ABSTRACT
BACKGROUND: Delivery of preventative interventions via mobile phone apps offers an effective and accessible way to address the global priority of improving the mental health of adolescents and young adults. A proven risk factor for anxiety and depression is elevated worry and rumination, also known as repetitive negative thinking (RNT). OBJECTIVE: This was a prevention mechanism trial that aimed to investigate whether an RNT-targeting self-help mobile phone app (MyMoodCoach) reduces worry and rumination in young adults residing in the United Kingdom. A secondary objective was to test whether the app reduces symptoms of anxiety and depression and improves well-being. METHODS: A web-based, single-blind, 2-arm parallel-group randomized controlled trial was conducted with 236 people aged between 16 and 24 years, who self-reported high levels of worry or rumination. Eligible participants were randomized to an active intervention group (usual practice, plus up to 6 weeks of using the RNT-targeting mobile app, n=119) or a waitlist control group (usual practice with no access to the app until after 6 weeks, n=117). The primary outcome was changes in worry and rumination 6 weeks after randomization. Secondary outcomes included changes in well-being and symptoms of anxiety and depression after 6 weeks and changes in all measures after 12 weeks. RESULTS: Participants randomly allocated to use the RNT-targeting self-help app showed significantly lower levels of rumination (mean difference -2.92, 95% CI -5.57 to -0.28; P=.03; ηp2=0.02) and worry (mean difference -3.97, 95% CI -6.21 to -1.73; P<.001; ηp2=0.06) at 6-week follow-up, relative to the waitlist control. Similar differences were observed for well-being (P<.001), anxiety (P=.03), and depression (P=.04). The waitlist control group also showed improvement when given access to the app after 6 weeks. Improvements observed in the intervention group after 6 weeks of using the app were maintained at the 12-week follow-up point. CONCLUSIONS: The MyMoodCoach app had a significant positive effect on worry and rumination, well-being, anxiety, and depression in young adults, relative to waitlist controls, providing proof-of-principle that an unguided self-help app can effectively reduce RNT. This app, therefore, has potential for the prevention of anxiety and depression although longer-term effects on incidence need to be directly evaluated. TRIAL REGISTRATION: ClinicalTrials.gov NCT04950257; https://www.clinicaltrials.gov/ct2/show/NCT04950257. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-021-03536-0.
Subject(s)
Anxiety , Mobile Applications , Rumination, Cognitive , Humans , Male , Mobile Applications/statistics & numerical data , Mobile Applications/standards , Female , Adolescent , Single-Blind Method , Young Adult , United Kingdom , Rumination, Cognitive/physiology , Anxiety/psychology , Anxiety/therapy , Depression/psychology , Depression/therapyABSTRACT
PROTOCOL REGISTRATION: PROSPERO (CRD42023408899).
ABSTRACT
Background: Sudden gains, defined as large and stable improvements of psychopathological symptoms, are a ubiquitous phenomenon in psychotherapy. They have been shown to occur across several clinical contexts and to be associated with better short-term and long-term treatment outcome. However, the approach of sudden gains has been criticized for its tautological character: sudden gains are included in the computation of treatment outcomes, ultimately resulting in a circular conclusion. Furthermore, some authors criticize sudden gains as merely being random fluctuations.Objective: Use of efficient methods to evaluate whether the amount of sudden gains in a given sample lies above chance level.Method: We used permutation tests in a sample of 85 patients with posttraumatic stress disorder (PTSD) treated with trauma-focused cognitive behaviour therapy in routine clinical care. Scores of self-reported PTSD symptom severity were permuted 10.000 times within sessions and between participants to receive a random distribution.Results: Altogether, 18 participants showed a total of 24 sudden gains within the first 20 sessions. The permutation test yielded that the frequency of sudden gains was not beyond chance level. No significant predictors of sudden gains were identified and sudden gains in general were not predictive of treatment outcome. However, subjects with early sudden gains had a significantly lower symptom severity after treatment.Conclusions: Our data suggest that a significant proportion of sudden gains are due to chance. Further research is needed on the differential effects of early and late sudden gains.
Treatment-related sudden gains exhibit clinical significance when their manifestation is above chance level.We used permutation tests to examine their occurrence in trauma-focused cognitive behaviour therapy as applied in a naturalistic treatment setting.The occurrence of sudden gains in general was not significantly higher than chance, yet early sudden gains were associated with improved treatment outcome.
Subject(s)
Cognitive Behavioral Therapy , Stress Disorders, Post-Traumatic , Humans , Cognitive Behavioral Therapy/methods , Treatment Outcome , Psychotherapy , Stress Disorders, Post-Traumatic/diagnosis , Stress Disorders, Post-Traumatic/therapy , Stress Disorders, Post-Traumatic/psychology , Self ReportABSTRACT
Prior research suggests that repetitive negative thinking (RNT) negatively impacts mental health by intensifying and prolonging emotional reactivity to stress. This study investigated whether an intervention designed to reduce RNT alters emotional reactivity. Young adults with high trait RNT (N = 79) were randomly allocated to an RNT-focused intervention (smartphone app-based, 10 days) or a waiting list before exposure to a standardized stressor. The pre-registered analysis did not reveal a significant condition * time interaction for negative affect. However, exploratory analyses showed that whilst initial increases in negative affect in response to the stressor did not differ between conditions, participants in the intervention condition reported less negative affect throughout the following recovery phase. Additionally, participants in the intervention condition appraised their ability to cope with the stressor as higher and reported less RNT in the recovery phase. In contrast, the intervention did not affect biological stress responses. The findings indicate that RNT-focused interventions might have positive effects on mental health by breaking the self-reinforcing cycle of RNT, negative affect and maladaptive appraisals in response to stress. However, as findings are partly based on exploratory analyses, further research is needed to confirm whether reduced subjective stress reactivity mediates the effects of RNT-focused interventions on psychopathological symptoms.
Subject(s)
Stress, Psychological , Humans , Male , Female , Stress, Psychological/psychology , Stress, Psychological/therapy , Young Adult , Adult , Adaptation, Psychological , Adolescent , Mobile Applications , Pessimism/psychology , Rumination, Cognitive/physiology , ThinkingABSTRACT
BACKGROUND: Globally, mental health conditions pose a substantial burden of disease. Despite the availability of evidence-based pharmacological and psychological treatments, the symptoms of a substantial subgroup of patients do not respond to these interventions, and only a minority of patients have access to them. This study aimed to assess the efficacy of ImPuls, a 6-month transdiagnostic group exercise intervention, plus treatment-as-usual, compared with treatment-as-usual alone in outpatients with various mental disorders. METHODS: In this pragmatic, two-arm, multisite, randomised controlled trial in Germany, ten outpatient rehabilitative and medical care facilities were involved as study sites. Participants were outpatients diagnosed according to ICD-10 with one or more of the following disorders based on structured clinical interviews: moderate or severe depression, primary insomnia, post-traumatic stress disorder (PTSD), panic disorder, or agoraphobia. Participants were required to be aged between 18 years and 65 years, insured by the health insurers Allgemeine Ortskrankenkasse Baden-Württemberg or Techniker Krankenkasse, fluent in German, and without medical contraindications for exercise. Blocks of six participants were randomly allocated to ImPuls plus treatment-as-usual or treatment-as-usual alone (allocation ratio: 1:1), stratified by study site. The randomisation sequence was generated by an external data manager. The team responsible for data collection and management was masked to the randomisation sequence. The ImPuls intervention comprised evidence-based outdoor exercises lasting 30 min, and aimed at achieving at least moderate intensity. It also incorporated behavioural change techniques targeting motivational and volitional determinants of exercise behaviour. Treatment-as-usual was representative of typical outpatient health care in Germany, allowing patients access to any standard treatments. The primary outcome was global symptom severity at 6 months after randomisation, measured using self-report on the Brief Symptom Inventory (BSI-18) and analysed in the intention-to-treat sample. No individuals with lived experience of mental illness were involved in conducting the study or writing the final publication. Safety was assessed in all participants. The trial was registered with the German Clinical Trials Register (DRKS00024152) with a completion date of June 30, 2024. FINDINGS: 600 patients provided informed consent, were recruited to the study, and underwent a diagnostic interview between Jan 1, 2021, and May 31, 2022. Following this, 199 were excluded on the basis of inclusion and exclusion criteria and one withdrew consent during the baseline assessment. Of the 400 eligible participants, 284 (71%) self-identified as female, 106 (27%) self-identified as male, and nine (2%) self-identified as other. The mean age was 42·20 years (SD 13·23; range 19-65). Ethnicity data were not assessed. 287 (72%) participants met the criteria for moderate or severe depression, 81 (20%) for primary insomnia, 37 (9%) for agoraphobia, 46 (12%) for panic disorder, and 72 (18%) for PTSD. 199 participants were allocated to the intervention group of ImPuls plus treatment-as-usual and 201 to the control group of treatment-as-usual alone. 38 (19%) participants did not receive the minimum ImPuls intervention dose. ImPuls plus treatment-as-usual demonstrated superior efficacy to treatment-as-usual alone in reducing global symptom severity, with an adjusted difference on BSI-18 of 4·11 (95% CI 1·74-6·48; d=0·35 [95% CI 0·14-0·56]; p=0·0007) at 6 months. There were no significant differences in the total number of adverse events or serious adverse events between the two groups. There was one serious adverse event (male, torn ligament) related to the intervention. INTERPRETATION: ImPuls is an efficacious transdiagnostic adjunctive treatment in outpatient mental health care. Our findings suggest that exercise therapy should be implemented in outpatient mental health care as an adjunctive transdiagnostic treatment for mental disorders such as depression, insomnia, panic disorder, agoraphobia, and PTSD. Transdiagnostic group exercise interventions might ameliorate the existing disparity in care provision between the many individuals in need of evidence-based treatment and the few who are receiving it. FUNDING: The German Innovation Fund of the Federal Joint Committee of Germany.
Subject(s)
Exercise Therapy , Mental Disorders , Adult , Aged , Female , Humans , Male , Middle Aged , Ambulatory Care/methods , Exercise Therapy/methods , Germany , Mental Disorders/therapy , Outpatients/statistics & numerical data , Psychotherapy, Group/methods , Treatment OutcomeABSTRACT
Background and objective: The current study aimed to investigate the within-day symptom dynamics in PTSD patients, specifically focusing on symptoms that most predict changes in other symptoms. The study included a baseline diagnostic assessment, followed by an assessment using the experience sampling method (ESM) via a smartphone.Method: Participants answered questions related to their PTSD symptoms four times per day for 15 consecutive days (compliance rate 75%). The clinical sample consisted of 48 treatment-seeking individuals: 44 with PTSD as a primary diagnosis, and four patients with subsyndromal PTSD, all of whom had not yet begun trauma-focused treatment. The ESM assessment included the 20 items from the PTSD Checklist for DSM-5, five items from the International Trauma Questionnaire (ITQ) assessing disturbances in relationships and functional impairment, and two items from the Clinician-Administered PTSD Scale for DSM-5 assessing symptoms of depersonalization and derealization.Results: Temporal networks (prospective associations between symptoms) showed that changes in hypervigilance predicted changes in the greatest number of symptoms at the next time point. Furthermore, hypervigilance showed temporal connections with at least one additional symptom from each of the DSM-5 PTSD symptom clusters.Conclusions: Results show that the contemporaneous network (representing the relationship between given symptoms within the same assessment occasion) and the temporal network (representing prospective associations between symptoms) differ and that it is important to estimate both. Some findings from earlier research are replicated, but heterogeneity across studies remains. Future studies should include potential moderators.
We investigated within-day symptom dynamics in PTSD patients using experience sampling technology.Temporal and contemporaneous symptom networks differed; thus, it is important to estimate both.Changes in hypervigilance were an important predictor of symptoms at the next time point.
Subject(s)
Stress Disorders, Post-Traumatic , Humans , Stress Disorders, Post-Traumatic/diagnosis , Anxiety , Checklist , Diagnostic and Statistical Manual of Mental Disorders , Ecological Momentary AssessmentABSTRACT
Imagery Rescripting (ImRs) has proven effective in reducing involuntary emotional memories. However, it is unclear whether and when it may lead to reduced accuracy of voluntary memory. Although previous analogue studies suggest that ImRs does not pose a general risk regarding memory distortion, it can not be ruled out that ImRs could cause memory impairment under certain risk conditions. In our three-day online trauma film study we investigated in a healthy sample (N = 267) whether specific instructions during ImRs as typically provided in clinical practice (i.e., detailed imagery with a sensory focus) increase the risk of memory distortions. Additionally, we examined whether the completeness of the original memory moderates these instruction effects. Contrary to our expectations, a sensory focus during ImRs was associated with higher memory accuracy in a recognition task, independently of the quality of the original memory. These results extend previous findings by suggesting that ImRs does not even impair memory performance when the quality of the original memory is poor and when the production of sensory-rich images is specifically encouraged. Our results question current practices employed to assess witness statement credibility, which are partly based on concerns that trauma-focused interventions like ImRs undermine memory accuracy.
Subject(s)
Emotions , Imagery, Psychotherapy , Humans , Imagery, Psychotherapy/methods , Memory Disorders , Cognition , Recognition, PsychologyABSTRACT
Theories propose that human affective forecasting is an adaptive learning process guided by prediction errors. Although this learning process can be formally described by a Kalman filter, human forecasts are suggested to be biased and computationally suboptimal. We compared the accuracy of human affective forecasts to statistical forecasts made using a Kalman filter and explored the differences between these two processes. Participants (from the general population) repeatedly rated current levels of affect and forecasted levels of affect that they would experience 2-3 hr later (Study 1, n = 62), 1 min later (Study 2a, n = 91), and 1-2 hr later (Study 2b, n = 87), in daily life or in experimental settings. Results showed that compared to statistical forecasts, the participants' forecasts showed larger absolute errors in hour-long forecasting (dz = 0.42 and 0.30) but not in minute-long forecasting (dz = 0.17). Relative errors were also evaluated in each study, showing no differences in Studies 1 and 2b (hour-long forecasting in daily life) but more optimistic errors in participants' than statistical forecasts in Study 2a (minute-long forecasting in an experimental setting). Across the three studies, participants exhibited a strong tendency to project their current affective experience onto a new forecast, and this may explain human-specific forecasting errors. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
Subject(s)
Forecasting , HumansABSTRACT
Trauma-focused imagery-based interventions, such as Imagery Rescripting (ImRs) and Imaginal Exposure (ImE), are effective in reducing involuntary re-experiencing in PTSD. However, it has been suggested that they may impair voluntary memory. This study investigates whether ImRs and ImE distort voluntary memory of an analogue trauma. We presented a trauma film to N = 120 healthy participants (Session 1) and randomly allocated them to one of two intervention conditions (receiving one session of ImRs or ImE) or to a no-intervention control condition (NIC) afterwards (Session 2). Voluntary memory was assessed using a free recall (Sessions 2 and 3), and a cued recall as well as a recognition task (both Sessions 3 and 4). The ImRs and ImE groups did not differ from NIC in the cued recall task and the recognition task. However, ImE (compared to ImRs and NIC) led to an increase in correct reported details in the free recall. In sum, the current findings do not suggest that ImRs or ImE impair voluntary memory.
Subject(s)
Imagery, Psychotherapy , Stress Disorders, Post-Traumatic , Humans , Cues , Mental Recall , Motion Pictures , Recognition, PsychologyABSTRACT
Adverse childhood experiences (ACE) have been linked to less prosocial behavior during social exclusion in vulnerable groups. However, little is known about the impact of the timing of ACE and the roles of protective factors. Therefore, this study investigated the association of the behavioral response to experimental partial social exclusion with adverse and adaptive experiences across age groups and resilience in clinical groups with persistent depressive disorder and borderline personality disorder, i.e., groups with high ACE, and in healthy controls (HC) (N = 140). Adverse and adaptive experiences during childhood, youth, and adulthood were assessed with the Traumatic Antecedents Questionnaire, and resilience was measured with the Connor Davidson Resilience Scale. A modified version of the Cyberball paradigm was used to assess the direct behavioral response to partial social exclusion. In patients, adverse events during youth (B = - 0.12, p = 0.016) and adulthood (B = - 0.14, p = 0.013) were negatively associated with prosocial behavior, whereas in the HC sample, adaptive experiences during youth were positively associated with prosocial behavior (B = 0.25, p = 0.041). Resilience did not mediate these effects. The findings indicate that critical events during youth may be particularly relevant for interpersonal dysfunction in adulthood.
Subject(s)
Depressive Disorder , Resilience, Psychological , Adolescent , Humans , Social Isolation , Surveys and Questionnaires , Chronic DiseaseABSTRACT
Transdiagnostic approaches challenge traditional psychiatric classification systems. Adverse childhood experiences (ACE) represent a transdiagnostic risk factor for psychopathology with dose dependency. As different qualities of ACE typically co-occur, we identified ACE patterns to assess their power for predicting psychopathology compared to traditional diagnoses. Following TRANS-D guidelines, we categorized participants (N=360) with persistent depressive disorder (PDD), borderline personality disorder (BPD), or healthy control status (HC) into subcategories defined by ACE pattern, using the Childhood Trauma Questionnaire (CTQ). Improvement of the transdiagnostic vs. diagnostic approach in predicting psychopathology was evaluated in a cross-validated predictive modeling framework focusing on the clinical sample of PDD and BPD patients. Results were externally validated in another transdiagnostic sample (N=138). Seven pattern-based subcategories with distinct ACE profiles were identified in the primary sample and replicated in the validation sample. Patterns cut across diagnostic groups. Predictive modeling showed that diagnoses could not predict depressive symptoms and loneliness. Transdiagnostic constructs systematically predicted all measures. This study showcases ACE as a promising construct for transdiagnostic research. Our data-driven framework identified robust ACE subcategories mapping onto general and interpersonal psychopathology. Patterns of CTQ-based information may provide an approach to integrating information on co-occurring ACE to inform diagnostics and treatment.
Subject(s)
Adverse Childhood Experiences , Borderline Personality Disorder , Depressive Disorder , Humans , Borderline Personality Disorder/diagnosis , Borderline Personality Disorder/psychology , Surveys and Questionnaires , Risk FactorsABSTRACT
Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems, leading to impairments in social functioning and quality of life. Refugees are at high risk for sleep problems due to stressful life circumstances and a high PTSD prevalence. However, limited data on the frequency of sleep problems in refugees with diagnosed PTSD exist. This study examined the frequency of sleep problems in refugees with PTSD and their associations with symptoms of PTSD. Additionally, we investigated the contribution of sleep problems to social functioning and quality of life. Participants (N = 70) were refugees from different countries of origin currently living in Germany. All participants met the criteria for PTSD and completed measures of PTSD symptom severity, subjective sleep problems, social impairment, and quality of life. There was a very high frequency of sleep problems in the sample (100%), and sleep problems were significantly associated with both clinician-rated, r = .47, and self-rated, r = .30, PTSD symptom severity after controlling for overlapping items. Contrary to expectations, sleep problems did not predict social impairment, d = 0.16, nor quality of life, d = 0.13, beyond the effect of other PTSD symptoms. The findings highlight the widespread frequency of sleep problems among refugees. Future studies should assess the causal nature of the association between sleep problems and measures of psychosocial functioning in more detail and examine its dynamic change over time.
Subject(s)
Refugees , Sleep Wake Disorders , Stress Disorders, Post-Traumatic , Humans , Stress Disorders, Post-Traumatic/psychology , Social Interaction , Refugees/psychology , Quality of Life/psychology , Sleep Wake Disorders/epidemiologyABSTRACT
Background: The fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) introduced the dissociative subtype of posttraumatic stress disorder (D-PTSD). To assess this subtype, the Dissociative Subtype of PTSD Scale (DSPS), a 15-item self-report measure to identify lifetime and current dissociative symptoms of D-PTSD, was developed. However, so far, the scale has only been validated in war veterans. Moreover, criterion validity and diagnostic utility have not been examined yet.Objective: We aimed to validate the DSPS in two samples of civilian trauma-exposed German-speaking participants.Methods: In Study 1, a pre-registered online study, participants with and without PTSD symptoms (N = 558) answered questionnaires about traumatic experiences, dissociation, PTSD, depression, generalized anxiety disorder, somatic symptom disorder, alcohol use disorder, absorption, and dissociative responding to trauma-related questionnaires. In Study 2, which used secondary data of a pre-registered clinical study, participants with a PTSD diagnosis (N = 71) answered questionnaires about traumatic experiences, dissociation, PTSD, depression, generalized anxiety disorder, somatic symptom disorder, and dissociative responding to standardized trauma exposure. Moreover, PTSD, D-PTSD, and other diagnoses were assessed with structured clinical interviews.Results: Analyses confirmed a three-factor structure as well as high internal consistency, and high convergent, discriminant, and criterion validity of the DSPS. Moreover, the scale was able to identify a latent D-PTSD group and individuals with D-PTSD diagnosis.Conclusions: The DSPS constitutes a reliable and valid tool to assess D-PTSD symptoms in clinical practice and research and thereby may contribute to a better understanding of these debilitating symptoms.
Many individuals with posttraumatic stress disorder (PTSD) suffer from dissociative symptoms which can be assessed with the Dissociative Subtype of PTSD Scale (DSPS; Wolf et al., 2017).The DSPS demonstrated good psychometric properties in two German-speaking trauma-exposed samples and hence might be used to assess D-PTSD symptoms in research and clinical practice.Complementing the original English version, a German version of the DSPS is provided in the Supplements.
Subject(s)
Medically Unexplained Symptoms , Stress Disorders, Post-Traumatic , Humans , Stress Disorders, Post-Traumatic/diagnosis , Psychometrics , Dissociative Disorders/diagnosis , Anxiety DisordersABSTRACT
BACKGROUND: Repetitive negative thinking (RNT) is a cognitive risk factor for various disorders. Although brief mindfulness-based interventions (MBIs; lasting 20-30 minutes or shorter) are effective tools to reduce RNT, the effect of a minimal (5-minute) MBI remains largely unknown. OBJECTIVE: We investigated the acute changes in RNT induced by a 10-day minimal MBI (body scan before sleeping) using an ecological momentary assessment (EMA) administered during the MBI training phase. In addition, we examined longer-term effects on the postintervention and 2-month follow-up assessments for questionnaire-based RNT and psychological distress. METHODS: A total of 68 participants (community sample, aged 18-55 years; n=58, 85% women) were randomly allocated to either the intervention group (n=35, 51%) or the no-training control group (n=33, 49%). Both groups completed a 10-day EMA phase of RNT, during which only the intervention group performed a daily 5-minute body scan before sleeping. RESULTS: The intervention group showed a significantly larger reduction in questionnaire-based RNT than the control group at the follow-up assessment (for growth-curve modeling analysis [GMA], dGMA=-0.91; P<.001), but this effect was not observed during the EMA phase or at the postintervention assessment. Furthermore, the intervention group showed significantly larger decreases in stress both at the postintervention (dGMA=-0.78; P<.001) and follow-up (dGMA=-0.60; P<.001) assessments than the control group. We found no intervention effects on depressive and anxiety symptoms. CONCLUSIONS: A 5-minute body scan before sleeping reduces RNT and stress when continued for at least 10 days; however, the results suggest that this effect only appears with some time lag because no acute changes during and immediately after the intervention emerged for RNT.
ABSTRACT
Trauma-focused psychotherapy (tf-PT) is the first-line treatment for posttraumatic stress disorder (PTSD). Tf-PT focuses on processing and modulating trauma memories. Not all patients benefit, however, and there is room for improvement of efficacy. Pharmacologically augmenting trauma memory modulation in the context of tf-PT may help optimise treatment outcome. To systematically review effects of pharmacologically augmented memory modulation in the context of tf-PT for PTSD (PROSPERO preregistration ID: CRD42021230623). We conducted a systematic review of randomised controlled trials of psychotherapy treatment for PTSD. We included placebo-controlled studies that augmented at least one treatment session pharmacologically targeting memory extinction or reconsolidation. We calculated post-treatment between group (pharmacological augmentation vs placebo control) effect sizes of PTSD symptom severity. We included 13 RCTs. There was large heterogeneity in augmentation procedure and methodological quality. Four studies showed significantly greater PTSD symptom reduction in the pharmacological augmentation group (propranolol, hydrocortisone, dexamethasone, D-cycloserine) compared to placebo. Seven studies showed no significant effect of pharmacological augmentation compared to placebo (D-cycloserine, rapamycin, mifepristone, propranolol, mifepristone combined with D-cycloserine, methylene blue). Two studies showed significantly smaller PTSD symptom reduction in the pharmacological augmentation group (D-cycloserine, dexamethasone) compared to placebo. Results of pharmacological augmentation were mixed overall and heterogenous for the pharmacological agents tested in more than one study. Additional studies and replications are needed to identify which pharmacological agents work, in which combination and to identify patient groups that benefit most to tailor PTSD treatment.
Subject(s)
Stress Disorders, Post-Traumatic , Humans , Cycloserine , Dexamethasone , Mifepristone/pharmacology , Mifepristone/therapeutic use , Propranolol/pharmacology , Propranolol/therapeutic use , Psychotherapy/methods , Stress Disorders, Post-Traumatic/drug therapy , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Evidence suggests that patients suffering from different mental disorders benefit from exercise programs combined with behavior change techniques. Based on this evidence, we have developed an exercise program (ImPuls) specifically designed to provide an additional treatment option in the outpatient mental health care system. The implementation of such complex programs into the outpatient context requires research that goes beyond the evaluation of effectiveness, and includes process evaluation. So far, process evaluation related to exercise interventions has rarely been conducted. As part of a current pragmatic randomized controlled trial evaluating ImPuls treatment effects, we are therefore carrying out comprehensive process evaluation according to the Medical Research Council (MRC) framework. The central aim of our process evaluation is to support the findings of the ongoing randomized controlled trial. METHODS: The process evaluation follows a mixed-methods approach. We collect quantitative data via online-questionnaires from patients, exercise therapists, referring healthcare professionals and managers of outpatient rehabilitative and medical care facilities before, during, and after the intervention. In addition, documentation data as well as data from the ImPuls smartphone application are collected. Quantitative data is complemented by qualitative interviews with exercise therapists as well as a focus-group interview with managers. Treatment fidelity will be assessed through the rating of video-recorded sessions. Quantitative data analysis includes descriptive as well as mediation and moderation analyses. Qualitative data will be analyzed via qualitative content analysis. DISCUSSION: The results of our process evaluation will complement the evaluation of effectiveness and cost-effectiveness and will, for example, provide important information about mechanisms of impact, structural prerequisites, or provider qualification that may support the decision-making process of health policy stakeholders. It might contribute to paving the way for exercise programs like ImPuls to be made successively available for patients with heterogeneous mental disorders in the German outpatient mental health care system. TRIAL REGISTRATION: The parent clinical study was registered in the German Clinical Trials Register (ID: DRKS00024152, registered 05/02/2021, https://drks.de/search/en/trial/DRKS00024152 ).
Subject(s)
Mental Disorders , Mobile Applications , Humans , Exercise , Health Personnel , Mental Disorders/diagnosis , Mental Disorders/therapy , Outpatients , Randomized Controlled Trials as Topic , Pragmatic Clinical Trials as TopicABSTRACT
OBJECTIVE: In recent years, it has been suggested that the modification of dysfunctional posttraumatic cognitions plays a central role as a mechanism of change in cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD). Indeed, several studies have shown that changes in dysfunctional posttraumatic cognitions precede and predict symptom change. However, these studies have investigated the influence on overall symptom severity-despite the well-known multidimensionality of PTSD. The present study therefore aimed to explore differential associations between change in dysfunctional conditions and change in PTSD symptom clusters. METHOD: As part of a naturalistic effectiveness study evaluating trauma-focused cognitive behavioral therapy for PTSD in routine clinical care, 61 patients with PTSD filled out measures of dysfunctional posttraumatic cognitions and PTSD symptom severity every five sessions during the course of treatment. Lagged associations between dysfunctional cognitions and symptom severity at the following timepoint were examined using linear mixed models. RESULTS: Over the course of therapy, both dysfunctional cognitions and PTSD symptoms decreased. Posttraumatic cognitions predicted subsequent total PTSD symptom severity, although this effect was at least partly explained by the time factor. Moreover, dysfunctional cognitions predicted three out of four symptom clusters as expected. However, these effects were no longer statistically significant when the general effect for time was controlled for. CONCLUSION: The present study provides preliminary evidence that dysfunctional posttraumatic cognitions predict PTSD symptom clusters differentially. However, different findings when employing a traditional versus a more rigorous statistical approach make interpretation of findings difficult. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Subject(s)
Cognitive Behavioral Therapy , Stress Disorders, Post-Traumatic , Humans , Stress Disorders, Post-Traumatic/diagnosis , Stress Disorders, Post-Traumatic/therapy , Stress Disorders, Post-Traumatic/psychology , Syndrome , Cognition , Time FactorsABSTRACT
Inflammation has an important predictive role for long-term health. This is also true when looking at the specific population of trauma survivors with PTSD. There are emerging findings showing that PTSD is related to reduced somatic health as well as evidence linking inflammation with disease outcomes in this group, such as heart diseases and early mortality, regardless of age, gender or conventional risk factors. The effectiveness of cognitive behavioral therapy for PTSD symptom severity has been demonstrated by several previous studies. In contrast, literature is scarce, yet, whether inflammation improves over the course of treatment for PTSD. Therefore, the aim of this study was to investigate whether not only PTSD symptoms, but also inflammation changes over the course of psychological treatment. Twenty-nine PTSD patients were followed while attending an outpatient clinic receiving cognitive behavioral therapy. Inflammation, determined by the C-reactive protein (CRP) assessed via the dried blood spot (DBS) technique, and symptom severity, surveyed by the PTSD Checklist for DSM-5 (PCL) were measured at 5 points before trauma-focused therapy, as well as after four, eight and twelve weeks of intervention; furthermore, a 10-month follow-up assessment was conducted. Results revealed significant improvements of PTSD symptom severity during investigation, but no significant changes in the inflammatory biomarker (CRP). Results in terms of improvement in PTSD symptom severity are in line with prior findings. The results obtained for inflammation may suggest that risk factors for somatic health consequences in PTSD patients remain despite successful psychological treatment. Further longitudinal studies are needed to fully understand the relationship between inflammation and therapeutic outcome and to develop interventions normalizing inflammation in PTSD patients.
ABSTRACT
BACKGROUND: The first onset of common mental health disorders, such as mood and anxiety disorders, mostly lies in adolescence or young adulthood. Hence, effective and scalable prevention programs for this age group are urgently needed. Interventions focusing on repetitive negative thinking (RNT) appear especially promising as RNT is an important transdiagnostic process involved in the development of depression and anxiety disorders. First clinical trials indeed show positive effects of preventative interventions targeting RNT on adult as well as adolescent mental health. Self-help interventions that can be delivered via a mobile phone app may have the advantage of being highly scalable, thus facilitating prevention on a large scale. This trial aims to investigate whether an app-based RNT-focused intervention can reduce depressive and anxiety symptoms in young people at risk for mental health disorders. METHODS: The trial will be conducted in a sample (planned N = 351) of individuals aged 16-22 years with elevated levels of RNT but no current depression or anxiety disorder. In a randomized controlled between-subjects design, two versions of the app-based self-help intervention will be compared to a waiting list control condition. The full RNT-focused intervention encompasses a variety of RNT-reducing strategies, whereas the concreteness training intervention focuses on only one of these strategies, i.e., concrete thinking. The primary outcome (depressive symptoms) and secondary outcomes (anxiety symptoms and RNT) will be measured at pre-intervention, post-intervention (6 weeks after pre-intervention), and follow-up (18 weeks after pre-intervention). DISCUSSION: This trial aims to find out whether targeting RNT via an app is an effective and feasible way of preventing depression and anxiety disorders in adolescents. Since app-based interventions are highly scalable, this trial might contribute to tackling challenges related to the increasing rates of mental health disorders among young people. TRIAL REGISTRATION: https://www.drks.de , DRKS00027384. Registered on 21 February 2022-prospectively registered.