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Trial of Prompt Mental Health Care

Primary Purpose

Anxiety, Mild to Moderate Depression

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Treatment as usual
Sponsored by
Norwegian Institute of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Depression, CBT, Outcome monitoring, Dissemination, Routine services

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rask Psykisk Helsehjelp Kristiansand
  • Rask Psykisk Helsehjelp Sandnes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prompt Mental Health Care

Treatment as usual

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recovery rate / Changes in mean levels of depression and anxiety at 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.
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.
Functional status
Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS).
Health-related quality of life
Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D).
Mental Well-being
Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).

Full Information

First Posted
August 1, 2017
Last Updated
March 10, 2021
Sponsor
Norwegian Institute of Public Health
Collaborators
The Research Council of Norway, University of Bergen, Göteborg University, Sussex Partnership NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03238872
Brief Title
Trial of Prompt Mental Health Care
Official Title
Randomized Controlled Trial of Prompt Mental Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Institute of Public Health
Collaborators
The Research Council of Norway, University of Bergen, Göteborg University, Sussex Partnership NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Mild to Moderate Depression
Keywords
Anxiety, Depression, CBT, Outcome monitoring, Dissemination, Routine services

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prompt Mental Health Care
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Clients in the comparison group are offered treatment as usual from their general practitioner.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Primary Outcome Measure Information:
Title
Recovery rate
Description
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).
Time Frame
Baseline to 6-month follow-up
Title
Changes in mean levels of depression and anxiety
Description
Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD
Time Frame
Baseline to 6-month follow-up
Secondary Outcome Measure Information:
Title
Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up
Time Frame
Baseline to 12-month follow-up
Title
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
Title
Work participation
Description
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.
Time Frame
Baseline to 12-month follow-up
Title
Functional status
Description
Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS).
Time Frame
Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
Title
Health-related quality of life
Description
Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D).
Time Frame
Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
Title
Mental Well-being
Description
Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).
Time Frame
Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Smith, PhD
Organizational Affiliation
Norwegian Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rask Psykisk Helsehjelp Kristiansand
City
Kristiansand
Country
Norway
Facility Name
Rask Psykisk Helsehjelp Sandnes
City
Sandnes
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34142636
Citation
Lervik LV, Hoffart A, Knapstad M, Smith ORF. Exploring the temporal associations between avoidance behavior and cognitions during the course of cognitive behavioral therapy for clients with symptoms of social anxiety disorder. Psychother Res. 2022 Feb;32(2):195-208. doi: 10.1080/10503307.2021.1930243. Epub 2021 Jun 18.
Results Reference
derived
PubMed Identifier
33393688
Citation
Knapstad M, Smith ORF. Social anxiety and agoraphobia symptoms effectively treated by Prompt Mental Health Care versus TAU at 6- and 12-month follow-up: Secondary analysis from a randomized controlled trial. Depress Anxiety. 2021 Mar;38(3):351-360. doi: 10.1002/da.23132. Epub 2021 Jan 4.
Results Reference
derived
Links:
URL
https://www.karger.com/Article/FullText/504453
Description
Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial

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Trial of Prompt Mental Health Care

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