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

NCT04457635 | Completed

• 1 other identifier: HVestfold
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Disorder

Keywords

Return to Work; Brief Intervention

Outcome Measures

Primary Outcomes (3)

• Change in Return to Work (RTW) to 3 months follow-up

  Transitions from baseline to 3 months follow-up in Work Participation degree

  baseline - 3 months

• Change in Return to Work (RTW) to 1 year follow-up

  Transitions from baseline to 1 year follow-up in Work Participation degree

  baseline - 1 year

• Change in Return to Work (RTW) to 2 year follow-up

  Transitions from baseline to 2 year follow-up in Work Participation degree

  baseline - 2 year

Secondary Outcomes (1)

• Clinical recovery

  2 years

Other Outcomes (9)

• Beck Depression Index - II (BDI)

  baseline, 2 year follow-up

• Beck Anxiety Index (BAI)

  baseline, 2 year follow-up

• Hopkins Symptoms Checklist-10

  baseline, 2 year follow-up

Study Arms (2)

Brief psychotherapy (brief PsT)

EXPERIMENTAL

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.

Behavioral: Psychotherapy

Short psychotherapy (short-PsT)

ACTIVE COMPARATOR

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

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

Brief psychotherapy (brief PsT); Short psychotherapy (short-PsT)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 'mental complaints' was the main reason for referral to the outpatient clinic
• employed and on or at risk of sick leave

You may not qualify if:

• acute or severe pathology that required greater input than the clinic could offer,
• Sick-leave had \> 9 months during the preceding 2 years

Sponsors & Collaborators

• The Hospital of Vestfold: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Aage Indahl, Prof.Dr

  Vestfol Hospital Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor of primary outcome (sickness benefit) is masked for intervention allocation. Other outcome measures are assessed by patient questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor emeritus

Model Details: Pragmatic randomized controled trial

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share