Anxiety DisordersPhase 3NCT01565213
Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care
A Phase 3 study testing CBT, MMI and CAU in people with Anxiety Disorders and Depressive Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to compare the effects of CBT and MMI on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorders, Stress Disorders
- What is being tested?
- CBT, MMI and CAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to Sep 2010
- Phase
- Phase 3
- 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
- patients with common mental disorders or problems
Who cannot join
- patients were excluded if:
- they met diagnostic criteria for bipolar or psychotic disorder or severe personality disorder,
- were judged to be at risk of committing suicidal acts, and
- if they had undergone MMI earlier. The investigators paid no consideration to whether patients were treated with SSRI medication.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Family and Community Medicine, Karolinska Institutet,
Huddinge, 141 83
About this study
Official title: Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care: A Randomized Controlled Trial
The purpose of this study is to compare the effects of CBT and MMI on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre.
Read the detailed description
Design:
Clinical randomised non blinded controlled trial.
Setting:
The study was performed in an outpatient primary health care centre serving 36 000 inhabitants.
Participants:
Patients (n=278), aged 18-65 years, with common mental problems or disorders were referred to the study by the GPs and 245 were included in the study.
Interventions:
Participants were randomised to CAU or one of two group interventions in addition to CAU. These were: a) group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks, and b) group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.
Main outcome measures:
Primary outcome measure was the Mental Component Summary score of SF-36. Secondary outcome measures were perceived stress scale (PSS) and Self-Rating Scale for Affective Syndromes (CPRS-S-A)
- Conditions
- Anxiety Disorders, Depressive Disorders, Stress Disorders
- Being tested
- CBT, MMI, CAU
- Keywords
- primary health care,common mental disorders,, group therapy
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,
MMIBehavioural
group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.
CAUBehavioural
Care as usual by the GPs
| Study group | Role | What they receive |
|---|---|---|
| CBT cognitive behavioral therapy | Active comparator | group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks Receives: Behavioral: CBT |
| MMI Multimodal group intervention | Active comparator | group multimodal intervention Receives: Behavioral: MMI |
| CAU | Other | Care as usual given by the GPs Receives: Behavioral: CAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life as measured by the SF-36 (Mental Component Score)
Measured: Change from baseline in SF-36 at 52 weeks
Secondary outcomes (1)
Change in Psychopathology as measured by the Comprehensive Psychopathological Rating Scale Self-asssessmen (CPRS-S-A)
Measured: Change from baseline in CPRS-S-A at weeks 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJan 2006
- Primary completionSep 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kersti Ejeby, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565213
- Sponsor's protocol ID
- LS 0506-1010
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01565213
- Acronym / sponsor ID
- LS 0506-1010
- Conditions
- Anxiety Disorders, Depressive Disorders, Stress Disorders
- Keywords
- primary health care,common mental disorders,, group therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Mar 2012 (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.
The purpose of this study is to compare the effects of CBT and MMI on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre.
Detailed description
Design:
Clinical randomised non blinded controlled trial.
Setting:
The study was performed in an outpatient primary health care centre serving 36 000 inhabitants.
Participants:
Patients (n=278), aged 18-65 years, with common mental problems or disorders were referred to the study by the GPs and 245 were included in the study.
Interventions:
Participants were randomised to CAU or one of two group interventions in addition to CAU. These were: a) group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks, and b) group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.
Main outcome measures:
Primary outcome measure was the Mental Component Summary score of SF-36. Secondary outcome measures were perceived stress scale (PSS) and Self-Rating Scale for Affective Syndromes (CPRS-S-A)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT cognitive behavioral therapy | Active comparator | Behavioral: CBTgroup cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks |
| MMI Multimodal group intervention | Active comparator | Behavioral: MMIgroup multimodal intervention |
| CAU | Other | Behavioral: CAUCare as usual given by the GPs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with common mental disorders or problems
Key exclusion criteria (4 listed)
- they met diagnostic criteria for bipolar or psychotic disorder or severe personality disorder,
- were judged to be at risk of committing suicidal acts, and
- if they had undergone MMI earlier. The investigators paid no consideration to whether patients were treated with SSRI medication.
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 |
|---|---|---|
| CBTgroup cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks, | Behavioural | CBT cognitive behavioral therapy |
| MMIgroup multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks. | Behavioural | MMI Multimodal group intervention |
| CAUCare as usual by the GPs | Behavioural | CAU |
Primary outcome
Change in Quality of life as measured by the SF-36 (Mental Component Score)
Time frame: Change from baseline in SF-36 at 52 weeks
1 secondary outcome
Change in Psychopathology as measured by the Comprehensive Psychopathological Rating Scale Self-asssessmen (CPRS-S-A)
Time frame: Change from baseline in CPRS-S-A at weeks 52
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 28 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CBT, MMI and CAU in people with Anxiety Disorders and Depressive Disorders, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 4 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 28 Mar 2012. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Quality of life as measured by the SF-36 (Mental Component Score) (time frame: Change from baseline in SF-36 at 52 weeks). 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 28 Mar 2012.