Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.

Study Overview
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Brief Summary
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This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief versus short psychotherapy in subjects with substantial mental complaints.

Detailed Description
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Running evaluations of the brief intervention (BI) at our outpatient clinic preceding to this study had given us the impression that the patients obtained a more active coping style towards their health problems with consequential enhanced work participation (WP). These evaluations, in addition to our experiences in BI for low back pain (LBP) has generated the current hypothesis of this study towards WP. Yet, the sustainability of WP and long-term effects on mental health remained questionable. In this pragmatic RCT the objective was to compare brief psychotherapy with focus on normalization and coping (Brief-PsT) with short-term psychotherapy of standard duration with more extended focus (Short-PsT), as otherwise used at the Mental Health services. The primary aim of this study was to assess differences in effect on WP and the secondary aim was to assess differences in clinical response. The investigators hypothesized that in the short term, Brief-PsT could facilitate or sustain WP in a superior fashion to Short-PsT in persons who are on, or at risk of sick leave due to mental health problems. Although the investigators expected a substantial long-term rate of clinical recovery and reduction in mental health-related symptoms in both groups, the investigators had no specific hypothesis regarding the extent and direction of possible group differences in these clinical measurements.

Official Title
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Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.

Conditions
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Mental Disorder

Intervention / Treatment
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* Behavioral: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 'mental complaints' was the main reason for referral to the outpatient clinic employed and on or at risk of sick leave Exclusion Criteria: acute or severe pathology that required greater input than the clinic could offer, Sick-leave had > 9 months during the preceding 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized controled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief psychotherapy (brief PsT)<br>The focus was on normalizing, accepting and coping with their present mental health complaints and their hindrance for work participation. Primarily, there was no intention to process previous pathogenic experiences. The standard duration was set on six sessions. | Behavioral: Psychotherapy<br> <br> |
| Active Comparator: Short psychotherapy (short-PsT)<br>With more extended focus, there was besides coping of mental health and challenges concerning WP, an emphasis on both an extensive anamnesis and possibility to establish a so-called central theme based on previous or current challenging issues such as trauma, difficult childhood conditions, and personality-related issues. Additional aims of the intervention could include reducing symptoms and problematic behaviour and an improvement of home situation, with deeper focus on cognitive maladaptive coping strategies or dynamic repetitions. The number of sessions was aimed to be 20 on average | Behavioral: Psychotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Return to Work (RTW) to 3 months follow-up | Transitions from baseline to 3 months follow-up in Work Participation degree | baseline - 3 months | 
| Change in Return to Work (RTW) to 1 year follow-up | Transitions from baseline to 1 year follow-up in Work Participation degree | baseline - 1 year | 
| Change in Return to Work (RTW) to 2 year follow-up | Transitions from baseline to 2 year follow-up in Work Participation degree | baseline - 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recovery | A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Return to Work, Brief Intervention