RESUMO
Perceived stress, a global health problem associated with various mental disorders, is assumed to be influenced by dysfunctional beliefs. It can be hypothesized that these beliefs can be modified with the help of approach-avoidance modification trainings (AAMTs). In the present study (conducted 2020-2022), we aimed to clarify whether the efficacy of AAMTs can be enhanced by utilizing the expression of emotions to move AAMT stimuli. For this purpose, we tested the feasibility and acceptability of a new AAMT paradigm in which the expression of disgust is used to move stress-increasing beliefs away from oneself and the expression of positive emotions is used to move stress-reducing beliefs towards oneself (AAMT-DP). Additionally, we explored the therapeutic potential of the AAMT-DP intervention by comparing it to an inactive control condition and to a conventional AAMT in which stimuli are moved by swipe movements (n = 10 in each condition). The primary outcome was perceived stress 1 week after the training as assessed with the Perceived Stress Scale. Findings indicate sufficient feasibility and acceptability of the intervention and that the decrease in perceived stress in the AAMT-DP condition was greater than in the inactive control condition (g = 0.72 [0.10, 1.72]) and than in the swipe control condition (g = 0.64 [0.01, 1.41]). In sum, findings provide preliminary evidence for the feasibility, acceptability, and the therapeutic potential of the AAMT-DP intervention.
Assuntos
Asco , Estresse Psicológico , Humanos , Projetos Piloto , Estresse Psicológico/psicologia , Masculino , Feminino , Adulto , Aprendizagem da Esquiva , Adulto Jovem , Estudos de Viabilidade , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Stress levels and thus the risk of developing related physical and mental health conditions are rising worldwide. Dysfunctional beliefs contribute to the development of stress. Potentially, such beliefs can be modified with approach-avoidance modification trainings (AAMT). As previous research indicates that effects of AAMTs are small, there is a need for innovative ways of increasing the efficacy of these interventions. For this purpose, we aim to evaluate the feasibility of the intervention and study design and explore the efficacy of an innovative emotion-based AAMT version (eAAMT) that uses the display of emotions to move stress-inducing beliefs away from and draw stress-reducing beliefs towards oneself. METHODS: We will conduct a parallel randomized controlled pilot study at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany. Individuals with elevated stress levels will be randomized to one of eight study conditions (n = 10 per condition) - one of six variants of the eAAMT, an active control intervention (swipe-based AAMT), or an inactive control condition. Participants in the intervention groups will engage in four sessions of 20-30 min (e)AAMT training on consecutive days. Participants in the inactive control condition will complete the assessments via an online tool. Non-blinded assessments will be taken directly before and after the training and 1 week after training completion. The primary outcome will be perceived stress. Secondary outcomes will be dysfunctional beliefs, symptoms of depression, emotion regulation skills, and physiological stress measures. We will compute effect sizes and conduct mixed ANOVAs to explore differences in change in outcomes between the eAAMT and control conditions. DISCUSSION: The study will provide valuable information to improve the intervention and study design. Moreover, if shown to be effective, the approach can be used as an automated smartphone-based intervention. Future research needs to identify target groups benefitting from this intervention utilized either as stand-alone treatment or an add-on intervention that is combined with other evidence-based treatments. TRIAL REGISTRATION: The trial has been registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS00023007 ; September 7, 2020).
RESUMO
BACKGROUND: A key vulnerability factor in mental health problems is chronic stress. There is a need for easy-to-disseminate and effective interventions to advance the prevention of stress-related illnesses. App-based stress management trainings can fulfill this need. As subjectively experienced stress may be influenced by dysfunctional beliefs, modifying their evaluations might reduce subjective stress. Approach-avoidance modification trainings (AAMT) can be used to modify stimulus evaluations and are promising candidates for a mobile stress intervention. As the standard training reactions of the AAMT (swiping and joystick motion) have little valence, emotions could be incorporated as approach and avoidance reactions to enhance the effectiveness of AAMTs. OBJECTIVE: We aimed to evaluate the feasibility of a mobile emotion-enhanced AAMT that engages users to display sadness to move stress-enhancing beliefs away and display positive emotions to move stress-reducing beliefs toward themselves (emotion-based AAMT using sadness and positive emotions [eAAMT-SP]). We explored the clinical efficacy of this novel intervention. METHODS: We allocated 30 adult individuals with elevated stress randomly to 1 of 3 conditions (eAAMT-SP, a swipe control condition, and an inactive control condition). We evaluated the feasibility of the intervention (technical problems, adherence, usability, and acceptability). To explore the clinical efficacy of the intervention, we compared pretest-posttest differences in perceived stress (primary clinical outcome) and 3 secondary clinical outcomes (agreement with and perceived helpfulness of dysfunctional beliefs, emotion regulation, and depressive symptoms) among the conditions. RESULTS: The predetermined benchmarks of 50% for intervention completion and 75% for feasibility of the study design (completion of the study design) were met, whereas the cutoff for technical feasibility of the study design (95% of trials without technical errors) was not met. Effect sizes for usability and acceptability were in favor of the eAAMT-SP condition (compared with the swipe control condition; intelligibility of the instructions: g=-0.86, distancing from dysfunctional beliefs: g=0.22, and approaching functional beliefs: g=0.55). Regarding clinical efficacy, the pretest-posttest effect sizes for changes in perceived stress were g=0.80 for the comparison between the eAAMT-SP and inactive control conditions and g=0.76 for the comparison between the eAAMT-SP and swipe control conditions. Effect sizes for the secondary clinical outcomes indicated greater pretest-posttest changes in the eAAMT-SP condition than in the inactive control condition and comparable changes in the swipe control condition. CONCLUSIONS: The findings regarding the feasibility of the intervention were satisfactory except for the technical feasibility of the intervention, which should be improved. The effect sizes for the clinical outcomes provide preliminary evidence for the therapeutic potential of the intervention. The findings suggest that extending the AAMT paradigm through the use of emotions may increase its efficacy. Future research should evaluate the eAAMT-SP in sufficiently powered randomized controlled trials. TRIAL REGISTRATION: German Clinical Trials Registry DRKS00023007; https://drks.de/search/en/trial/DRKS00023007.
RESUMO
Oxytocin administration during a trauma analogue has been shown to increase intrusive memories, which are a core symptom of post-traumatic stress disorder (PTSD). However, it is unknown whether oxytocin influences the acquisition or the consolidation of the trauma. The current study investigates the effect of the activation of the oxytocin system during the consolidation of an analogue trauma on the formation of intrusive memories over four consecutive days and whether this effect is influenced by individual neurobiological, genetic, or psychological factors. We conducted a randomized double-blind placebo-controlled study in 217 healthy women. They received either a single dose of intranasal oxytocin (24 IU) or placebo after exposure to a trauma film paradigm, which reliably induces intrusive memories. We used a general random forest to examine a potential heterogeneous treatment effect of oxytocin on the consolidation of intrusive memories. Furthermore, we used a poisson regression to examine whether salivary alpha amylase activity (sAA) as a marker of noradrenergic activity and cortisol response to the film, polygenic risk score (PRS) for psychiatric disorders, and psychological factors influence the number of intrusive memories. We found no significant effect of oxytocin on the formation of intrusive memories (F(2, 543.16) = 0.75, p = 0.51, ηp2 = 0.00) and identified no heterogeneous treatment effect. We replicated previous associations of the PRS for PTSD, sAA and the cortisol response on intrusive memories. We further found a positive association between high trait anxiety and intrusive memories, and a negative association between the emotion regulation strategy reappraisal and intrusive memories. Data of the present study suggest that the consolidation of intrusive memories in women is modulated by genetic, neurobiological and psychological factors, but is not influenced by oxytocin. Trial registration: NCT03875391.
Assuntos
Consolidação da Memória , Transtornos de Estresse Pós-Traumáticos , Humanos , Feminino , Hidrocortisona , Ocitocina/farmacologia , Efeito Placebo , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Transtornos de Estresse Pós-Traumáticos/psicologiaRESUMO
iKNOW is the first evidence-based digital tool to support personalized counseling for women in Germany with a hereditary cancer risk. The counseling tool is designed for carriers of pathogenic gBRCA (germline breast cancer gene) variants that increase the lifetime risk of breast and ovarian cancer. Carriers of pathogenic variants are confronted with complex, individualized risk information, and physicians must be able to convey this information in a comprehensible way to enable preference-sensitive health decisions. In this paper, we elaborate on the clinical, regulatory, and practical premises of personalized counseling in Germany. By operationalizing these premises, we formulate 5 design principles that, we suggest, are specific enough to develop a digital tool (eg, iKNOW), yet wide-ranging enough to inform the development of counseling tools for personalized medicine more generally: (1) digital counseling tools should implement the current standard of care (eg, based on guidelines); (2) digital counseling tools should help to both standardize and personalize the counseling process (eg, by enabling the preference-sensitive selection of counseling contents from a common information base); (3) digital counseling tools should make complex information easy to access both cognitively (eg, by using evidenced-based risk communication formats) and technically (eg, by means of responsive design for various devices); (4) digital counseling tools should respect the counselee's data privacy rights (eg, through strict pseudonymization and opt-in consent); and (5) digital counseling tools should be systematically and iteratively evaluated with the users in mind (eg, using formative prototype testing to ensure a user-centric design and a summative multicenter, randomized controlled trial). On the basis of these paradigmatic design principles, we hope that iKNOW can serve as a blueprint for the development of more digital innovations to support personalized counseling approaches in cancer medicine.