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Completed

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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Key information

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

Psychotherapy

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Clinical recovery

    Time frame: 2 years

    A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)

Other outcomes

  1. Beck Depression Index - II (BDI)

    Time frame: baseline, 2 year follow-up

    Score 0-63, higher scores mean worse outcome

  2. Beck Anxiety Index (BAI)

    Time frame: baseline, 2 year follow-up

    Score 0-63, higher scores mean worse outcome

  3. Hopkins Symptoms Checklist-10

    Time frame: baseline, 2 year follow-up

    Score 1-4, higher scores mean worse outcome

  4. Subjective health complaints (SHC)

    Time frame: baseline, 2 year follow-up

    Score 0-29, higher scores mean worse outcome

  5. Self-efficacy (GSES)

    Time frame: baseline - 2 year follow-up

    Score 1-4 , lower scores means worse outcome

  6. Lfe satisfaction (LISAT)

    Time frame: baseline - 2 year follow-up

    Score 1-6, lower scores means worse outcome

  7. Illness perception (bIPC)

    Time frame: baseline - 2 year follow-up

    Score 1-10, higher scores mean worse outcome

  8. Fear avoidance beliefs -work (FABQ-work)

    Time frame: baseline - 2 year follow-up

    Score 0-7, higher scores mean worse outcome

  9. 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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