Depressive Disorder, MajorNCT02314767
A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
A study testing Interpersonal Psychotherapy and Psychoeducational Group Therapy in people with Depressive Disorder, Major, run by Helsinki University Central Hospital.
Trial summary
Lohja Depression Treatment Study is a randomized treatment trial which compares three approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2) Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Interpersonal Psychotherapy and Psychoeducational Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Apr 2007
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major Depressive Disorder - diagnosed
- Comorbid anxiety disorders
Who cannot join
- Psychosis
- Suicidal patients
- Serious acute somatic illness
- Inability to read and write
- alcohol dependence or use of illicit drugs
About this study
Lohja Depression Treatment Study is a randomized treatment trial which compares three approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2) Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to test and adapt known short term treatment models for Finnish patients and circumstances.
Read the detailed description
Patients having signs of depression referred to Lohja area secondary level psychiatric clinics were assessed to the trial. After verification the diagnosis of Major Depressive Disorder (MDD) they were informed of the study. Consented patients were randomized to three study arms.
Baseline clinical demographics was collected. Psychotherapeutic treatment was implemented by specially trained therapists and the study data was collected by trained psychiatrists who were blinded to the therapy model patients has received.Primary outcome measure was 17-item Hamilton Depression Rating Scale (HAMD) and secondary outcome measures were Clinical Global Impression scale (CGI), Social and Occupational Functioning Assessment Scale ( SOFAS), Social Adaptation Scale ( Finnish translation JES) and Quality of Life assessment ( a Finnish validated questionnaire 15-D).The total of sick leave days and number of possible disability pensions in a year were assessed as well.
Assessments were implemented at the beginning, at 1,5 month, at 3 months ( which was the end of active treatment of short-term psychotherapies), at 6 months and at 12 months.
The primary assessment was planned to carry out using tests of group comparison. Sample size of 32 and 32 achieve 91% power to detect a clinically meaningful difference with a significance level (alpha) of 0.01 using two-sided two-sample t-test. Baseline differences in demographic variables and the depression measurement across the three treatment groups were tested using chi-square tests and analysis of variance.Likelihood-based inference using linear mixed models were employed to analyze treatment effects, focusing on the time x treatment interaction. Separate analyses assessed IPT-TAU and PeGT-TAU comparisons. All statistical analyses were performed using R. The aim of this study was to get a total of 140-160 patients, about 50 patients on one group.The final number of patients showed to be 134.
The statistical calculation was intent-to-treat model with consideration to missing data, because in this kind of natural setting notable attrition was assumed. The training of the therapists and researchers and quality control during assessments was considered and personnel was supervised throughout the study.
- Conditions
- Depressive Disorder, Major
- Being tested
- Interpersonal Psychotherapy, Psychoeducational Group Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
Patients were treated with IPT method, which was an active comparator vs treatment as usual
Psychoeducational Group TherapyBehavioural
Patients were treated with PeGt method which was an active comparatos vs treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy | Active comparator | Interpersonal Psychotherapy treatment for MDD patients was implemented with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression. Intervention:Interpersonal psychotherapy as ADD-on method. Outcome was compared with patients in treatment as usual group. Receives: Behavioral: Interpersonal Psychotherapy; Behavioral: Psychoeducational Group Therapy |
| Psychoeducational Group Therapy | Active comparator | Psychoeducational Group Therapy arm for MDD patients with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression. Intervention: Psychoeducational Group Treatment as ADD-on method. Receives: Behavioral: Interpersonal Psychotherapy; Behavioral: Psychoeducational Group Therapy |
| Treatment as Usual | No intervention | Treatment as usual ( consisting of supportive psychodynamic-oriented treatment) with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hamilton Rating Scale for Depression at 12 months
Measured: 12 months
Secondary outcomes (2)
Change from baseline Clinical Global Impression, severity and change at 12 months
Measured: 12 months
Change from baseline Social and Occupational Functioning Assessment Scale at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startFeb 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HSaloheimo, Helsinki University Central Hospital
- Investigators
- Heikki O Katila, MD Ph.D., Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314767
- Sponsor's protocol ID
- Lohja Depression Treatment
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Saloheimo HP, Markowitz J, Saloheimo TH, Laitinen JJ, Sundell J, Huttunen MO, A Aro T, Mikkonen TN, O Katila H. Psychotherapy effectiveness for major depression: a randomized trial in a Finnish community. BMC Psychiatry. 2016 May 6;16:131. doi: 10.1186/s12888-016-0838-1.
PubMed 27153942
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
- ClinicalTrials.gov ID
- NCT02314767
- Acronym / sponsor ID
- Lohja Depression Treatment
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
Lohja Depression Treatment Study is a randomized treatment trial which compares three approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2) Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to test and adapt known short term treatment models for Finnish patients and circumstances.
Detailed description
Patients having signs of depression referred to Lohja area secondary level psychiatric clinics were assessed to the trial. After verification the diagnosis of Major Depressive Disorder (MDD) they were informed of the study. Consented patients were randomized to three study arms.
Baseline clinical demographics was collected. Psychotherapeutic treatment was implemented by specially trained therapists and the study data was collected by trained psychiatrists who were blinded to the therapy model patients has received.Primary outcome measure was 17-item Hamilton Depression Rating Scale (HAMD) and secondary outcome measures were Clinical Global Impression scale (CGI), Social and Occupational Functioning Assessment Scale ( SOFAS), Social Adaptation Scale ( Finnish translation JES) and Quality of Life assessment ( a Finnish validated questionnaire 15-D).The total of sick leave days and number of possible disability pensions in a year were assessed as well.
Assessments were implemented at the beginning, at 1,5 month, at 3 months ( which was the end of active treatment of short-term psychotherapies), at 6 months and at 12 months.
The primary assessment was planned to carry out using tests of group comparison. Sample size of 32 and 32 achieve 91% power to detect a clinically meaningful difference with a significance level (alpha) of 0.01 using two-sided two-sample t-test. Baseline differences in demographic variables and the depression measurement across the three treatment groups were tested using chi-square tests and analysis of variance.Likelihood-based inference using linear mixed models were employed to analyze treatment effects, focusing on the time x treatment interaction. Separate analyses assessed IPT-TAU and PeGT-TAU comparisons. All statistical analyses were performed using R. The aim of this study was to get a total of 140-160 patients, about 50 patients on one group.The final number of patients showed to be 134.
The statistical calculation was intent-to-treat model with consideration to missing data, because in this kind of natural setting notable attrition was assumed. The training of the therapists and researchers and quality control during assessments was considered and personnel was supervised throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy | Active comparator | Behavioral: Interpersonal Psychotherapy, Behavioral: Psychoeducational Group TherapyInterpersonal Psychotherapy treatment for MDD patients was implemented with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression. Intervention:Interpersonal psychotherapy as ADD-on method. Outcome was compared with patients in treatment as usual group. |
| Psychoeducational Group Therapy | Active comparator | Behavioral: Interpersonal Psychotherapy, Behavioral: Psychoeducational Group TherapyPsychoeducational Group Therapy arm for MDD patients with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression. Intervention: Psychoeducational Group Treatment as ADD-on method. |
| Treatment as Usual | No intervention | –Treatment as usual ( consisting of supportive psychodynamic-oriented treatment) with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Major Depressive Disorder - diagnosed
- Comorbid anxiety disorders
Key exclusion criteria (5 listed)
- Psychosis
- Suicidal patients
- Serious acute somatic illness
- Inability to read and write
- alcohol dependence or use of illicit drugs
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 |
|---|---|---|
| Interpersonal PsychotherapyPatients were treated with IPT method, which was an active comparator vs treatment as usual | Behavioural | Interpersonal Psychotherapy, Psychoeducational Group Therapy |
| Psychoeducational Group TherapyPatients were treated with PeGt method which was an active comparatos vs treatment as usual | Behavioural | Interpersonal Psychotherapy, Psychoeducational Group Therapy |
Primary outcome
Change from baseline Hamilton Rating Scale for Depression at 12 months
Time frame: 12 months
2 secondary outcomes
Change from baseline Clinical Global Impression, severity and change at 12 months
Time frame: 12 months
Change from baseline Social and Occupational Functioning Assessment Scale at 12 months
Time frame: 12 months
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 11 Dec 2014.
- Derived from this study: PubMed 27153942Saloheimo HP, Markowitz J, Saloheimo TH, Laitinen JJ, Sundell J, Huttunen MO, A Aro T, Mikkonen TN, O Katila H. Psychotherapy effectiveness for major depression: a randomized trial in a Finnish community. BMC Psychiatry. 2016 May 6;16:131. doi: 10.1186/s12888-016-0838-1.
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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.
Heikki O Katila, MD Ph.D. study director
University of Helsinki
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy and Psychoeducational Group Therapy in people with Depressive Disorder, Major, run by Helsinki University Central Hospital.
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 5 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 11 Dec 2014. 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 from baseline Hamilton Rating Scale for Depression at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314767, which also lists 1 linked publication.
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 11 Dec 2014.