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

Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457635
• Other study ID #: HVestfold
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 2016

Study information

• Verified date: June 2020
• Source: The Hospital of Vestfold
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Psychotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital of Vestfold

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Depression Index - II (BDI)	Score 0-63, higher scores mean worse outcome	baseline, 2 year follow-up
Other	Beck Anxiety Index (BAI)	Score 0-63, higher scores mean worse outcome	baseline, 2 year follow-up
Other	Hopkins Symptoms Checklist-10	Score 1-4, higher scores mean worse outcome	baseline, 2 year follow-up
Other	Subjective health complaints (SHC)	Score 0-29, higher scores mean worse outcome	baseline, 2 year follow-up
Other	Self-efficacy (GSES)	Score 1-4 , lower scores means worse outcome	baseline - 2 year follow-up
Other	Lfe satisfaction (LISAT)	Score 1-6, lower scores means worse outcome	baseline - 2 year follow-up
Other	Illness perception (bIPC)	Score 1-10, higher scores mean worse outcome	baseline - 2 year follow-up
Other	Fear avoidance beliefs -work (FABQ-work)	Score 0-7, higher scores mean worse outcome	baseline - 2 year follow-up
Other	Global Perceived Effect	Score 0-7, lower scores means worse outcome	2 year follow-up
Primary	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
Primary	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
Primary	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	Clinical recovery	A minimal score on both Beck Inventories (BDI = 13 and BAI = 9)	2 years