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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Randomized controlled trial of Prompt Mental Health Care

Alternative title: Randomisert kontrollert studie av Rask Psykisk Helsehjelp

Awarded: NOK 9.6 mill.

Anxiety and depression are together with the substance abuse among the most common mental disorders in the population. Meanwhile, access to mental health services to treat these disorders is limited. The proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%. Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of Health commissioned by the Ministry of Health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. The treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. PMHC is based on the English program "Improving Access to Psychological Therapy (IAPT)", which is established in virtually all health communities in England. The evaluations of IAPT and PMHC have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. In this study, PMHC was compared with a control group that receives treatment as usual (often provided by the general practioner). Participants were randomly assigned to either the PMHC or the control group. The inclusion period has ended as of September 1. 2017. Between November 2015 and September 2017, 1187 clients have contacted PMHC in the two participating municipalities, Sandnes and Kristiansand. Of these, 774 clients fulfilled the inclusion criteria of the study. The key objectives of this study are to investigate whether PMHC treatment is more effective compared to treatment in the control group with regard to symptoms of anxiety and depression, quality of life, and work participation. Cost-effectiveness of PMHC is also examined. The first results of the study were presented at a national network meeting for PMHC on June 12, 2018. In September 2019, the article describing these results was accepted for publication in one of the leading journals in the field ?Psychotherapy and Psychosomatics?. At 6-month follow-up, clients in the PMHC group had a recovery rate of 59% while clients in the control group had a recovery rate of 32%. Given the strong research design, this study provides evidence that PMHC is effective in reducing symptoms of anxiety and depression. PMHC treatment also improved general functioning and quality of life. The effect on work participation is still uncertain. Data from the FD-Trygd register will help to provide a more accurate estimate of this effect in the present study, but a larger study is probably needed to determine with more certainty whether PMHC also leads to increased work participation. Data at 12-month follow-up showed that the effect of PMHC was persistent. The recovery rate was 59.4% in the PMHC group and 36.6% in the control group. The effects of PMHC on general functioning and quality of life also remained stable at 12-month follow-up. In addition, the relapse rate was low compared to other international studies. In the PMHC group, a relapse rate of 10.0% was observed, while it was 16.0% in the control group. The PhD-candidate who was employed in the project has delivered the thesis in June 2021. The aim of the thesis was to generate new knowledge and insights concerning the implementation factors and mechanisms of impact associated with the PMHC services. The findings aligned with those of previous evaluations, indicating that the PMHC services manage to adhere to the key aspects of the program (i.e., reaching the target group, being low threshold and short term, having relatively short waiting times), as well as clients reporting to be content with the PMHC services. However, the need for improvements with regard to some crucial aspects was highlighted (i.e., increase the provision of guided self-help, enhance collaboration with other services, and focus on work during treatment). In terms of the mechanisms of impact within the PMHC services, none of the investigated intervention mechanisms (competence and alliance) were found to be significant contributors to the client outcomes. However, several psychometric problems with the applied measurement instrument were identified, which may have contributed to the lack of impact on the part of those mechanisms. Indications of significant client mechanisms within the PMHC services were found. When clients with symptoms related to social anxiety disorder reported changes in their avoidance behavior, it predicted changes in their social anxiety cognitions the next occasion. Targeting the avoidance behavior of primary-care clients who report symptoms of social anxiety disorder may therefore be vital to ensuring the optimal effect of therapy.

Prompt Mental Health Care (PMHC) is a program implemented in 18 selected municipalities by the Norwegian Directorate of Health (NDH). PMHC represents a new strategy for mental-health care in Norway, advertising broad, quick, and low-threshold access to evidence-based treatment for anxiety and depression. PMHC is based on the English program Improving Access to Psychological Therapies (IAPT), which has been extensively evaluated and generally shown to produce promising results. These results have influenced plans by the NDH to nationally implement PMHC in Norway by 2020. However, the IAPT evaluation has so far relied on comparing the intervention group with benchmark samples. The validity of this comparison depends of the comparability of the benchmark samples, which is difficult to assess. The proposed study aims to conduct a randomized controlled trial in two sites in order to obtain a more valid estimate of the effectiveness of PMHC. The most critical R & D challenges to be faced are ensuring treatment fidelity, cross-site consistency in terms of participant inclusion/exclusion criteria, and to minimize patient drop-out. The therapists in both PMHC and control groups are not blinded, which may influence the patients' evaluation. A number of objective outcomes, such as employment status from registry data, are included. These are less likely to be influenced by lack of blinding. The study will add to the existing body of knowledge in this field by examining to what extent the strong findings from efficacy-based evaluations of cognitive behavioural therapy can be reproduced in an effectiveness study in a new primary health care service-setting. Anticipated potential use of project findings is substantial and may guide the Norwegian Directorate of Health in the decision regarding the nationwide implementation of PMHC.

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering