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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| University of Bergen | OTHER |
| Göteborg University | OTHER |
| Sussex Partnership NHS Foundation Trust |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prompt Mental Health Care | Experimental | 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. |
|
| Treatment as usual | Active Comparator | Clients in the comparison group are offered treatment as usual from their general practitioner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy | Behavioral |
| ||
| Treatment as usual |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate / Changes in mean levels of depression and anxiety at 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. | Baseline to 24/36-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Smith, PhD | Norwegian Institute of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rask Psykisk Helsehjelp Kristiansand | Kristiansand | Norway | ||||
| Rask Psykisk Helsehjelp Sandnes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41366421 | Derived | Andersen AIO, Knapstad M, Smith ORF. Can registry-based auxiliary variables improve handling of missing outcome data in mental health trials? Evidence from a registry-linked randomized study. Trials. 2025 Dec 9;27(1):33. doi: 10.1186/s13063-025-09346-z. | |
| 37226210 | Derived | Hanevik E, Rovik FMG, Boe T, Knapstad M, Smith ORF. Client predictors of therapy dropout in a primary care setting: a prospective cohort study. BMC Psychiatry. 2023 May 24;23(1):358. doi: 10.1186/s12888-023-04878-7. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| OTHER |
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| Other |
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| 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 |
| 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. |
| 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. |
| 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. |
| Sandnes |
| Norway |
| 34142636 | Derived | 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. |
| 33393688 | Derived | 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. |