Clinical trial NCT04457635: Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
Official title: Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Keywords: Return to Work
Brief Intervention
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Return to Work (RTW) to 3 months follow-up
timeFrame: baseline - 3 months
measure: Change in Return to Work (RTW) to 1 year follow-up
timeFrame: baseline - 1 year
measure: Change in Return to Work (RTW) to 2 year follow-up
timeFrame: baseline - 2 year
Secondary outcomes:
measure: Clinical recovery
timeFrame: 2 years
Other outcomes:
measure: Beck Depression Index - II (BDI)
timeFrame: baseline, 2 year follow-up
measure: Beck Anxiety Index (BAI)
timeFrame: baseline, 2 year follow-up
measure: Hopkins Symptoms Checklist-10
timeFrame: baseline, 2 year follow-up
measure: Subjective health complaints (SHC)
timeFrame: baseline, 2 year follow-up
measure: Self-efficacy (GSES)
timeFrame: baseline - 2 year follow-up
measure: Lfe satisfaction (LISAT)
timeFrame: baseline - 2 year follow-up
measure: Illness perception (bIPC)
timeFrame: baseline - 2 year follow-up
measure: Fear avoidance beliefs -work (FABQ-work)
timeFrame: baseline - 2 year follow-up
measure: Global Perceived Effect
timeFrame: 2 year follow-up
Locations:
Study officials:
affiliation: Vestfol Hospital Trust
name: Aage Indahl, Prof.Dr
role: STUDY_DIRECTOR
References: