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NCT Number: NCT03238872

Trial of Prompt Mental Health Care

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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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Mild to Moderate Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rask Psykisk Helsehjelp Kristiansand, Kristiansand, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Treatment as Usual

Other

Primary outcomes

  1. Recovery rate

    Time frame: Baseline to 6-month follow-up

    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).

  2. Changes in mean levels of depression and anxiety

    Time frame: Baseline to 6-month follow-up

    Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD

Secondary outcomes

  1. Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up

    Time frame: Baseline to 12-month follow-up

  2. Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.

    Time frame: Baseline to 24/36-month follow-up

  3. Work participation

    Time frame: Baseline to 12-month follow-up

    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.

  4. Functional status

    Time frame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

    Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS).

  5. Health-related quality of life

    Time frame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

    Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D).

  6. Mental Well-being

    Time frame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

    Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Collaborators

  • Göteborg University
  • Sussex Partnership NHS Foundation Trust
  • The Research Council of Norway
  • University of Bergen

Registry information

Official study title

Randomized Controlled Trial of Prompt Mental Health Care

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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