Viewing Study NCT04457635


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Study NCT ID: NCT04457635
Status: COMPLETED
Last Update Posted: 2020-07-07
First Post: 2020-06-26
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
Sponsor: The Hospital of Vestfold
Organization:

Study Overview

Official Title: Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.
Status: COMPLETED
Status Verified Date: 2020-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: