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

NCT ID: NCT04457635

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-10-31

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.

Conditions

Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief psychotherapy (brief PsT)

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.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

Short psychotherapy (short-PsT)

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

Group Type: ACTIVE_COMPARATOR

Psychotherapy

Intervention Type: BEHAVIORAL

Interventions

Psychotherapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital of Vestfold

OTHER

Sponsor Role: lead

Responsible Party

Aage Indahl

professor emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aage Indahl, Prof.Dr

Role: STUDY_DIRECTOR

Vestfol Hospital Trust

Other Identifiers

HVestfold

Identifier Type: -

Identifier Source: org_study_id