducted among adults aged 18 to 70 years with prolonged grief disorder, as defined in the International Classification of Diseases, 11th Revision, and assessed by clinical interview based on the Prolonged Grief-13 (PG-13) scale. Those with severe suicidal risk, presence of psychosis, or substance dependence were excluded. Between November 2012 and November 2022, eligible participants were randomized 1:1 to eleven 90-minute sessions of grief-focused cognitive behavior therapy or mindfulness-based cognitive therapy at a traumatic stress clinic in Sydney, Australia, with follow-up through 6 months. Interventions: Both groups received once-weekly 90-minute individual sessions for 11 weeks. Grief-focused cognitive behavior therapy comprised 5 sessions of recalling memories of the deceased, plus cognitive restructuring and planning future social and positive activities. Mindfulness-based cognitive therapy comprised mindfulness exercises adapted to tolerate grief-related distress. Main Outcomes and Measures: The primary outcome was change in prolonged grief disorder severity measured by the PG-13 scale assessed at baseline, 1 week posttreatment, and 6 months after treatment (primary outcome time point), as well as secondary outcome measures of depression, anxiety, grief-related cognition, and quality of life. Results: The trial included 100 participants (mean [SD] age, 47.3 [13.4] years; 87 [87.0%] female), 50 in the grief-focused cognitive behavior therapy condition and 50 in the mindfulness-based cognitive therapy condition. Linear mixed models indicated that at the 6-month assessment, participants in the grief-focused cognitive behavior therapy group showed greater reduction in PG-13 scale score relative to those in the mindfulness-based cognitive therapy group (mean difference, 7.1; 95% CI, 1.6-12.5; P = .01), with a large between-group effect size (0.8; 95% CI, 0.2-1.3). Participants in the grief-focused cognitive behavior therapy group also demonstrated greater reductions in depression as measured on the Beck Depression Inventory than those in the mindfulness-based cognitive therapy group (mean difference, 6.6; 95% CI, 0.5-12.9; P = .04) and grief-related cognition (mean difference, 14.4; 95% CI, 2.8-25.9; P = .02). There were no other significant differences between treatment groups and no reported adverse events. Conclusions and Relevance: In this study, grief-focused cognitive behavior therapy conferred more benefit for core prolonged grief disorder symptoms and associated problems 6 months after treatment than mindfulness-based cognitive therapy. Although both treatments may be considered for prolonged grief disorder, grief-focused cognitive behavior therapy might be the more effective choice, taking all factors into consideration. Trial Registration: anzctr.org.au Identifier: ACTRN12612000307808.

A pilot study of the role of the BDNF Val66Met polymorphism in response to exercise-augmented exposure therapy for posttraumatic stress disorder.

Brain-Derived Neurotrophic Factor (BDNF) is implicated in extinction learning, which is a primary mechanism of exposure therapy for posttraumatic stress disorder (PTSD). Brief aerobic exercise has been shown to promote BDNF release and augment extinction learning. On the premise that the Val allele of the BDNF Val66Met polymorphism facilitates greater release of BDNF, this study examined the extent to which the Val allele of the BDNF polymorphism predicted treatment response in PTSD patients who underwent exposure therapy combined with aerobic exercise or passive stretching. PTSD patients (N = 85) provided saliva samples in order to extract genomic DNA to identify Val/Val and Met carriers of the BDNF Val66Met genotype, and were assessed for PTSD severity prior to and following a 9-week course of exposure therapy combined with aerobic exercise or stretching. The sample comprised 52 Val/Val carriers and 33 Met carriers. Patients with the BDNF high-expression Val allele display greater reduction of PTSD symptoms at posttreatment than Met carriers. Hierarchical regression analysis indicated that greater PTSD reduction was specifically observed in Val/Val carriers who received exposure therapy in combination with the aerobic exercise. This finding accords with animal and human evidence that the BDNF Val allele promotes greater extinction learning, and that these individuals may benefit more from exercise-augmented extinction. Although preliminary, this result represents a possible avenue for augmented exposure therapy in patients with the BDNF Val allele.

Habituation of distress during exposure and its relationship to treatment outcome in post-traumatic stress disorder and prolonged grief disorder.

Background: Reliving distressing memories is a core component of treatments for post-traumatic stress disorder (PTSD) and prolonged grief disorder (PGD). There is little understanding of how reliving these memories functions in the treatment of these disorders.Objective: This study investigated whether reliving functions comparably in the treatment of PTSD and PGD, and whether it is comparably related to treatment outcome.Method: This study conducted a reanalysis of patients with either PTSD (n = 55) or PGD (n = 45) who underwent treatments that comprised at least four sessions of reliving memories of either their traumatic experience or the loss of the deceased person.Results: PTSD participants displayed greater habituation of distress across sessions during reliving than PGD participants. Between-session reduction in distress during reliving was associated with symptom remission in PTSD, but this pattern was not observed in PGD.Conclusion: This pattern of findings indicates that although reliving appears to be a useful strategy for treating both PTSD and PGD, this strategy does not function comparably in the two conditions and may involve distinct mechanisms.

Reliving distressing memories is key to treatment of PTSD and prolonged grief disorder.Distress during memory reliving habituated in PTSD treatment more than in treatment of grief.Habituation of distress during treatment predicted remission of symptoms in PTSD but not grief.

Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial.

BACKGROUND: Although exposure therapy is central in most front-line psychotherapies of post-traumatic stress disorder (PTSD), many patients do not respond to this treatment. We aimed to investigate the effects of brief aerobic exercise on the efficacy of exposure therapy in reducing the severity of PTSD. METHODS: We did a single-blind, parallel, randomised controlled trial in Sydney, NSW, Australia. We included adults (aged ≥18 years) with clinician-diagnosed PTSD. We excluded participants aged 70 years or older, with imminent suicidal risk (reporting suicidal plan), presence of psychosis or substance dependence, history of moderate-to-severe traumatic brain injury, or presence of a physical disorder or impairment that might be exacerbated by aerobic exercise (eg, back pain). We randomly assigned participants (1:1) to nine 90-min weekly sessions of exposure therapy for PTSD with 10 min aerobic exercise or to the control group of exposure therapy with 10 min passive stretching. The primary outcome was PTSD severity measured by the clinician-administered PTSD scale 2 (CAPS-2), independently assessed at baseline, 1 week after treatment, and 6 months after treatment (primary outcome timepoint). FINDINGS: Between Dec 12, 2012, and July 25, 2018, we enrolled 130 participants with PTSD, with 65 (50%) participants randomly assigned to exposure therapy with exercise and 65 (50%) to exposure therapy with passive stretching, including 79 (61%) women and 51 (39%) men, with a mean age of 39·1 years (SD 14·4; range 18-69). 99 (76%) participants were White, 14 (11%) were Asian, and 17 (13%) were listed as other. At the 6-month follow-up assessment, participants in the exposure therapy with exercise group showed greater reductions in CAPS-2 scores relative to those in the exposure therapy with stretching group (mean difference 12·1 [95% CI 2·4-21·8]; p=0·023), which resulted in a moderate effect size of 0·6 (0·1-1·1). No adverse events associated with the intervention were reported. The trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry, ACTRN12612000185864. INTERPRETATION: Brief aerobic exercise has the potential to augment long-term gains of exposure therapy for PTSD, which accords with evidence from studies in animals and humans on the role of exercise in modulating the extinction learning processes. This strategy might offer a simple and affordable means to augment treatment gains for exposure therapy in people with PTSD. FUNDING: Australian National Health and Medical Research Council.

Treating Prolonged Grief Disorder: A 2-Year Follow-Up of a Randomized Controlled Trial.

BACKGROUND: Prolonged grief disorder (PGD) causes significant impairment in approximately 7% of bereaved people. Although cognitive-behavioral therapy (CBT) has been shown to effectively treat PGD, there is no evidence of long-term effects of CBT. OBJECTIVE: To determine the long-term efficacies of CBT with exposure or CBT without exposure in treating PGD by assessing outcome at 2 years. METHODS: A randomized controlled trial of PGD patients (N = 80) attending an outpatient clinic took place between September 2007 and June 2010, and a 2-year follow-up occurred between December 2009 and October 2012. All patients received 10 weekly 2-hour group therapy sessions that comprised CBT techniques. Patients also received 4 individual sessions in which they were randomly allocated to receive exposure therapy (CBT/Exposure) for memories of the death or supportive counseling (CBT). Prolonged grief disorder was assessed by clinical interview using the Complicated Grief Assessment. Severity of PGD, the primary outcome, was assessed using the Inventory of Complicated Grief. RESULTS: Intent-to-treat analyses indicated a significant linear time × treatment condition interaction effect at 2 years (B = -0.63; SE = 0.26; t225 = -2.44; P = .02; 95% CI, -1.14 to -0.12), indicating that CBT/Exposure led to greater reductions in PGD than CBT. Further, the linear between-group effect size at the 2-year follow-up was 1.15. CONCLUSIONS: Exposure therapy in the course of CBT leads to greater reduction in symptoms of PGD than CBT without exposure, and this additive gain extends 2 years after treatment is complete. To achieve optimal treatment gains in patients with PGD, therapists should encourage some form of exposure therapy to memories of the death. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry identifier: ACTRN12609000229279.

Predictors of treatment response for cognitive behaviour therapy for prolonged grief disorder.

Background: Prolonged grief disorder (PGD) causes significant impairment in approximately 7% of bereaved people. Although cognitive behaviour therapy (CBT) has been shown to effectively treat PGD, there is a need to identify predictors of treatment non-response. Methods: PGD patients (N = 80) were randomly allocated to receive 10 weekly two-hour group CBT sessions and (a) four individual sessions of exposure therapy or (b) CBT without exposure. PGD was assessed by self-report measures at baseline, post-treatment (N = 61), and six-months (N = 56) after treatment. Results: Post-treatment assessments indicated that greater reduction in grief severity relative to pretreatment levels was associated with being in the CBT/Exposure condition, and lower baseline levels of self-blame and avoidance. At follow-up, greater grief symptom reduction was associated with being in the CBT/Exposure condition and lower levels of avoidance. Conclusions: These patterns suggest that strategies that target excessive self-blame and avoidance during treatment may enhance response to grief-focused cognitive behaviour therapy.

Antecedentes: El trastorno por duelo prolongado (PGD, por sus siglas en inglés) causa un deterioro significativo en aproximadamente el 7% de las personas en duelo. Aunque se ha demostrado que la terapia cognitivo conductual (TCC) es efectiva para tratar el PGD, existe una necesidad de identificar factores predictivos de la falta de respuesta al tratamiento. Método: Los pacientes con PGD (N = 80) fueron asignados al azar para recibir 10 sesiones semanales de TCC grupales de 2 horas y (a) 4 sesiones individuales de terapia de exposición o (b) TCC sin exposición. El PGD se evaluó mediante medidas de auto-reporte en línea base, post-tratamiento (N = 61) y 6 meses después del tratamiento (N = 56). Resultados: Las evaluaciones post-tratamiento indicaron que una mayor reducción en la gravedad del duelo en relación con los niveles pre-tratamiento se asoció con estar en la condición de TCC con exposición y con niveles basales más bajos de culpa a sí mismo y evitación. En el seguimiento, una mayor reducción de los síntomas de duelo se asoció con estar en la condición de TCC con exposición y con menores niveles de evitación. Conclusiones: Estos patrones sugieren que estrategias dirigidas a la excesiva culpa a sí mismo y a la evitación durante el tratamiento pueden mejorar la respuesta a la terapia cognitivo conductual centrada en el duelo.

Treating prolonged grief disorder: a randomized clinical trial.

IMPORTANCE: Prolonged grief disorder (PGD) is a potentially disabling condition that affects approximately 10% of bereaved people. Grief-focused cognitive behavior therapy (CBT) has been shown to be effective in treating PGD. Although treatments for PGD have focused on exposure therapy, much debate remains about whether exposure therapy is optimal for PGD. OBJECTIVE: To determine the relative efficacies of CBT with exposure therapy (CBT/exposure) or CBT alone for PGD. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 80 patients with PGD attending the outpatient University of New South Wales Traumatic Stress Clinic from September 17, 2007, through June 7, 2010. INTERVENTIONS: All patients received 10 weekly 2-hour group therapy sessions that consisted of CBT techniques. Patients also received 4 individual sessions, in which they were randomized to receive exposure therapy for memories of the death or supportive counseling. MAIN OUTCOMES AND MEASURES: Measures of PGD by clinical interview and self-reported measures of depression, cognitive appraisals, and functioning at the 6-month follow-up. RESULTS: Intention-to-treat analyses at follow-up indicated a significant quadratic time×treatment condition interaction effect (B [SE], 0.49 [0.16]; t120.16=3.08 [95% CI, 0.18-0.81]; P=.003), indicating that CBT/exposure led to greater PGD reductions than CBT alone. At follow-up, CBT/exposure led to greater reductions in depression (B [SE], 0.35 [0.12]; t112.65=2.83 [95% CI, 0.11-0.60]; P=.005), negative appraisals (B [SE], 0.68 [0.25]; t109.98=2.66 [95% CI, 0.17-1.18]; P=.009), and functional impairment (B [SE], 0.24 [0.08]; t111.40=3.01 [95% CI, 0.08-0.40]; P=.003) than CBT alone. In terms of treatment completers, fewer patients in the CBT/exposure condition at follow-up (14.8%) met criteria for PGD than those in the CBT condition (37.9%) (odds ratio, 3.51; 95% CI, 0.96-12.89; χ2=3.81; P=.04). CONCLUSIONS AND RELEVANCE: Including exposure therapy that promotes emotional processing of memories of the death is an important component to achieve optimal reductions in PGD severity. Facilitating emotional responses to the death may promote greater changes in appraisals about the loss, which are associated with symptom reduction. Promotion of emotional processing techniques in therapies to treat patients with PGD is needed. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12609000229279.