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

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

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

Study Overview

• Status: Completed
• Conditions: Mental Disorder
• Intervention / Treatment: Behavioral: Psychotherapy

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Psychotherapy
Active Comparator: 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	Behavioral: Psychotherapy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Index - II (BDI)	Score 0-63, higher scores mean worse outcome	baseline, 2 year follow-up
Beck Anxiety Index (BAI)	Score 0-63, higher scores mean worse outcome	baseline, 2 year follow-up
Hopkins Symptoms Checklist-10	Score 1-4, higher scores mean worse outcome	baseline, 2 year follow-up
Subjective health complaints (SHC)	Score 0-29, higher scores mean worse outcome	baseline, 2 year follow-up
Self-efficacy (GSES)	Score 1-4 , lower scores means worse outcome	baseline - 2 year follow-up
Lfe satisfaction (LISAT)	Score 1-6, lower scores means worse outcome	baseline - 2 year follow-up
Illness perception (bIPC)	Score 1-10, higher scores mean worse outcome	baseline - 2 year follow-up
Fear avoidance beliefs -work (FABQ-work)	Score 0-7, higher scores mean worse outcome	baseline - 2 year follow-up
Global Perceived Effect	Score 0-7, lower scores means worse outcome	2 year follow-up

Collaborators and Investigators

• Sponsor: The Hospital of Vestfold
• Investigators: Study Director: Aage Indahl, Prof.Dr, Vestfol Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Brief Intervention; Return to Work
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: HVestfold

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No