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

Primary Purpose

Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
The Hospital of Vestfold
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder focused on measuring Return to Work, Brief Intervention

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Brief psychotherapy (brief PsT)

    Short psychotherapy (short-PsT)

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    Change in Return to Work (RTW) to 3 months follow-up
    Transitions from baseline to 3 months follow-up in Work Participation degree
    Change in Return to Work (RTW) to 1 year follow-up
    Transitions from baseline to 1 year follow-up in Work Participation degree
    Change in Return to Work (RTW) to 2 year follow-up
    Transitions from baseline to 2 year follow-up in Work Participation degree

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 26, 2020
    Last Updated
    June 30, 2020
    Sponsor
    The Hospital of Vestfold
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04457635
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hospital of Vestfold

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder
    Keywords
    Return to Work, Brief Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Pragmatic randomized controled trial
    Masking
    Outcomes Assessor
    Masking Description
    Outcome assessor of primary outcome (sickness benefit) is masked for intervention allocation. Other outcome measures are assessed by patient questionnaires.
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brief psychotherapy (brief PsT)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Short psychotherapy (short-PsT)
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychotherapy
    Primary Outcome Measure Information:
    Title
    Change in Return to Work (RTW) to 3 months follow-up
    Description
    Transitions from baseline to 3 months follow-up in Work Participation degree
    Time Frame
    baseline - 3 months
    Title
    Change in Return to Work (RTW) to 1 year follow-up
    Description
    Transitions from baseline to 1 year follow-up in Work Participation degree
    Time Frame
    baseline - 1 year
    Title
    Change in Return to Work (RTW) to 2 year follow-up
    Description
    Transitions from baseline to 2 year follow-up in Work Participation degree
    Time Frame
    baseline - 2 year
    Secondary Outcome Measure Information:
    Title
    Clinical recovery
    Description
    A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)
    Time Frame
    2 years
    Other Pre-specified Outcome Measures:
    Title
    Beck Depression Index - II (BDI)
    Description
    Score 0-63, higher scores mean worse outcome
    Time Frame
    baseline, 2 year follow-up
    Title
    Beck Anxiety Index (BAI)
    Description
    Score 0-63, higher scores mean worse outcome
    Time Frame
    baseline, 2 year follow-up
    Title
    Hopkins Symptoms Checklist-10
    Description
    Score 1-4, higher scores mean worse outcome
    Time Frame
    baseline, 2 year follow-up
    Title
    Subjective health complaints (SHC)
    Description
    Score 0-29, higher scores mean worse outcome
    Time Frame
    baseline, 2 year follow-up
    Title
    Self-efficacy (GSES)
    Description
    Score 1-4 , lower scores means worse outcome
    Time Frame
    baseline - 2 year follow-up
    Title
    Lfe satisfaction (LISAT)
    Description
    Score 1-6, lower scores means worse outcome
    Time Frame
    baseline - 2 year follow-up
    Title
    Illness perception (bIPC)
    Description
    Score 1-10, higher scores mean worse outcome
    Time Frame
    baseline - 2 year follow-up
    Title
    Fear avoidance beliefs -work (FABQ-work)
    Description
    Score 0-7, higher scores mean worse outcome
    Time Frame
    baseline - 2 year follow-up
    Title
    Global Perceived Effect
    Description
    Score 0-7, lower scores means worse outcome
    Time Frame
    2 year follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aage Indahl, Prof.Dr
    Organizational Affiliation
    Vestfol Hospital Trust
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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