Trial of Prompt Mental Health Care

March 10, 2021 updated by: Robert Smith, Norwegian Institute of Public Health

Randomized Controlled 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

774

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway
        • Rask Psykisk Helsehjelp Kristiansand
      • Sandnes, Norway
        • Rask Psykisk Helsehjelp Sandnes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Cognitive Behavioural Therapy
Active Comparator: Treatment as usual
Clients in the comparison group are offered treatment as usual from their general practitioner.
Other: Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline to 6-month follow-up
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
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
Time Frame: Baseline to 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.
Time Frame: Baseline to 24/36-month follow-up
Baseline to 24/36-month follow-up
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.
Baseline to 12-month follow-up
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).
Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
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).
Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
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).
Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

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

Investigators

  • Principal Investigator: Robert Smith, PhD, Norwegian Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Treatment as usual

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe