Trial of Prompt Mental Health Care

Norwegian Institute of Public Health

Status: Completed

Conditions: Anxiety; Mild to Moderate Depression

Treatments: Other: Treatment as usual; Behavioral: Cognitive Behavioural Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03238872

260659

Details and patient eligibility

About

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.

Enrollment: 774 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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774 participants in 2 patient groups

Prompt Mental Health Care

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioural Therapy

Treatment as usual

Active Comparator group

Description:

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

Treatment:

Other: Treatment as usual