Evaluating the Effects of a Self-Help Mobile Phone App on Worry and Rumination Experienced by Young Adults: Randomized Controlled Trial.

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.

Worry and rumination as a transdiagnostic target in young people: a co-produced systematic review and meta-analysis.

PROTOCOL REGISTRATION: PROSPERO (CRD42023408899).

Sudden gains in routine clinical care: application of a permutation test for trauma-focused cognitive behavioural therapy.

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.

Can an intervention designed to reduce repetitive negative thinking alter the response to a psychosocial stressor? A randomized controlled study.

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.

A transdiagnostic group exercise intervention for mental health outpatients in Germany (ImPuls): results of a pragmatic, multisite, block-randomised, phase 3 controlled trial.

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.

Dynamic symptom associations in posttraumatic stress disorder: a network approach.

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.

When does imagery rescripting become a double-edged sword? - Investigating the risk of memory distortion through imagery rescripting in an online Trauma film study.

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.

Research Into Evidence-Based Psychological Interventions Needs a Stronger Focus on Replicability.

Background: It is a precondition for evidence-based practice that research is replicable in a wide variety of clinical settings. Current standards for identifying evidence-based psychological interventions and making recommendations for clinical practice in clinical guidelines include criteria that are relevant for replicability, but a better understanding as well refined definitions of replicability are needed enabling empirical research on this topic. Recent advances on this issue were made in the wider field of psychology and in other disciplines, which offers the opportunity to define and potentially increase replicability also in research on psychological interventions. Method: This article proposes a research strategy for assessing, understanding, and improving replicability in research on psychological interventions. Results/Conclusion: First, we establish a replication taxonomy ranging from direct to conceptual replication adapted to the field of research on clinical interventions, propose study characteristics that increase the trustworthiness of results, and define statistical criteria for successful replication with respect to the quantitative outcomes of the original and replication studies. Second, we propose how to establish such standards for future research, i.e., in order to design future replication studies for psychological interventions as well as to apply them when investigating which factors are causing the (non-)replicability of findings in the current literature.

A brief measure of guilt and shame: validation of the Guilt and Shame Questionnaire (GSQ-8).

Background: Guilt and shame regulate basic human processes such as social cognition and relations. Both emotions are also involved in the aetiology and maintenance of trauma-related mental disorders such as posttraumatic stress disorder (PTSD). However, a concise scale that adequately captures these constructs is currently lacking, impeding research efforts to understand them more thoroughly.Objective: To this end, we developed the eight-item Guilt and Shame Questionnaire (GSQ-8) in English, German, and Dutch.Method: We examined the reliability and validity of the GSQ-8 in a clinical sample of adults seeking treatment for childhood-trauma-related posttraumatic stress disorder (n = 209), a sample of adults who had suffered at least one traumatic life event reporting different levels of PTSD symptoms (n = 556), and a non-clinical sample of adults (n = 156).Results: Theory-driven confirmatory factor analyses confirmed two correlated latent factors guilt and shame with four items for each factor. Across all samples, two-factor models yielded better model fit than one-factor solutions. Measurement invariance across the three samples, gender, and Dutch and German language was mostly established. Guilt and shame composite scores were associated with PTSD symptoms, depressive symptoms, life satisfaction, mental health-related quality of life, and self-blame, thus supporting scale validity. Importantly, both subscales predicted PTSD symptoms, depression, life satisfaction, and mental health-related quality of life over and above cognitions of self-blame.Conclusions: The GSQ-8 is a parsimonious, reliable, and valid tool to assess guilt and shame in clinical, sub-clinical, and non-clinical populations, allowing applications across a broad range of research questions.

We present the 8-item Guilt and Shame Questionnaire (GSQ-8), a parsimonious tool to assess guilt and shame.We found strong psychometric properties of the GSQ-8 across three samples and different languages.The GSQ-8 can be reliably used to assess shame and guilt in clinical and non-clinical work.