Exploring mechanisms of change in the metacognitive training for depression.

The Metacognitive Training for Depression (D-MCT) is a highly structured group therapy that has been shown to be effective in reducing depressive symptoms. First evidence suggests that need for control represents a mechanism of change. However, more research is needed to evaluate the mode of action of each module and identify predictors of treatment response. Two sequential studies (one naturalistic pilot study [study I, N = 45] and one randomized controlled trial [study II, N = 32]) were conducted to evaluate the session-specific effects and predictors of D-MCT in patients with depression. The D-MCT was conducted over eight weeks, and patients answered a questionnaire on dysfunctional beliefs (e.g., negative filter) and depressive symptoms (e.g., lack of energy, self-esteem) before and after each session. Linear mixed-effects models showed that several dysfunctional beliefs and symptoms improved over the course of the treatment; three modules were able to evoke within-session effects, but no between-session effects were found. The improvement in lack of energy in one module was identified as a relevant predictor in study I via lasso regression but was not replicated in study II. Exploratory analyses revealed further predictors that warrant replication in future studies. The identified predictors were inconclusive when the two studies were compared, which may be explained by the different instruments administered. Even so, the results may be used to revise questionnaires and improve the intervention.

Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project.

BACKGROUND: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life. METHODS: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called "Friends in Nature" or to the control group. "Friends in Nature" uses modifications of the "Circle of Friends" methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed. DISCUSSION: The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections. TRIAL REGISTRATION: Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.

Mapping evidence-based interventions to the care of unaccompanied minor refugees using a group formulation approach.

BACKGROUND: How we adapt treatment algorithms to complex, clinically untested, difficult-to-engage patient groups without losing evidence base in everyday practice is a clinical challenge. Here we describe process and reasoning for fast, pragmatic, context-relevant and service-based adaptations of a group intervention for unaccompanied minor asylum seekers (UASC) arriving in Europe. We employed a distillation-matching model and deployment-focused process in a mixed-method, top-down (theory-driven) and bottom-up (participant-informed) approach. Prevalence of mental disorders amongst UASC is extremely high. They also represent a marginalised and hard-to-engage group with limited evidence for effective treatments. METHOD: Content and process adaptations followed four steps: (1) descriptive local group characterisation and theoretical formulation of problems; (2) initial adaptation of evidenced treatment, based on problem-to-component grid; (3) iterative adaptation using triangulated feedback; and (4) small-scale pilot evaluation. RESULTS: Based on evidence and participant feedback, adaptations included minimising verbal demands, facilitating in-session inductive learning, fostering social connectedness via games, enhancing problem-solving skills, accounting for multi-traumatisation, uncertainty and deportation. Quantitative evaluation suggested improved feasibility, with increased attendance, low drop-out and symptom improvement on depression and trauma scores. CONCLUSIONS: By describing the principles under-pinning development of a group intervention for severely traumatised UASC, we contribute to the literature supporting dynamic adaptations of psychological interventions, without losing reference to evidence base. Complex and difficult-to-reach clinical groups are often those in most need of care, yet least researched and most affected by inequality of care. Pragmatic adaptations of proven programs are often necessary to increase feasibility.

Feasibility, acceptability and clinical benefit of a trauma-focused stabilisation group for post-traumatic stress disorder patients with complex presentations on primary care waitlists.

BACKGROUND: Large numbers of people showing complex presentations of post-traumatic stress disorder (PTSD) in the NHS Talking Therapies services routinely require multi-faceted and extended one-to-one National Institute of Clinical Excellence (NICE) recommended treatment approaches. This can lead to longer waits for therapy and prolong patient suffering. We therefore evaluated whether a group stabilisation intervention delivered to patients on the waitlist for individual trauma-focused psychological treatment could help address this burden. AIMS: The study aimed to ascertain a trauma-focused stabilisation group's acceptability, feasibility, and preliminary clinical benefit. METHOD AND RESULTS: Fifty-eight patients with PTSD waiting for trauma-focused individual treatment were included in the study. Two therapists delivered six 5-session groups. The stabilisation group was found to be feasible and acceptable. Overall, PTSD symptom reduction was medium to large, with a Cohen's d of .77 for intent-to-treat and 1.05 for per protocol analyses. Additionally, for depression and anxiety, there was minimal symptom deterioration. CONCLUSIONS: The study provided preliminary evidence for the acceptability, feasibility and clinical benefit of attending a psychoeducational group therapy whilst waiting for one-to-one trauma therapy.

Evaluation of the Effectiveness of a Group CBT-Based Intervention Aiming to Reduce Self-Stigma and Improve Recovery-Related Outcomes in People with Severe Mental Disorders: Randomised Controlled Trial.

Self-stigma is a major barrier to personal and clinical recovery in people with mental illness. Although psychosocial interventions have been developed to reduce self-stigma, the exploration of group CBT-based interventions for hospitalised patients are less represented. The purpose of this trial is to investigate the effectiveness of a group CBT-based intervention aiming to reduce self-stigma and improve recovery-related outcomes such as self-esteem, stigma resistance and sense of coherence, which comes down to saying, "I am what I am". A total of 104 patients admitted to the inpatient therapy were recruited to participate in a randomised controlled clinical trial, and 77 participants (46 in the intervention group and 31 in the control group) completed the trial. Constructs of interest were measured before and after the intervention. The results showed that the evaluated intervention was effective in improving sense of coherence and stigma resistance, compared to treatment as usual (TAU). The level of self-stigma significantly decreased in both the intervention and control groups, but no statistically significant difference was observed between the groups. The limitations of the study include: the lack of assessment of the sustainability of the effects of therapy (follow-up), the presence of intensive interventions of the ward's programme and patients pre-qualified for the ward based on admission criteria. The intervention "I am what I am," has proven to be effective, especially in increasing the level of personal resources needed to build clinical and personal recovery and to counteract the negative consequences of self-stigma.

Acceptability and feasibility of a short-term group therapy for people with borderline personality disorder symptoms.

OBJECTIVE: This study evaluated the acceptance, feasibility and safety of a short-term group program for adults (18 years and older) and youth (16 to 18 years) with borderline personality disorder (BPD) symptoms. Termed Road Maps, the content and development were informed by common treatment factors identified from evidence-based therapies for BPD. METHOD: Two-hundred and eight people consented to participate in the research trial and completed baseline measures. Intervention participants rated the acceptability and subjective experience of the group. Attrition rates informed feasibility, and serious adverse events were tracked to identify potential harms. RESULTS: Participant post-group ratings of the group's acceptability and subjective experience were above average across both adult and youth populations. Attrition rate after commencement of group was 38% for adults and 27% among youth. The incidence rate of emergency department presentations was reduced by 41% in the 6 months post-group, relative to 6 months pre-group. CONCLUSIONS: The current study provides preliminary support for the acceptability and feasibility of a short-term group therapy program for people with a diagnosis of BPD. Road Maps may be a useful intermediate intervention in a broader model of stepped care. Australian New Zealand Clinical Trials Registry, https://www.anzctr.org.au/ACTRN12622000849796.aspx, (ACTRN12622000849796).

Evaluating the impact of human rights education on the adjustment of Greek primary school students.

Human rights education has an encouraging effect on children's school routine. The aim of the present study was to investigate the effectiveness of a 12-session transformative human rights education intervention in improving children's school adjustment. Participants were 340 Greek primary school students assigned to intervention group (n = 187) and control group (n = 153). All members completed a written questionnaire 1 week before the implementation of the intervention, measuring their knowledge of human rights, school engagement, perceptions of the school environment, interpersonal relationships, empathy and perceptions, attitudes and feelings towards school. The completion process of the same questionnaire was repeated 1 week after the termination of the intervention and 4 months later. The results showed that the intervention was particularly beneficial as the intervention group members demonstrated a significant increase in their knowledge of human rights, school engagement, perceptions of the school environment, empathy and school liking, while experiencing a significant decrease in school avoidance and loneliness. Members of the control group did not report any significant improvement over time. The study's implications for future research on school-based human rights interventions are discussed.

Dose-Response Effects of MittEcho, a Measurement Feedback System, in an Indicated Mental Health Intervention for Children in Municipal and School Services in Norway.

Including routine client feedback can increase the effectiveness of mental health interventions for children, especially when implemented as intended. Rate of implementation, or dose, of such feedback interventions has been shown to moderate results in some studies. Variation in implementation and use of client feedback may also contribute to the mixed results observed within the feedback literature. This study evaluates dose-response associations of client feedback using a novel Measurement Feedback System (MFS) within an indicated group intervention. The primary aim was to determine whether the rate of MFS implementation predicts symptom reduction in anxiety and depression among school-aged children. The secondary aim was to assess whether the rate of MFS implementation influences children's satisfaction with the group intervention or their dropout rates. Data were collected via a randomized factorial study (clinicaltrials.gov NCT04263558) across 58 primary schools in Norway. Children aged 8 to 12 years (N = 701) participated in a group-based, transdiagnostic intervention targeting elevated symptoms of anxiety or depression. Half of the child groups also received the feedback intervention using the MittEcho MFS. Group leaders (N = 83), recruited locally, facilitated the interventions. The MFS dose was measured using the Implementation Index, which combines the use of MFS by both children and providers (group leaders) into a single dose variable. Results showed no significant additional effect of dose of MFS on change in depression or anxiety scores, on user satisfaction with the intervention or on intervention dropout. The discussion addresses potential reasons for these non-significant findings and implications for MFS implementation in preventive, group-based interventions in school settings.

ClearSpeechTogether: a Rater Blinded, Single, Controlled Feasibility Study of Speech Intervention for People with Progressive Ataxia.

BACKGROUND: Progressive ataxias frequently lead to speech disorders and consequently impact on communication participation and psychosocial wellbeing. Whilst recent studies demonstrate the potential for improvements in these areas, these treatments generally require intensive input which can reduce acceptability of the approach. A new model of care-ClearSpeechTogether-is proposed which maximises treatment intensity whilst minimising demands on clinician. This study aimed to establish feasibility and accessibility of this approach and at the same time determine the potential benefits and adverse effects on people with progressive ataxias. METHOD: This feasibility study targeted people with progressive ataxia and mild-moderate speech and gross motor impairment. ClearSpeechTogether consisted of four individual sessions over 2 weeks followed by 20 patient-led group sessions over 4 weeks. All sessions were provided online. Quantitative and qualitative data were collected for evaluation. RESULTS: Nine participants completed treatment. Feasibility and acceptability were high and no adverse effects were reported. Statistical tests found significantly reduced vocal strain, improved reading intelligibility and increased participation and confidence. Participant interviews highlighted the value of group support internalisation of speech strategies and psycho-social wellbeing. DISCUSSION: ClearSpeechTogether presented a feasible, acceptable intervention for a small cohort of people with progressive ataxia. It matched or exceeded the outcomes previously reported following individual therapy. Particularly notable was the fact that this could be achieved through patient led practice without the presence of a clinician. Pending confirmation of our results by larger, controlled trials, ClearSpeechTogether could represent an effective approach to manage speech problems in ataxia.

Improving emotion regulation in breast cancer patients in the early survivorship period: Efficacy of a brief ecologically boosted group intervention.

PURPOSE: This study reports the short- and mid-term benefits of an eight-session emotion and self-regulation group intervention ecologically boosted through daily app-based prompts. The intervention was designed for breast cancer patients in the early survivorship period meeting criteria for clinical levels of psychological symptoms. METHODS: Patients were randomly assigned to the immediate intervention arm (n = 61; intervention received immediately) or to the delayed intervention arm (n = 59; intervention received 5 months later). Psychological symptoms, including anxiety, depressive symptoms, emotional distress, fear of cancer recurrence (FCR), worry, and intrusive thoughts were assessed through questionnaires. Emotion regulation was assessed in a dynamic emotion regulation task and in everyday life. Assessments were completed at baseline (T1), 5 months (T2) and 10 months (T3) later. RESULTS: Treated patients reported lower levels of worry and intrusive thoughts. They improved their ability to down-regulate the intensity of their negative emotions when exposed to cancer-related triggers in the dynamic emotion regulation task. They reported fewer and less intense negative emotions and more positive emotions in their everyday life. Benefits were maintained 5 months later, except for positive emotions in everyday life. CONCLUSIONS: The results showed that focusing on emotion regulation is a relevant approach in the treatment of psychological symptoms for breast cancer patients in the early survivorship period meeting criteria for clinical levels of psychological symptoms. The intervention led to changes in patients' dynamic and everyday life emotion regulation. Consolidation sessions may be needed to sustain benefits in positive emotions and to increase the effect sizes.

A peer group intervention implemented by community volunteers increased HIV prevention knowledge.

BACKGROUND: HIV prevention knowledge levels are low in sub-Saharan Africa. In our efficacy study, the Mzake ndi Mzake (Friend-to-Friend; hereafter Mzake) 6-session peer group intervention, delivered by health workers, improved HIV prevention knowledge and other outcomes in Malawi. To expand HIV prevention approaches, this implementation study tested whether the intervention remained effective when implemented by trained community volunteers. HIV prevention knowledge findings are presented. METHODS: Using a stepped wedge design, three communities implemented the Mzake program sequentially in randomly assigned order. Repeated surveys assessed outcomes, and participants served as controls until they completed the program. At Time 2, Community 1 became the intervention group, and at Time 3, Communities 1 and 2 were the intervention group. HIV prevention knowledge, the primary outcome, was assessed through two indicators: UNAIDS comprehensive knowledge (UNAIDS Knowledge), defined as correctly answering five HIV prevention questions (Yes/No), and a 9-item HIV/PMTCT Knowledge Index (number correct). Multivariate generalized estimating equation logistic regression (UNAIDS Knowledge) and mixed-effects regression models (HIV/PMTCT Knowledge Index) were used to assess knowledge controlling for five sociodemographic factors. RESULTS: In bivariate analyses of UNAIDS Knowledge, more persons answered correctly in the intervention group than the control group at Time 2 (56.8% vs. 47.9%, p < 0.01), but the difference was not significant at Time 3. In logistic regression, there was a significant linear increase in the proportion who correctly answered all questions in the control group, but the increase was significantly higher in the intervention group (log-odds estimate = 0.17, SE = 0.06, p-value < 0.01). The HIV/PMTCT Knowledge Index scores increased over time for both groups, but in the intervention group the increase was significantly higher than the control group (0.11 at Time 2; 0.21 at Time 3). In youth and adult subsamples analyses, the intervention was highly effective in increasing knowledge for youth, but not for adults. CONCLUSION: This implementation study showed that Mzake was effective in increasing HIV prevention knowledge when delivered by community members. Community approaches offer an important strategy to increase HIV prevention in rural communities without burdening healthcare systems. TRIAL REGISTRATION: ClinicalTrials.gov NCT02765659. Registered 06/05/2016.

Mother-Infant Group Intervention on Maternal Depression and Bonding: A Quasi-Experimental Study.

OBJECTIVES: Parent-Infant Psychotherapy (PIP) aims at improving the interaction between parents and their infants. Group intervention has advantages in facilitating universality, support, and social learning. However, the researches on PIP adoption in a group format are limited. This study aims to explore the outcome of a mother-infant group on bonding and maternal depression. METHODS: Eighty-two infant mothers with subjective distress on parenting or depressed mood were recruited to participate in the intervention group (IG). Another sample of one hundred and ninety-four postpartum women was recruited as the control group (CG). Instruments for outcome measure were the Mother-Infant Bonding Scale, Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Inventory-Second Edition (BDI-II), and Social Network Interaction System Questionnaire. Twelve courses of mother-infant groups were conducted for IG women. Each course consisted of twelve 90-min sessions. IG women joined the intervention with their infants and replied to the instruments at baseline, post-intervention, and follow-up. CG women replied to the instruments at similar intervals. Primary data analyses were performed by the intent-to-treat analysis, ANOVA, and GEE. RESULTS: Relative to CG participants, the IG women experienced significant benefits in most mother-infant bonding scores at both post-intervention and follow-up (ps = .000 - .026). IG women also experienced a greater reduction in follow-up depressive symptoms measured by EPDS (p = .023). However, no significant reduction was noted on BDI-II. CONCLUSIONS: Mother-infant group intervention has preliminary effects on improving bonding and reducing depressive symptoms for women with infants. Further studies are warranted to replicate the results.

Literature indicates detrimental impacts of adverse bonding and maternal depression on children development. Parent-infant group psychotherapy suggests a positive effect on facilitating bonding and reducing depression severity. However, the evidence is limited and inconclusive. Since the treatment has never been applied in Taiwan, its effect and feasibility on Taiwanese women is unknown. The results established a preliminary positive outcome of parent-infant group on maternal bonding and depression. Also, by the first practice, we observe the participants have well motivation to join intervention with their infants and with other women. Parent-infant group is a promising treatment that warranted further exploration.

Testing the Effects of a Multicomponent Frailty Management Program for Community-Dwelling Older Adults in Singapore: A Feasibility Study.

Frailty in later life is often associated with functional declines and reduced quality of life. A multicomponent frailty management program (mFMP) is lacking in Singapore. This study aimed to determine the feasibility and effects of an mFMP in reducing frailty and increasing participation among frail community-living older adults. Pre- and postassessments at three time points were conducted to compare the differences in body functions between the mFMP (experimental group [EG]) and a fitness program (control group [CG]). Recruitment, dropouts, and fall data were collected. Weekly field notes and semistructured interviews postintervention were thematically analyzed. Sixteen out of 23 participants (EG: eight; CG: eight) completed the 12-week interventions with reduced frailty immediately postintervention. At 3-month postintervention, 10 participants (EG: five; CG: five) being followed up had a sustained level of frailty (p < .05). The EG and CG reported zero and two falls, respectively. The mFMP demonstrated its feasibility and exhibited a trend to facilitate personal behavioral changes postintervention.

Online cognitive-behavioral group intervention for young adult survivors of childhood cancer: a pilot study.

BACKGROUND: Young adult childhood cancer survivors (YACCS) are a vulnerable group in need of psychosocial support, but tailored interventions are lacking. AIM: To examine feasibility and satisfaction, and to explore preliminary effectiveness of an online group intervention (Op Koers Online for YACCS) aimed at teaching active coping skills and providing peer-contact, thereby reducing and preventing psychosocial problems in YACCS. The intervention is based on psycho-education, cognitive behavioral therapy, and aspects of acceptance and commitment therapy. METHODS: YACCS completed questionnaires pre- and post-intervention. Feasibility was based on attendance, drop-out, and an evaluation questionnaire was administered to assess satisfaction. Preliminary effectiveness was evaluated with the Mastery Scale, Illness Cognition Questionnaire, Distress Thermometer, Impact of Cancer - Childhood Survivors, and Pediatric Quality of Life Inventory. Preliminary effectiveness was investigated by testing differences on the psychosocial outcomes (coping and psychosocial wellbeing) between T0 and T1 within respondents, using paired samples t tests and Cohen's d. RESULTS: 10 YACCS participated in the intervention and completed all questionnaires. There was no drop-out; 90% of participants attended five out of six sessions. Overall, participants were satisfied with the intervention; 7.6 on a 0-10 scale. Distress (Cohen's d=-.6, p=.030) and feelings of helplessness (Cohen's d=-.8, p=.001) reduced from T0 to T1, while self-efficacy (Cohen's d=.8, p=.013,) improved. Other outcomes displayed small effects, but did not change significantly. CONCLUSIONS: This first, small pilot study showed short-term decrease in distress and feelings of helplessness and improvement of self-efficacy. Op Koers Online was positively evaluated by YACCS and course leaders, filling a gap in psychosocial services for YACCS.

An Examination of the 4 Rs 2 Ss for Problem Behaviors: A Preventive Approach.

Early treatment of behavioral problems can prevent their progression into intractable disorders. This study examined the impact of a multiple family group (MFG) intervention for children with behavior symptoms and their families. Fifty-four (n = 54) caregiver/child dyads with sub-clinical levels of oppositional defiant disorder (ODD) participated in a 16-week MFG. Child, caregiver, and family outcomes were assessed at baseline, post-treatment, and at 6 months follow-up. Significant decreases in impairment with parents, family members, and peers, and improvements in child self-esteem were found from baseline to follow-up. Caregiver stress increased; no significant changes in depression or perceived social support were found over time. The effectiveness of MFG as a preventive approach and areas of future research are discussed.

"Staying Home - Feeling Positive": Effectiveness of an on-line positive psychology group intervention during the COVID-19 pandemic.

The current study investigated the effectiveness of a group on-line positive psychology intervention (OPPI) designed to mitigate the psychological impact of the COVID-19 pandemic and the subsequent measures to control it. Study participants (N = 82, M age = 33.07, SD = 9.55) were all Greek adults divided into an intervention (n = 44) and a control group (n = 38). The intervention group attended a voluntary, online, two-week, six-session (each 50 min), group intervention. The intervention aimed at enhancing participants' personal strengths and resilience in order to cope more effectively with the psychological impact of social distancing (e.g., feelings of anxiety, sadness, fear, and/or loneliness). All participants completed an online questionnaire one week before the intervention's implementation, which included scales measuring their: demographic characteristics, empathy, resilience, affectivity, feelings of loneliness, depression and anxiety levels, and feelings of fear regarding the outbreak. Participants in both the intervention and control group completed the same measures the week following the intervention's termination to examine its effects, and two weeks later to examine its long-term effectiveness. The intervention was found to be effective in alleviating the impact of the pandemic and in strengthening participants' resilience. More specifically, the results showed significant decreases for the intervention group in all measures of psychosocial distress (anxiety, depression, loneliness and fear) and significant increases in empathy, resilience, and experience of positive emotions. The study's implications for the development and implementation of online psychological interventions during a crisis are discussed.

Long term outcome study of a salutogenic psychoeducational recovery oriented intervention (Inte.G.R.O.) in severe mental illness patients.

AIM: Inte.G.R.O. is a standardized Salutogenic-Psychoeducational intervention designed to help people with severe mental illness manage their life-stress and achieve personal recovery goals through the improvement of social functioning. The aim of this study is to evaluate the long-term outcome of this approach, characterized by health promotion rather than correction of dysfunctional strategies. METHODS: 41 people underwent an observational study with a three time-point evaluation (t0, pre- treatment; t1, 12 months; t2, 36 months). At each time point, social functioning was assessed as primary outcome by the Personal and Social Functioning scale (PSP); furthermore, psychopathological status was assessed by Brief Psychiatric Rating Scale (BPRS), stress management was measured by means of Stress-Scale and cognitive flexibility variables were assessed by Modified Five-Point Test (M-FPT). RESULTS: Personal and Social Functioning increased at t1 and t2 vs t0; psychopathological status improved at t2 vs t0; stress management improved at t2 vs t1; cognitive flexibility improved at t2 vs t0. CONCLUSIONS: these results substantially confirm after a three-year follow-up the improvements in functioning, psychopathology, stress management and cognitive flexibility seen in previous studies. Furthermore, they show a complex time-dependent fashion. Overall, they confirm a remarkable and long-term impact of Inte.G.R.O. on key Recovery variables. Further studies are needed to address extent and duration of these improvements.

A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol.

BACKGROUND: The integration of a personal recovery-oriented practice in mental health services is an emerging principle in policy planning. Self-management support (SMS) is an intervention promoting recovery that aims at educating patients on the nature of their mental disorder, improving their strategies to manage their day-to-day symptoms, fostering self-efficacy and empowerment, preventing relapse, and promoting well-being. While SMS is well established for chronic physical conditions, there is a lack of evidence to support the implementation of structured SMS programs for common mental disorders, and particularly for anxiety disorders. This study aims to examine the effectiveness of a group-based self-management support program for anxiety disorders as an add-on to treatment-as-usual in community-based care settings. METHODS/DESIGN: We will conduct a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. TREATMENT AND CONTROL GROUPS: a) group self-management support (10 weekly 2.5-h group web-based sessions with 10-15 patients with two trained facilitators); b) treatment-as-usual. Participants will include adults meeting DSM-5 criteria for Panic Disorder, Agoraphobia, Social Anxiety Disorder, and/or Generalized Anxiety Disorder. The primary outcome measure will be the Beck Anxiety Inventory; secondary outcome measures will comprise self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. STATISTICAL ANALYSIS: Data will be analysed based on intention-to-treat with a mixed effects regression model accounting for between and within-subject variations in the effects of the intervention. DISCUSSION: This study will contribute to the limited knowledge base regarding the effectiveness of structured group self-management support for anxiety disorders. It is expected that changes in patients' self-management behaviour will lead to better anxiety management and, consequently, to improved patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05124639 . Prospectively registered 18 November 2021.

Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial.

BACKGROUND: Syrian refugees resettled in Turkey show a high prevalence of symptoms of mental disorders. Problem Management Plus (PM+) is an effective psychological intervention delivered by non-specialist health care providers which has shown to decrease psychological distress among people exposed to adversity. In this single-blind pilot randomised controlled trial, we examined the methodological trial procedures of Group PM+ (gPM+) among Syrian refugees with psychological distress in Istanbul, Turkey, and assessed feasibility, acceptability, perceived impact and the potential cost-effectiveness of the intervention. METHODS: Refugees with psychological distress (Kessler Psychological Distress Scale, K10 > 15) and impaired psychosocial functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16) were recruited from the community and randomised to either gPM+ and enhanced care as usual (E-CAU) (n = 24) or E-CAU only (n = 22). gPM+ comprised of five weekly group sessions with eight to ten participants per group. Acceptability and feasibility of the intervention were assessed through semi-structured interviews. The primary outcome at 3-month follow-up was symptoms of depression and anxiety (Hopkins Symptoms Checklist-25). Psychosocial functioning (WHODAS 2.0), symptoms of posttraumatic stress disorder and self-identified problems (Psychological Outcomes Profiles, PSYCHLOPS) were included as secondary outcomes. A modified version of the Client Service Receipt Inventory was used to document changes in the costs of health service utilisation as well as productivity losses. RESULTS: There were no barriers experienced in recruiting study participants and in randomising them into the respective study arms. Retention in gPM+ was high (75%). Qualitative analyses of the interviews with the participants showed that Syrian refugees had a positive view on the content, implementation and format of gPM+. No adverse events were reported during the implementation. The study was not powered to detect an effect. No significant difference between gPM+ and E-CAU group on primary and secondary outcome measures, or in economic impacts were found. CONCLUSIONS: gPM+ delivered by non-specialist peer providers seemed to be an acceptable, feasible and safe intervention for Syrian refugees in Turkey with elevated levels of psychological distress. This pilot RCT sets the stage for a fully powered RCT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03567083 ; date: 25/06/2018.

Feasibility trial of a telehealth support group intervention to reduce anxiety in multiple sclerosis.

OBJECTIVE: Anxiety is common among persons with MS (PwMS), but widely accepted treatments are lacking. Group-based interventions delivered via telehealth are an accessible treatment option requiring clinical trial evidence to support feasibility and initial efficacy. We conducted a pilot feasibility trial of an online support group intervention to reduce anxiety in PwMS. METHODS: A non-randomized, parallel arm clinical trial was conducted. A total of 31 PwMS were enrolled: 20 completed a 12-week telehealth-delivered support group intervention and 11 were assigned to a survey-only control group. Primary feasibility outcomes were adherence and completion rates. Primary efficacy outcome was anxiety, secondary outcomes were depression, loneliness, distress, self-efficacy, stress, and quality of life. RESULTS: Twenty-six participants completed the study. Intervention group adherence (75%) and completion (85%) rates were acceptable. Results indicated a medium size between-group effect, suggesting a greater reduction in anxiety in the intervention group compared to the control group [U = 39.50, p = 0.045, r = 0.39]. No group differences in other outcomes were observed. CONCLUSION: A telehealth-delivered support group intervention appears feasible for further study and shows initial efficacy for the reduction of anxiety in PwMS.