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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04457635
Enrollment
300
Registered
2020-07-07
Start date
2013-09-30
Completion date
2016-10-31
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorder

Keywords

Return to Work, Brief Intervention

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.

Interventions

BEHAVIORALPsychotherapy

Sponsors

The Hospital of Vestfold
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor of primary outcome (sickness benefit) is masked for intervention allocation. Other outcome measures are assessed by patient questionnaires.

Intervention model description

Pragmatic randomized controled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Return to Work (RTW) to 3 months follow-upbaseline - 3 monthsTransitions from baseline to 3 months follow-up in Work Participation degree
Change in Return to Work (RTW) to 1 year follow-upbaseline - 1 yearTransitions from baseline to 1 year follow-up in Work Participation degree
Change in Return to Work (RTW) to 2 year follow-upbaseline - 2 yearTransitions from baseline to 2 year follow-up in Work Participation degree

Secondary

MeasureTime frameDescription
Clinical recovery2 yearsA minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)

Other

MeasureTime frameDescription
Self-efficacy (GSES)baseline - 2 year follow-upScore 1-4 , lower scores means worse outcome
Lfe satisfaction (LISAT)baseline - 2 year follow-upScore 1-6, lower scores means worse outcome
Beck Depression Index - II (BDI)baseline, 2 year follow-upScore 0-63, higher scores mean worse outcome
Fear avoidance beliefs -work (FABQ-work)baseline - 2 year follow-upScore 0-7, higher scores mean worse outcome
Global Perceived Effect2 year follow-upScore 0-7, lower scores means worse outcome
Illness perception (bIPC)baseline - 2 year follow-upScore 1-10, higher scores mean worse outcome
Beck Anxiety Index (BAI)baseline, 2 year follow-upScore 0-63, higher scores mean worse outcome
Hopkins Symptoms Checklist-10baseline, 2 year follow-upScore 1-4, higher scores mean worse outcome
Subjective health complaints (SHC)baseline, 2 year follow-upScore 0-29, higher scores mean worse outcome

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026