Concentrated transdiagnostic and cross-disciplinary micro-choice based group treatment for patients with depression and with anxiety leads to lasting improvements after 12 months: a pilot study.

BACKGROUND: A concentrated transdiagnostic and micro choice-based group treatment for patients with depression and anxiety has previously shown to yield significant reduction in symptoms and increased level of functioning from pre to 3-month follow-up. In the present study, we report the results after 12 months follow-up. METHODS: This was a non-randomized clinical intervention pilot study, conducted in line with a published protocol. Sixty-seven consecutively referred patients, aged 19-47 (mean age 32.5, SD = 8.0) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age at onset of symptoms was 17.6 (SD = 7.9) years. Mean number of prior treatment courses was 3.5 (SD = 3.3; range 0-20). The main objective was to assess the treatment effectiveness by questionnaires measuring relevant symptoms at pre-treatment, 7 days-, 3 months-, 6 months- and at 12-months follow-up. RESULTS: Validated measures of functional impairment (WSAS), depression (PHQ9), anxiety (GAD7), worry (PSWQ), fatigue (CFQ), insomnia (BIS) and illness perception (BIPQ) improved significantly (p < .0005) from before treatment to 12 months follow-up, yielding mostly large to extremely large effect sizes (0.89-3.68), whereas some moderate (0.60-0.76). After 12 months, 74% report an overall improvement in problems related to anxiety and depression. Utilization of specialist, public and private mental health care was reported as nonexistent or had decreased for 70% of the patients at 12-month follow up. CONCLUSIONS: The concentrated, micro-choice based group treatment approach yielded a highly clinically significant reduction in a wide range of symptoms already one week after treatment, and the positive results persisted at 12-month follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05234281, first posted date 10/02/2022.

First trans-diagnostic experiences with a novel micro-choice based concentrated group rehabilitation for patients with low back pain, long COVID, and type 2 diabetes: a pilot study.

BACKGROUND: The health care is likely to break down unless we are able to increase the level of functioning for the growing number of patients with complex, chronic illnesses. Hence, novel high-capacity and cost-effective treatments with trans-diagnostic effects are warranted. In accordance with the protocol paper, we aimed to examine the acceptability, satisfaction, and effectiveness of an interdisciplinary micro-choice based concentrated group rehabilitation for patients with chronic low back pain, long COVID, and type 2 diabetes. METHODS: Patients with low back pain > 4 months sick-leave, long COVID, or type 2 diabetes were included in this clinical trial with pre-post design and 3-month follow-up. The treatment consisted of three phases: (1) preparing for change, (2) the concentrated intervention for 3-4 days, and (3) integrating change into everyday life. Patients were taught and practiced how to monitor and target seemingly insignificant everyday micro-choices, in order to break the patterns where symptoms or habits contributed to decreased levels of functioning or increased health problems. The treatment was delivered to groups (max 10 people) with similar illnesses. Client Satisfaction Questionnaire (CSQ-8)) (1 week), Work and Social Adjustment Scale (WSAS), Brief Illness Perception Questionnaire (BIPQ), and self-rated health status (EQ-5D-5L) were registered at baseline and 3-month follow-up. RESULTS: Of the 241 included participants (57% women, mean age 48 years, range 19-84), 99% completed the concentrated treatment. Treatment satisfaction was high with a 28.9 (3.2) mean CSQ-8-score. WSAS improved significantly from baseline to follow-up across diagnoses 20.59 (0.56) to 15.76 (0.56). BIPQ improved from: 22.30 (0.43) to 14.88 (0.47) and EQ-5D-5L: 0.715 (0.01) to 0.779 (0.01)), all P<0.001. CONCLUSIONS: Across disorders, the novel approach was associated with high acceptability and clinically important improvements in functional levels, illness perception, and health status. As the concentrated micro-choice based treatment format might have the potential to change the way we deliver rehabilitation across diagnoses, we suggest to proceed with a controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05234281.

Relationship between exercise capacity and fatigue, dyspnea, and lung function in non-hospitalized patients with long COVID.

Long COVID is a global health problem that impairs patients' functional status. More than 200 reported symptoms have been identified where fatigue, dyspnea, and exercise impairment are most common. This study aimed to describe exercise capacity, fatigue, dyspnea, and lung function in previously non-hospitalized patients with long COVID, and examine the relationship between exercise capacity and fatigue, dyspnea, and lung function. Sixty-five patients, 54 women (83%), mean age of 39 standard deviation (12) years, were included and completed spirometry, cardiopulmonary exercise test, stair climbing test (SCT), 30 second sit-to-stand test (30STST), and questionnaires regarding fatigue and dyspnea. Fatigue was reported by 95% of the participants, whereas 65% reported severe fatigue, and 66% reported dyspnea. Mean exercise capacity measured with peak oxygen uptake (V̇O2peak % pred.) was ≥85% in 65% of the participants. Mean forced expiratory volume in 1 s. and forced vital capacity were 96.6 (10.7)% and 100.8 (10.9)%, respectively, while reduced diffusion capacity for carbon monoxide (DLCO ) was found in eight participants (13%). Reduced V̇O2peak kg-1 and increased time on SCT were significantly associated with increased dyspnea and reduced DLCO but not with fatigue, while 30STST was associated with increased fatigue and dyspnea in previously non-hospitalized patients with long COVID.

A safe and effective micro-choice based rehabilitation for patients with long COVID: results from a quasi-experimental study.

At least 65 million people suffer from long COVID. Treatment guidelines are unclear, especially pertaining to recommendations of increased activity. This longitudinal study evaluated safety, changes in functional level and sick leave following a concentrated rehabilitation program for patients with long COVID. Seventy-eight patients (19-67 years) participated in a 3-day micro-choice based rehabilitation program with 7-day and 3-month follow-up. Fatigue, functional levels, sick leave, dyspnea and exercise capacity were assessed. No adverse events were reported and 97.4% completed the rehabilitation. Fatigue measured with Chalder Fatigue Questionnaire decreased at 7-days [mean difference (MD = - 4.5, 95% CI - 5.5 to - 3.4) and 3-month (MD = - 5.5, 95% CI - 6.7 to - 4.3). Sick leave rates and dyspnea were reduced (p < 0.001) and exercise capacity and functional level increased (p < 0.001) at 3-month follow-up regardless of severity of fatigue at baseline. Micro-choice based concentrated rehabilitation for patients with long COVID was safe, highly acceptable and showed rapid improvements in fatigue and functional levels, sustaining over time. Even though this is a quasi-experimental study, the findings are of importance addressing the tremendous challenges of disability due to long COVID. Our results are also highly relevant for patients, as they provide the base for an optimistic outlook and evidence supported reason for hope.

Concentrated transdiagnostic and cross-disciplinary group treatment for patients with depression and with anxiety: a pilot study.

BACKGROUND: A number of treatment approaches have shown efficacy for depression and/or anxiety, yet there is a paucity of research on potentially cost-effective concentrated approaches. Based on our previous experience with concentrated treatment in disorders such as Obsessive-Compulsive Disorder and chronic fatigue, we proposed that this novel approach could be useful for other conditions, including depression and/or anxiety. As a pre-requisite for a future randomized controlled trial, the aim of this study was to investigate the acceptability, satisfaction and effectiveness of a transdiagnostic, interdisciplinary group treatment delivered during 5 consecutive days to groups of 6-10 patients with depression and/or anxiety. METHODS: This was a non-randomized clinical intervention pilot study in line with a published protocol. Forty-two consecutively referred patients, aged 19-47 (mean age 31.7, SD = 8.12) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age when the symptoms became a problem was 20.9 years. Mean number of prior treatment courses was 2.77 (SD = 2.19; range 0-8). Acceptability was defined as the proportion of eligible patients who accepted and completed the treatment. Satisfaction was evaluated by Client Satisfaction Questionnaire-8. Secondary objectives were to assess the treatment effectiveness by questionnaires at pre-treatment, seven days post-treatment and three months follow-up. RESULTS: The treatment was highly acceptable (91.3% accepted, all completed), and patients were highly satisfied with the treatment, including the amount. Functional impairment, as measured by Work and Social Adjustment Scale (WSAS) improved significantly (p < .0005) from "severe" (mean 25.4 SD = 6.59) to "less severe" (mean 13.37, SD = 9.43) at 3 months follow-up. Using the Generalized Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9), the effect sizes at 3 months follow-up were 1.21 for anxiety and 1.3 for depression. More than 80% reported reduced utilization of mental health care, and 67% had not used, or had used the family doctor less, for anxiety or depression. 52% had not used, or had reduced, medication for their disorder. CONCLUSIONS: The concentrated, interdisciplinary treatment approach yielded promising results. Long-term follow up is warranted. TRIAL REGISTRATION: This study is registered in Clinical Trials, identifier NCT05234281 and approval date 09/02/2022.

Evaluation of Novel Concentrated Interdisciplinary Group Rehabilitation for Patients With Chronic Illnesses: Protocol for a Nonrandomized Clinical Intervention Study.

BACKGROUND: An aging population with a growing burden of chronic complex illnesses will seriously challenge the public health care system. Consequently, novel and efficacious treatment approaches are highly warranted. Based on our experiences with concentrated treatment formats for other health challenges, we developed a highly concentrated interdisciplinary group rehabilitation approach for chronic illnesses. OBJECTIVE: We aim to explore the acceptability of the intervention and describe potential changes in functional impairment at follow-up. METHODS: The cornerstones of the intervention are as follows: (1) prepare the patient for change prior to treatment, (2) focus on health promoting microchoices instead of symptoms, and (3) expect the patient to integrate the changes in everyday living with limited hands-on follow-up. The intervention will be delivered to patients with highly diverse primary symptoms, namely patients with low back pain, post-COVID-19 symptoms, anxiety and depression, and type 2 diabetes. RESULTS: Recruitment started between August 2020 and January 2021 (according to the illness category). For initial 3-month results, recruitment is expected to be completed by the end of 2021. CONCLUSIONS: If successful, this study may have a substantial impact on the treatment of low back pain, post-COVID-19 symptoms, anxiety and depression, and type 2 diabetes, which together constitute a major socioeconomic cost. Further, the study may widen the evidence base for the use of the concentrated treatment format in a diverse group of medical conditions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32216.

The seven Cs of the high acceptability of home-based VCT: results from a mixed methods approach in Zambia.

HIV testing and counselling is a critical gateway to prevention and treatment. Yet, coverage remains insufficient, few couples are tested together and gender differences in access exist. We used an embedded mixed methods approach to investigate possible explanations for the high acceptance of home-based voluntary HIV counselling and testing (HB-VCT) in a pair-matched cluster-randomized trial in Zambia. A baseline survey included 1694 individuals in 36 clusters. Adults in 18 intervention clusters were offered HB-VCT by lay counsellors. Standard testing services were available in both trial arms. After the completion of the intervention, a follow-up survey was conducted in all trial clusters. In addition, 21 in-depth interviews and one focus group discussion were conducted with home-based VCT clients in the intervention arm. Informants favoured the convenience, confidentiality and credibility of HB-VCT. Counsellors were perceived as trustworthy owing to their closeness and conduct, and the consent process was experienced as convincing. Couple testing was selected by 70% of cohabiting couples and was experienced as beneficial by both genders. Levels of first-time testing (68% vs. 29%, p < 0.0001) and re-testing (94% vs. 74%, p < 0.0001) were higher in the intervention than in the control arm. Acceptance of HIV testing and counselling is dependent on stigma, trust and gender. The confidentiality of home-based VCT was essential for overcoming stigma-related barriers, and the selection of local counsellors was important to ensure trust in the services. The high level of couple counselling within HB-VCT may contribute to closing the gender gap in HIV testing, and has benefits for both genders and potentially for prevention of HIV transmission. The study demonstrates the feasibility of achieving high test coverage with an opt-in consent approach. The embedded qualitative component confirmed the high satisfaction with HB-VCT reported in the quantitative survey and was crucial to fully understand the intervention and its consequences.

Strong effects of home-based voluntary HIV counselling and testing on acceptance and equity: a cluster randomised trial in Zambia.

Home-based voluntary HIV counselling and testing (HB-VCT) has been reported to have a high uptake, but it has not been rigorously evaluated. We designed a model for HB-VCT appropriate for wider scale-up, and investigated the acceptance of home-based counselling and testing, equity in uptake and negative life events with a cluster-randomized trial. Thirty six rural clusters in southern Zambia were pair-matched based on baseline data and randomly assigned to the intervention or the control arm. Both arms had access to standard HIV testing services. Adults in the intervention clusters were offered HB-VCT by local lay counsellors. Effects were first analysed among those participating in the baseline and post-intervention surveys and then as intention-to-treat analysis. The study was registered with www.controlled-trials.com, number ISRCTN53353725. A total of 836 and 858 adults were assigned to the intervention and control clusters, respectively. In the intervention arm, counselling was accepted by 85% and 66% were tested (n = 686). Among counselled respondents who were cohabiting with the partner, 62% were counselled together with the partner. At follow-up eight months later, the proportion of adults reporting to have been tested the year prior to follow-up was 82% in the intervention arm and 52% in the control arm (Relative Risk (RR) 1.6, 95% CI 1.4-1.8), whereas the RR was 1.7 (1.4-2.0) according to the intention-to-treat analysis. At baseline the likelihood of being tested was higher for women vs. men and for more educated people. At follow-up these differences were found only in the control communities. Measured negative life events following HIV testing were similar in both groups. In conclusion, this HB-VCT model was found to be feasible, with a very high acceptance and to have important equity effects. The high couple counselling acceptance suggests that the home-based approach has a particularly high HIV prevention potential.

Effects of home-based voluntary counselling and testing on HIV-related stigma: findings from a cluster-randomized trial in Zambia.

HIV-related stigma continues to be a prominent barrier to testing, treatment and care. However, few studies have investigated changes in stigma over time and the factors contributing to these changes, and there is no evidence of the impact of HIV testing and counselling on stigma. This study was nested within a pair-matched cluster-randomized trial on the acceptance of home-based voluntary HIV counselling and testing conducted in a rural district in Zambia between 2009 and 2011, and investigated changes in stigma over time and the impact of HIV testing and counselling on stigma. Data from a baseline survey (n = 1500) and a follow-up survey (n = 1107) were used to evaluate changes in stigma. There was an overall reduction of seven per cent in stigma from baseline to follow-up. This was mainly due to a reduction in individual stigmatizing attitudes but not in perceived stigma. The reduction did not differ between the trial arms (ß = -0.22, p = 0.423). Being tested for HIV was associated with a reduction in stigma (ß = -0.57, p = 0.030), and there was a trend towards home-based Voluntary Counselling and Testing having a larger impact on stigma than other testing approaches (ß = -0.78, p = 0.080 vs. ß = -0.37, p = 0.551), possibly explained by a strong focus on counselling and the safe environment of the home. The reduction observed in both arms may give reason to be optimistic as it may have consequences for disclosure, treatment access and adherence. Yet, the change in stigma may have been affected by social desirability bias, as extensive community mobilization was carried out in both arms. The study underscores the challenges in measuring and monitoring HIV-related stigma. Adjustment for social desirability bias and inclusion of qualitative methods are recommended for further studies on the impact of HIV testing on stigma.

The burden of knowing: balancing benefits and barriers in HIV testing decisions. a qualitative study from Zambia.

BACKGROUND: Client-initiated HIV counselling and testing has been scaled up in many African countries, in the form of voluntary counselling and testing (VCT). Test rates have remained low, with HIV-related stigma being an important barrier to HIV testing. This study explored HIV testing decisions in one rural and one urban district in Zambia with high HIV prevalence and available antiretroviral treatment. METHODS: Data were collected through 17 in-depth interviews and two focus group discussions with individuals and 10 in-depth interviews with counsellors. Interpretive description methodology was employed to analyse the data. RESULTS: 'To know your status' was found to be a highly charged concept yielding strong barriers against HIV testing. VCT was perceived as a diagnostic device and a gateway to treatment for the severely ill. Known benefits of prevention and early treatment were outweighed by a perceived burden of knowing your HIV status related to stigma and fear. The manner in which the VCT services were organised added to this burden. CONCLUSIONS: This study draws on social stigma theory to enhance the understanding of the continuity of HIV related stigma in the presence of ART, and argues that the burden of knowing an HIV status and the related reluctance to get HIV tested can be understood both as a form of label-avoidance and as strong expressions of the still powerful embodied memories of suffering and death among non-curable AIDS patients over the last decades. Hope lies in the emerging signs of a reduction in HIV related stigma experienced by those who had been tested for HIV. Further research into innovative HIV testing service designs that do not add to the burden of knowing is needed.

Home-based voluntary HIV counselling and testing found highly acceptable and to reduce inequalities.

BACKGROUND: Low uptake of voluntary HIV counselling and testing (VCT) in sub-Saharan Africa is raising acceptability concerns which might be associated with ways by which it is offered. We investigated the acceptability of home-based delivery of counselling and HIV testing in urban and rural populations in Zambia where VCT has been offered mostly from local clinics. METHODS: A population-based HIV survey was conducted in selected communities in 2003 (n = 5035). All participants stating willingness to be HIV tested were offered VCT at home and all counselling was conducted in the participants' homes. In the urban area post-test counselling and giving of results were done the following day whereas in rural areas this could take 1-3 weeks. RESULTS: Of those who indicated willingness to be HIV tested, 76.1% (95%CI 74.9-77.2) were counselled and received the test result. Overall, there was an increase in the proportion ever HIV tested from 18% before provision of home-based VCT to 38% after. The highest increase was in rural areas; among young rural men aged 15-24 years up from 14% to 42% vs. for urban men from 17% to 37%. Test rates by educational attainment changed from being positively associated to be evenly distributed after home-based VCT. CONCLUSIONS: A high uptake was achieved by delivering HIV counselling and testing at home. The highest uptakes were seen in rural areas, in young people and groups with low educational attainment, resulting in substantial reductions in existing inequalities in accessing VCT services.