Trial of Prompt Mental Health Care

Study Overview
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Brief Summary
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Anxiety and depression are among the most common mental disorders in the population. Anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner annually. The majority of this amount is accounted for by anxiety and depression disorders. 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 is compared with a control group that receives treatment as usual (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and Sandnes). Participants are randomly assigned to either the PMHC or the control group. The investigators aim to include 1100 clients in the study. The key objectives of this study are to investigate whether PMHC treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. Cost-effectiveness of PMHC is also examined.

Official Title
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Randomized Controlled Trial of Prompt Mental Health Care

Conditions
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Anxiety, Mild to Moderate Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PHQ-9/GAD-7 scores above cut off Level Being above 18 years of age and a resident in the pilot sites Basic verbal and oral Norwegian proficiency Exclusion Criteria: Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, invaliding anxiety, psychotic symptoms, severe substance abuse, and personality disorder. Two or more previous treatment attempts without effect. Serious physical health problem as prime problem

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prompt Mental Health Care<br>Clients in the experimental group receive short-term cognitive behavioural therapy in the form of a psycho-educational group course, guided self-help, or individual face-to-face therapy. | Behavioral: Cognitive Behavioural Therapy<br> <br> |
| Active Comparator: Treatment as usual<br>Clients in the comparison group are offered treatment as usual from their general practitioner. | Other: Treatment as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate | Proportion of clients that have recovered based on predefined cut-offs for the Patient Health Questionnaire (PHQ<10) and Generalized Anxiety Disorder scale (GAD<8). | Baseline to 6-month follow-up | 
| Changes in mean levels of depression and anxiety | Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD | Baseline to 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up |  | Baseline to 12-month follow-up | 
| Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only. |  | Baseline to 24/36-month follow-up | 
| Work participation | Increased or maintained work participation at 6 and 12 month follow-up, defined as maintained work participation, new employment or a full or partial return-to-work. Both questionnaire and registry-based data are used for this purpose. | Baseline to 12-month follow-up | 
| Functional status | Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS). | Baseline to 12-month follow-up; for experimental group to 36-month follow-up. | 
| Health-related quality of life | Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D). | Baseline to 12-month follow-up; for experimental group to 36-month follow-up. | 
| Mental Well-being | Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS). | Baseline to 12-month follow-up; for experimental group to 36-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Depression, CBT, Outcome monitoring, Dissemination, Routine services