Trial of Prompt Mental Health Care

Anxiety Clinical Trial

Official title:

Randomized Controlled Trial of Prompt Mental Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238872
• Other study ID #: 260659
• Status: Completed
• Phase: N/A
• Start date: November 9, 2015
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2021
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: September 30, 2020
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mild to Moderate Depression

Intervention

Behavioral:
• Cognitive Behavioural Therapy

Other:
• Treatment as usual

Locations

Country	Name	City	State
Norway	Rask Psykisk Helsehjelp Kristiansand	Kristiansand
Norway	Rask Psykisk Helsehjelp Sandnes	Sandnes

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health	Göteborg University, Sussex Partnership NHS Foundation Trust, The Research Council of Norway, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	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
Primary	Changes in mean levels of depression and anxiety	Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD	Baseline to 6-month follow-up
Secondary	Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up		Baseline to 12-month follow-up
Secondary	Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.		Baseline to 24/36-month follow-up
Secondary	Work participation	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
Secondary	Functional status	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.
Secondary	Health-related quality of life	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.
Secondary	Mental Well-being	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.

External Links

•   Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial