Mental DisorderNCT04457635
Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
A study testing Psychotherapy in people with Mental Disorder, run by The Hospital of Vestfold.
Trial summary
This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief versus short psychotherapy in subjects with substantial mental complaints. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 'mental complaints' was the main reason for referral to the outpatient clinic
- employed and on or at risk of sick leave
Who cannot join
- acute or severe pathology that required greater input than the clinic could offer,
- Sick-leave had > 9 months during the preceding 2 years
About this study
Official title: Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.
This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief versus short psychotherapy in subjects with substantial mental complaints.
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- Psychotherapy
- Keywords
- Return to Work, Brief Intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Return to Work (RTW) to 3 months follow-up
Transitions from baseline to 3 months follow-up in Work Participation degree
Measured: 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
Measured: 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
Measured: baseline - 2 year
Secondary outcomes (1)
Clinical recovery
A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startSep 2013
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aage Indahl, The Hospital of Vestfold
- Investigators
- Aage Indahl, Prof.Dr, Study director, Vestfol Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457635
- Sponsor's protocol ID
- HVestfold
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04457635
- Acronym / sponsor ID
- HVestfold
- Conditions
- Mental Disorder
- Keywords
- Return to Work, Brief Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized controled trial
| Arm | Type | Receives |
|---|---|---|
| Brief psychotherapy (brief PsT) | Experimental | Behavioral: PsychotherapyThe 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. |
| Short psychotherapy (short-PsT) | Active comparator | Behavioral: PsychotherapyWith 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 |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 'mental complaints' was the main reason for referral to the outpatient clinic
- employed and on or at risk of sick leave
Key exclusion criteria (2 listed)
- acute or severe pathology that required greater input than the clinic could offer,
- Sick-leave had > 9 months during the preceding 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy | Behavioural | Brief psychotherapy (brief PsT), Short psychotherapy (short-PsT) |
Primary outcome
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
1 secondary outcome
Clinical recovery
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aage Indahl, Prof.Dr study director
Vestfol Hospital Trust
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Mental Disorder, run by The Hospital of Vestfold.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Return to Work (RTW) to 3 months follow-up (time frame: baseline - 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.