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Trial of Prompt Mental Health Care

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ClinicalTrials.gov Identifier: NCT03238872
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Anxiety Mild to Moderate Depression Behavioral: Cognitive Behavioural Therapy Other: Treatment as usual

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Prompt Mental Health Care
Actual Study Start Date : November 9, 2015
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238872

Contact: Robert Smith, PhD +4794236412 robert.smith@fhi.no

Rask Psykisk Helsehjelp Kristiansand Active, not recruiting
Kristiansand, Norway
Rask Psykisk Helsehjelp Sandnes Recruiting
Sandnes, Norway
Contact: Lene Hoset Sunde, MSc    +4791861671    lene.hoset.sunde@sandnes.kommune.no   
Sponsors and Collaborators
Norwegian Institute of Public Health
The Research Council of Norway
University of Bergen
Göteborg University
Sussex Partnership NHS Foundation Trust
Principal Investigator: Robert Smith, PhD Norwegian Institute of Public Health
More Information

Responsible Party: Robert Smith, Researcher, Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT03238872     History of Changes
Other Study ID Numbers: 260659
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Smith, Norwegian Institute of Public Health:
Outcome monitoring
Routine services

Additional relevant MeSH terms:
Behavioral Symptoms