Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders

NCT01805583 | Completed

• 1 other identifier: 2012/2109-31/5
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence-based clinical treatments for common mental disorders, such as CBT and/or pharmacotherapy, have resulted in significant and sustained improvement in clinical symptoms. However, the individual-focused treatments rarely have sickness absence as a target of intervention or evaluate work-related outcomes, such as return to work. A recent review of the evidence for managing stress at work showed that individual interventions give effects on mental health measures but did not impact absenteeism at work. The purpose of this study is to examine the efficacy and cost-effectiveness of two different rehabilitation models, one based on psychotherapy and the other on workplace-interventions, when these are offered as standalone interventions and in combination for patients with adjustment, anxiety and depressive disorders.

Conditions

Adjustment Disorders; Anxiety Disorders; Depression

Outcome Measures

Primary Outcomes (1)

• Return to work

  Primary outcome measure is RTW based on register data on number of sick leave days from the National Insurance Office (NIO), self-reported data regarding short-term absence (periods of less than 14 days, that is not registered at NIO) and self-reported work ability according to scores in the Work Ability Index (WAI). The primary outcome will be reported as change over time from inclusion and at 6, 12, 24 and 60 months.

  at 6, 12, 24 and 60 months

Secondary Outcomes (5)

• Changes in symptom severity of depression

  at 6, 12, 24 and 60 months

• Changes in symptom severity of anxiety

  at 6, 12, 24 and 60 months

• Changes in score of burnout symptoms

  at 6, 12, 24 and 60 months

• Changes in scores of General function

  at 6, 12, 24 and 60 months

• Changes in scores of general satisfaction with life

  at 6, 12, 24 and 60 months

Study Arms (4)

ACT

EXPERIMENTAL

The ACT intervention consists of 6 manual-based face-to-face sessions and internet-based homework modules. The manual is based on the six core processes in the ACT-model: acceptance, mindfulness, defusion, self as context, values and committed action.

Other: Acceptance and Commitment Therapy (ACT)

WPI

EXPERIMENTAL

This interventions aims at the facilitation of dialogue between the participant and the workplace through a series of steps consisting of individual interviews with the participant and his/her nearest supervisor and a so called "convergence dialogue meeting" in order to agree upon short- and long-term solutions.

Other: workplace intervention (WPI)

ACT and WPI

EXPERIMENTAL

The study participants receive both ACT and WPI. The ACT intervention consists of 6 manual-based face-to-face sessions and internet-based homework modules. The manual is based on the six core processes in the ACT-model: acceptance, mindfulness, defusion, self as context, values and committed action. WPI aims at the facilitation of dialogue between the participant and the workplace through a series of steps consisting of individual interviews with the participant and his/her nearest supervisor and a so called "convergence dialogue meeting" in order to agree upon short- and long-term solutions.

Other: Acceptance and Commitment Therapy (ACT); Other: workplace intervention (WPI)

Control group

NO INTERVENTION

Treatment as usual (TAU) which means that the participant continues in ordinary health care and does not receive interventions other than the initial assessment.

Interventions

Acceptance and Commitment Therapy (ACT) OTHER

ACT; ACT and WPI

workplace intervention (WPI) OTHER

ACT and WPI; WPI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Employment grade at 50% minimum. On Sick-leva for at least 1-12 moths due to adjustment, anxiety or depressive disorders.

You may not qualify if:

• Patients with addiction disorders, schizophrenia, psychotic disorders high suicidal risk, bipolar disorder, severe depression or generalized anxiety disorder. Patients on current psychotherapy. Patients that do not speak and write Swedish.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

FORUM-Centrum för psykiatrforskning, Danderyds sjukhus

Stockholm, 182 88, Sweden

Location

Related Publications (1)

• Finnes A, Ghaderi A, Dahl J, Nager A, Enebrink P. Randomized controlled trial of acceptance and commitment therapy and a workplace intervention for sickness absence due to mental disorders. J Occup Health Psychol. 2019 Feb;24(1):198-212. doi: 10.1037/ocp0000097. Epub 2017 Sep 28.

  PMID: 28956942 DERIVED

MeSH Terms

Conditions

Adjustment Disorders; Anxiety Disorders; Depression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anna Nager, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: March 6, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 21, 2016

Record last verified: 2016-03

Locations

SE (1)