Effects on voice hearing distress and social functioning of unguided application of a smartphone app - A randomized controlled trial.

Background: Temstem is a smartphone app developed with and for clinical voice hearing individuals with the aim to reduce their voice hearing distress and improve social functioning. Methods: A randomized controlled trial with adult outpatients suffering from distressing and frequent auditory verbal hallucinations (AVH) was conducted. Participants were randomized to unguided 'Temstem+AVH monitoring' or unguided 'AVH monitoring only' (control condition). Assessments were performed at baseline, post-intervention (week 5-6), and follow-up (week 9-10). Primary outcomes were voice hearing distress and social functioning, as measured with Experience Sampling Method (ESM), consisting of multiple daily questionnaires during six days. In addition, voices and mood were self-monitored with help of a daily reflective questionnaire. Analyses were linear regression models (intention-to-treat). Results: 44 Participants were allocated to Temstem and 45 to the control condition. No significant differences between the groups were found on both primary outcomes. Conclusion: Our results do not support the effectiveness of stand-alone use of Temstem versus symptom monitoring on voice hearing distress or social functioning in voice hearing individuals. In order to potentially improve effectiveness of an mHealth tool in a population of people with frequent and distressing voices, we recommend to involve persons with lived experience in all stages of development and research; to thoroughly test the (technological) usability before performing an RCT; to test whether guidance of a therapist is needed to optimize effectiveness; and to provide prompts to remind the user to actually use the tool.

The bumpy road of trauma-focused treatment: Posttraumatic stress disorder symptom exacerbation in people with psychosis.

Concern for symptom exacerbation and treatment drop-out is an important barrier to the implementation of trauma-focused therapy (TFT), especially in people with a psychotic disorder. This study, which was part of a multicenter randomized controlled trial, investigated posttraumatic stress disorder (PTSD) symptom exacerbation during eye movement desensitization reprocessing (EMDR) therapy and prolonged exposure (PE) in a sample of 99 participants with PTSD and psychosis. Symptom exacerbations during the first four sessions (early exacerbation) and between-session exacerbations over the course of therapy were monitored using the PTSD Symptom Scale-Self Report. Analyses of covariance and chi-square tests were conducted to investigate exacerbation rates and their associations with treatment response and drop-out. Both early exacerbation and between-session exacerbation were relatively common (32.3% and 46.5%, respectively) but were unrelated to poor treatment response or an increased likelihood of treatment drop-out. Both clinicians and patients need to be aware that symptom exacerbation during TFT is common and not related to poor outcomes. Symptom exacerbation can be part of the therapeutic process, should be acknowledged and guided, and should not be a barrier to the implementation of TFT in people with psychosis.

Trauma-focused therapies for post-traumatic stress in psychosis: study protocol for the RE.PROCESS randomized controlled trial.

INTRODUCTION: Many people with psychotic disorders experience symptoms of post-traumatic stress disorder (PTSD). In recent years, several trauma-focused therapies (TFTs), including cognitive restructuring (CR), prolonged exposure (PE), and eye movement desensitization and reprocessing (EMDR) have been studied and found to be safe and effective in reducing PTSD symptoms in individuals with psychosis. However, studies were conducted in different countries, with varying inclusion criteria, therapy duration, control groups, and trial outcomes. RE.PROCESS will be the first study to compare the impact of CR, PE, and EMDR with a waiting list control condition within the same context. METHODS AND ANALYSIS: This is the protocol of a pragmatic, single-blind, multicentre, superiority randomized controlled trial, in which CR, PE, and EMDR are compared to a waiting list control condition for TFT (WL) in a naturalistic treatment setting. Inclusion criteria are as follows: age ≥ 16 years; meeting full DSM-5 diagnostic criteria for PTSD on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a total CAPS score ≥ 23; and a psychotic disorder in the schizophrenia spectrum confirmed by the Structured Clinical Interview for DSM-5 (SCID-5). Participants (N=200) will be randomly allocated to 16 sessions of one of the TFTs or WL, in addition to receiving treatment as usual (TAU) for psychosis. The primary objective is to compare the effects of CR, PE, and EMDR to WL on researcher-rated severity of PTSD symptoms over time from baseline to 6-month follow-up. Secondary objectives are to examine these effects at the separate time-points (i.e., mid-treatment, post-treatment, and at 6-month follow-up) and to test the effects for clinician-rated presence of PTSD diagnosis, and self-rated severity of (complex) PTSD symptoms. DISCUSSION: This is the first RCT to directly compare the effects of CR, PE, and EMDR within the same context to TAU on PTSD symptoms in individuals with psychosis and PTSD. Secondary effects on clinical and functional outcomes will be investigated both directly after therapy and long term. TRIAL REGISTRATION: ISRCTN ISRCTN56150327 . Registered 18 June 2019.

Health-economic benefits of treating trauma in psychosis.

Background: Co-occurrence of posttraumatic stress disorder (PTSD) in psychosis (estimated as 12%) raises personal suffering and societal costs. Health-economic studies on PTSD treatments in patients with a diagnosis of a psychotic disorder have not yet been conducted, but are needed for guideline development and implementation. This study aims to analyse the cost-effectiveness of guideline PTSD therapies in patients with a psychotic disorder. Methods: This health-economic evaluation alongside a randomized controlled trial included 155 patients with a psychotic disorder in care as usual (CAU), with comorbid PTSD. Participants received eye movement desensitization and reprocessing (EMDR) (n = 55), prolonged exposure (PE) (n = 53) or waiting list (WL) (n = 47) with masked assessments at baseline (T0) and at the two-month (post-treatment, T2) and six-month follow-up (T6). Costs were calculated using the TiC-P interview for assessing healthcare consumption and productivity losses. Incremental cost-effectiveness ratios and economic acceptability were calculated for quality-adjusted life years (EQ-5D-3L-based QALYs) and PTSD 'Loss of diagnosis' (LoD, CAPS). Results: Compared to WL, costs were lower in EMDR (-€1410) and PE (-€501) per patient per six months. In addition, EMDR (robust SE 0.024, t = 2.14, p = .035) and PE (robust SE 0.024, t = 2.14, p = .035) yielded a 0.052 and 0.051 incremental QALY gain, respectively, as well as 26% greater probability for LoD following EMDR (robust SE = 0.096, z = 2.66, p = .008) and 22% following PE (robust SE 0.098, z = 2.28, p = .023). Acceptability curves indicate high probabilities of PTSD treatments being the better economic choice. Sensitivity analyses corroborated these outcomes. Conclusion: Adding PTSD treatment to CAU for individuals with psychosis and PTSD seem to yield better health and less PTSD at lower costs, which argues for implementation.

Antecedentes: La comorbilidad de TEPT en la psicosis (estimada en 12%) aumenta el sufrimiento personal y los costos para la sociedad. No se han realizado aún estudios de economía de la salud de los tratamientos de TEPT en pacientes con diagnóstico de un trastorno psicótico, pero son necesarios para el desarrollo e implementación de guías. Este estudio apunta a analizar la costo-efectividad de las terapias para TEPT con guías clínicas en pacientes con un trastorno psicótico.Métodos: Esta evaluación de economía de la salud asociada a un estudio randomizado controlado incluyó a 155 pacientes con un trastorno psicótico en cuidado habitual (CAU), con TEPT comórbido.Los pacientes recibieron terapia de reprocesamiento por movimientos oculares (EMDR, n=55), exposición prolongada (PE, n=53) o lista de espera (WL, n=47) con evaluaciones ciegas basal (T0), a los 2 meses (post-tratamiento, T2) y a los 6 meses de seguimiento (T6). Los costos fueron calculados usando la entrevista TiC-P para evaluar el consumo en los sistemas de salud y pérdidas de productividad. Las tasas incrementales de costo-efectividad y acepabilidad económica fueron calculadas por Años de Vida ajustados por calidad (QALY basado en EQ-5D-3L) y pérdida de diagnóstico de TEPT (LoD, CAPS)Resultados: En comparación a lista de espera, los costos fueron menores en EMDR (-€1410) y PE (-€501) por paciente por cada 6 meses. Además, EMDR (SE robusta 0.024, t=2.14, p=0.035) y PE (SE robusta 0.024, t=2.14, p=0.035) produjeron una ganancia incremental en QALY de 0.05 y una probabilidad 26% mayor de LoD luego de EMDR (SE robusta 0.096, z=2.66, p=0.008) y 22% luego de PE (SE robusta 0.098, z=2.28, p=0.023). Las curvas de aceptabilidad indican altas probabilidades de que los tratamientos para TEPT sean la mejor alternativa económica. Los análisis de sensibilidad corroboraron estos resultados.Conclusion: El agregar tratamiento para TEPT a los cuidados habituales en pacientes con psicosis y TEPT parece producir mejor salud y menos TEPT a menor costo, lo que aboga por su implementación.

Long-term outcomes of trauma-focused treatment in psychosis.

We present 12-month follow-up results for a randomised controlled trial of prolonged exposure and eye movement desensitisation and reprocessing (EMDR) therapy in 85 (78.8%) participants with psychotic disorder and comorbid post-traumatic stress disorder (PTSD). Positive effects on clinician-rated PTSD, self-rated PTSD, depression, paranoid-referential thinking and remission from schizophrenia were maintained up to 12-month follow-up. Negative post-traumatic cognitions declined in prolonged exposure and were stable in EMDR. A significant decline in social functioning was found, whereas reductions in interference of PTSD symptoms with social functioning were maintained. These results support that current PTSD guidelines apply to individuals with psychosis. Declaration of interest M.v.d.G. and D.v.d.B. receive income for published books on psychotic disorders and for the training of postdoctoral professionals in the treatment of psychotic disorders. A.d.J. receives income for published books on EMDR therapy and for the training of postdoctoral professionals in this method. A.v.M. receives income for published book chapters on PTSD and for the training of postdoctoral professionals in prolonged exposure. C.d.R. receives income for the training of postdoctoral professionals in EMDR therapy.

Exposing therapists to trauma-focused treatment in psychosis: effects on credibility, expected burden, and harm expectancies.

BACKGROUND: Despite robust empirical support for the efficacy of trauma-focused treatments, the dissemination proves difficult, especially in relation to patients with comorbid psychosis. Many therapists endorse negative beliefs about the credibility, burden, and harm of such treatment. OBJECTIVE: This feasibility study explores the impact of specialized training on therapists' beliefs about trauma-focused treatment within a randomized controlled trial. METHOD: Therapist-rated (n=16) credibility, expected burden, and harm expectancies of trauma-focused treatment were assessed at baseline, post-theoretical training, post-technical training, post-supervised practical training, and at 2-year follow-up. Credibility and burden beliefs of therapists concerning the treatment of every specific patient in the trial were also assessed. RESULTS: Over time, therapist-rated credibility of trauma-focused treatment showed a significant increase, whereas therapists' expected burden and harm expectancies decreased significantly. In treating posttraumatic stress disorder (PTSD) in patients with psychotic disorders (n=79), pre-treatment symptom severity was not associated with therapist-rated credibility or expected burden of that specific treatment. Treatment outcome had no influence on patient-specific credibility or burden expectancies of therapists. CONCLUSIONS: These findings support the notion that specialized training, including practical training with supervision, has long-term positive effects on therapists' credibility, burden, and harm beliefs concerning trauma-focused treatment.

Predicting trauma-focused treatment outcome in psychosis.

OBJECTIVE: Although TF treatments are effective in patients with psychosis, it is unknown whether specific psychosis-related obstacles limit the effects, and what determines good outcome. METHODS: Baseline posttraumatic stress disorder (PTSD) symptom severity and seven psychosis-specific variables were tested as predictors in patients with a psychotic disorder and PTSD (n=108), who received eight sessions of TF treatment (Prolonged Exposure, or Eye Movement Desensitization and Reprocessing therapy) in a single-blind randomized controlled trial. Multiple regression analyses were performed. RESULTS: Baseline PTSD symptom severity was significantly associated with posttreatment PTSD symptom severity, explaining 11.4% of the variance. Additionally, more severe PTSD at baseline was also significantly associated with greater PTSD symptom improvement during treatment. After correction for baseline PTSD symptom severity, the model with the seven baseline variables did not significantly explain the variance in posttreatment PTSD outcome. Within this non-significant model, the presence of auditory verbal hallucinations contributed uniquely to posttreatment outcome but explained little variance (5.4%). Treatment completers and dropouts showed no significant difference on any of the psychosis-related variables. CONCLUSIONS: Given the low predictive utility of baseline psychosis-related factors, we conclude that there is no evidence-based reason to exclude patients with psychotic disorders from TF treatments. Also, we speculate that patients with psychosis and severe baseline PTSD might derive more benefit if given more than eight sessions. Trial registration current controlled-trials.com | Identifier: ISRCTN79584912 | http://www.isrctn.com/ISRCTN79584912.

Trauma-Focused Treatment in PTSD Patients With Psychosis: Symptom Exacerbation, Adverse Events, and Revictimization.

OBJECTIVES: Most clinicians refrain from trauma treatment for patients with psychosis because they fear symptom exacerbation and relapse. This study examined the negative side effects of trauma-focused (TF) treatment in patients with psychosis and posttraumatic stress disorder (PTSD). METHODS: Analyses were conducted on data from a single-blind randomized controlled trial comparing TF treatment (N = 108; 8 sessions prolonged exposure or eye movement desensitization) and waiting list (WL; N = 47) among patients with a lifetime psychotic disorder and current chronic PTSD. Symptom exacerbation, adverse events, and revictimization were assessed posttreatment and at 6-month follow-up. Also investigated were symptom exacerbation after initiation of TF treatment and the relationship between symptom exacerbation and dropout. RESULTS: Any symptom exacerbation (PTSD, paranoia, or depression) tended to occur more frequently in the WL condition. After the first TF treatment session, PTSD symptom exacerbation was uncommon. There was no increase of hallucinations, dissociation, or suicidality during the first 2 sessions. Paranoia decreased significantly during this period. Dropout was not associated with symptom exacerbation. Compared with the WL condition, fewer persons in the TF treatment condition reported an adverse event (OR = 0.48, P = .032). Surprisingly, participants receiving TF treatment were significantly less likely to be revictimized (OR = 0.40, P = .035). CONCLUSIONS: In these participants, TF treatment did not result in symptom exacerbation or adverse events. Moreover, TF treatment was associated with significantly less exacerbation, less adverse events, and reduced revictimization compared with the WL condition. This suggests that conventional TF treatment protocols can be safely used in patients with psychosis without negative side effects.

Predictive validity of the Trauma Screening Questionnaire in detecting post-traumatic stress disorder in patients with psychotic disorders.

BACKGROUND: Post-traumatic stress disorder (PTSD) is highly prevalent in patients with a psychotic disorder. Because a PTSD diagnosis is often missed in patients with psychosis in routine care, a valid screening instrument could be helpful. AIMS: To determine the validity of the Trauma Screening Questionnaire (TSQ) as a screening tool for PTSD among individuals with psychotic disorders. METHOD: Among 2608 patients with a psychotic disorder, the rate of trauma exposure was determined and the TSQ was administered to screen for PTSD. PTSD status was verified in 455 patients using the Clinician-Administered PTSD Scale (trial registration: ISRCTN 79584912). RESULTS: Trauma exposure was reported by 78.2% of the 2608 patients. PTSD prevalence was estimated at 16% (95% CI 14.6-17.4%) compared with 0.5% reported in the patients' clinical charts. A TSQ cut-off score of six predicted PTSD with 78.8% sensitivity, 75.6% specificity, 44.5% correct positives and 93.6% correct negatives. CONCLUSIONS: The TSQ seems to be a valid screening tool for PTSD in patients with a psychotic disorder.

Prolonged exposure vs eye movement desensitization and reprocessing vs waiting list for posttraumatic stress disorder in patients with a psychotic disorder: a randomized clinical trial.

IMPORTANCE: The efficacy of posttraumatic stress disorder (PTSD) treatments in psychosis has not been examined in a randomized clinical trial to our knowledge. Psychosis is an exclusion criterion in most PTSD trials. OBJECTIVE: To examine the efficacy and safety of prolonged exposure (PE) therapy and eye movement desensitization and reprocessing (EMDR) therapy in patients with psychotic disorders and comorbid PTSD. DESIGN, SETTING, AND PARTICIPANTS: A single-blind randomized clinical trial with 3 arms (N = 155), including PE therapy, EMDR therapy, and waiting list (WL) of 13 outpatient mental health services among patients with a lifetime psychotic disorder and current chronic PTSD. Baseline, posttreatment, and 6-month follow-up assessments were made. INTERVENTIONS: Participants were randomized to receive 8 weekly 90-minute sessions of PE (n = 53), EMDR (n = 55), or WL (n = 47). Standard protocols were used, and treatment was not preceded by stabilizing psychotherapeutic interventions. MAIN OUTCOMES AND MEASURES: Clinician-rated severity of PTSD symptoms, PTSD diagnosis, and full remission (on the Clinician-Administered PTSD Scale) were primary outcomes. Self-reported PTSD symptoms and posttraumatic cognitions were secondary outcomes. RESULTS: Data were analyzed as intent to treat with linear mixed models and generalized estimating equations. Participants in the PE and EMDR conditions showed a greater reduction of PTSD symptoms than those in the WL condition. Between-group effect sizes were 0.78 (P < .001) in PE and 0.65 (P = .001) in EMDR. Participants in the PE condition (56.6%; odds ratio [OR], 3.41; P = .006) or the EMDR condition (60.0%; OR, 3.92; P < .001) were significantly more likely to achieve loss of diagnosis during treatment than those in the WL condition (27.7%). Participants in the PE condition (28.3%; OR, 5.79; P = .01), but not those in the EMDR condition (16.4%; OR, 2.87; P = .10), were more likely to gain full remission than those in the WL condition (6.4%). Treatment effects were maintained at the 6-month follow-up in PE and EMDR. Similar results were obtained regarding secondary outcomes. There were no differences in severe adverse events between conditions (2 in PE, 1 in EMDR, and 4 in WL). The PE therapy and EMDR therapy showed no difference in any of the outcomes and no difference in participant dropout (24.5% in PE and 20.0% in EMDR, P = .57). CONCLUSIONS AND RELEVANCE: Standard PE and EMDR protocols are effective, safe, and feasible in patients with PTSD and severe psychotic disorders, including current symptoms. A priori exclusion of individuals with psychosis from evidence-based PTSD treatments may not be justifiable. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN79584912.

A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis.

BACKGROUND: Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study's primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. METHODS/DESIGN: A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, two months post treatment, and six months post treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. DISCUSSION: The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change. TRIAL REGISTRATION: Trial registration: ISRCTN79584912.

Trauma, psychosis, post-traumatic stress disorder and the application of EMDR.

In this article we describe three interactions between trauma, post-traumatic stress disorder (PTSD) and psychosis: 1. many patients with psychotic disorders suffered from traumatic life experiences that play an important role in the onset and content of their psychosis; 2. the experience of psychosis as well as its psychiatric treatment may result in post-traumatic stress symptoms; 3. if psychosis and PTSD occur simultaneously, there is a substantial risk for reciprocal negative reinforcement of both symptom groups as well as for potentially on going traumatization. Although these interactions are highly relevant from a clinical perspective, they usually remain unattended in routine care. The three interactions will be illustrated by a case history as well as an impression of the psychological treatment including EMDR. We recommend to pay attention to traumatization and comorbid PTSD in routine care for people with psychosis, as well as to offer them treatment.