NCT Number: NCT04457635
Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief versus short psychotherapy in subjects with substantial mental complaints.
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Conditions
Age range
18 year–67 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Change in Return to Work (RTW) to 3 months follow-up
Time frame: baseline - 3 months
Transitions from baseline to 3 months follow-up in Work Participation degree
-
Change in Return to Work (RTW) to 1 year follow-up
Time frame: baseline - 1 year
Transitions from baseline to 1 year follow-up in Work Participation degree
-
Change in Return to Work (RTW) to 2 year follow-up
Time frame: baseline - 2 year
Transitions from baseline to 2 year follow-up in Work Participation degree
Secondary outcomes
-
Clinical recovery
Time frame: 2 years
A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)
Other outcomes
-
Beck Depression Index - II (BDI)
Time frame: baseline, 2 year follow-up
Score 0-63, higher scores mean worse outcome
-
Beck Anxiety Index (BAI)
Time frame: baseline, 2 year follow-up
Score 0-63, higher scores mean worse outcome
-
Hopkins Symptoms Checklist-10
Time frame: baseline, 2 year follow-up
Score 1-4, higher scores mean worse outcome
-
Subjective health complaints (SHC)
Time frame: baseline, 2 year follow-up
Score 0-29, higher scores mean worse outcome
-
Self-efficacy (GSES)
Time frame: baseline - 2 year follow-up
Score 1-4 , lower scores means worse outcome
-
Lfe satisfaction (LISAT)
Time frame: baseline - 2 year follow-up
Score 1-6, lower scores means worse outcome
-
Illness perception (bIPC)
Time frame: baseline - 2 year follow-up
Score 1-10, higher scores mean worse outcome
-
Fear avoidance beliefs -work (FABQ-work)
Time frame: baseline - 2 year follow-up
Score 0-7, higher scores mean worse outcome
-
Global Perceived Effect
Time frame: 2 year follow-up
Score 0-7, lower scores means worse outcome
Sponsors and collaborators
Lead sponsor
The Hospital of Vestfold
Other
Registry information
Official study title
Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.
Important dates
- Study start
- 2013
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 7, 2020
- Registry last updated
- Jul 7, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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