Trial of Prompt Mental Health Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-09

Study Completion Date

2020-09-30

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.

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Detailed Description

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Conditions

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Anxiety Mild to Moderate Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prompt Mental Health Care

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.

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Treatment as usual

Clients in the comparison group are offered treatment as usual from their general practitioner.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Interventions

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Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Treatment as usual

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No