DepressionPsySysNeNCT02149381
Psychosocial Group Interventions for Depression
A study testing CBASP, Befriending and Treatment as usual in people with Depression, run by University of Eastern Finland at 1 site in Finland.
Trial summary
A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- CBASP, Befriending and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFinland
- Study dates
- May 2014to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period
Who cannot join
- Psychotic disorder
- Bipolar disorder
- Current substance abuse (excluding nicotine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.
Read the detailed description
The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric outpatient clinics. The recruition is completed.
- Conditions
- Depression
- Being tested
- CBASP, Befriending, Treatment as usual
- Keywords
- Depression, treatment as usual, CBASP, befriending
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBASPBehavioural
Cognitive behavioral group intervention for individuals suffering from chronic depression
BefriendingBehavioural
Social support intervention, sessions once per week
Treatment as usualOther
Conventional psychiatric outpatient treatment (individual counseling)
| Study group | Role | What they receive |
|---|---|---|
| CBASP | Experimental | Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks). Receives: Behavioral: CBASP; Other: Treatment as usual |
| Befriending | Active comparator | Befriending is a social support intervention Receives: Behavioral: CBASP; Other: Treatment as usual |
| Treatment as usual | Active comparator | Conventional psychiatric outpatient treatment (individual counseling) Receives: Behavioral: CBASP; Behavioral: Befriending |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Montgomery-Åsberg Depression Rating Scale
Measured: At baseline and after intervention (at 5 months)
Secondary outcomes (1)
Peripheral blood biomarkers
Blood samples are collected before and after intervention.
Measured: At baseline and after intervention (at 5 mos)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Jyväskylä Central Hospital
- Responsible party
- Sponsor
- Investigators
- Soili Lehto, Professor, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149381
- Sponsor's protocol ID
- PsySysNe
- Acronym
- PsySysNe
- Status last verified
- Nov 2017
- First submitted
- 7 Apr 2014
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02149381
- Acronym / sponsor ID
- PsySysNe / PsySysNe
- Conditions
- Depression
- Keywords
- Depression, treatment as usual, CBASP, befriending
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Jyväskylä Central Hospital
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 May 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.
A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.
Detailed description
The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric outpatient clinics. The recruition is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBASP | Experimental | Behavioral: CBASP, Other: Treatment as usualCognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks). |
| Befriending | Active comparator | Behavioral: CBASP, Other: Treatment as usualBefriending is a social support intervention |
| Treatment as usual | Active comparator | Behavioral: CBASP, Behavioral: BefriendingConventional psychiatric outpatient treatment (individual counseling) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period
Key exclusion criteria (3 listed)
- Psychotic disorder
- Bipolar disorder
- Current substance abuse (excluding nicotine)
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 |
|---|---|---|
| CBASPCognitive behavioral group intervention for individuals suffering from chronic depression | Behavioural | Befriending, CBASP, Treatment as usual |
| BefriendingSocial support intervention, sessions once per week | Behavioural | Treatment as usual |
| Treatment as usualConventional psychiatric outpatient treatment (individual counseling) | Other | Befriending, CBASP |
Primary outcome
Depression
Time frame: At baseline and after intervention (at 5 months)
Montgomery-Åsberg Depression Rating Scale
1 secondary outcome
Peripheral blood biomarkers
Time frame: At baseline and after intervention (at 5 mos)
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 24 Nov 2017.
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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.
Soili Lehto, Professor principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBASP, Befriending and Treatment as usual in people with Depression, run by University of Eastern Finland at 1 site in Finland.
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 3 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Depression (time frame: At baseline and after intervention (at 5 months)). 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 24 Nov 2017; AzTrials last refreshed its copy on 4 Nov 2026.