Somatisation DisorderStress-4NCT01518647
Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)
A study testing Acceptance and Commitment Therapy in people with Somatisation Disorder and Somatoform Disorders, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Somatisation Disorder, Somatoform Disorders
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jan 2012to 9 Feb 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
- Moderate or severe impact on daily life
- Symptoms lasting for at least 2 years
- Age 20-50 years
- Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
Who cannot join
- Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
- Patients with treatment demanding psychiatric disease as dominating problem
- A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- Abuse of alcohol, narcotics or drugs
- Pregnancy at time of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Multi-organ Bodily Distress Syndrome. A Randomized Controlled Trial of the Effects of Acceptance and Commitment Therapy Given as Group Therapy or Workshop Compared to Standard Treatment (Stress-4)
The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of treatment, a 9-session group therapy and a 1-day workshop followed by an individual consultation, and both are compared to standard treatment, which is one single advisory consultation. The study includes 180 patients.
Read the detailed description
The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a three-armed randomized controlled trial of ACT treatment given as a supplement to standard treatment as either 9-session group therapy or as a 1-day workshop followed by an individual consultation, compared to standard treatment, which is one single advisory consultation.
Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study includes 180 participants.
- Conditions
- Somatisation Disorder, Somatoform Disorders
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Bodily Distress Syndrome, Medically unexplained symptoms, Functional somatic symptoms, Functional somatic syndromes, Treatment, Acceptance and Commitment Therapy
- Medical subject headings
- Somatoform Disorders, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
| Study group | Role | What they receive |
|---|---|---|
| Group Therapy | Experimental | ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month Receives: Behavioral: Acceptance and Commitment Therapy |
| Workshop | Experimental | ACT given as a one-day workshop with 15 patients with a following individual consultation Receives: Behavioral: Acceptance and Commitment Therapy |
| Standard treatment | Active comparator | Standard treatment is one single advisory consultation given 2 weeks after randomization Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Clinical Improvement Scale
Questionnaire, patient-rated improvement of health since the beginning of the study.
Measured: 14 month after randomization
Secondary outcomes (4)
SF-36
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Measured: Before randomization, and at 6, 14 and 20 months after randomization
Visual Analogue Scale for pain and worst symptom
Measured: Before randomization, and at 6, 14 and 20 month after randomization
Symptom Checklist (SCL)
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Measured: Before randomization, and at 6, 14 and 20 month after randomization
WHODAS II
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Measured: Before randomization, and at 6, 14 and 20 month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study start25 Jan 2012
- Primary completion25 Aug 2015
- Study completion9 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatisation 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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanne L Agger, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518647
- Sponsor's protocol ID
- M-20110265
- Acronym
- Stress-4
- Status last verified
- May 2017
- First submitted
- 13 Jan 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Multi-organ Bodily Distress Syndrome. A Randomized Controlled Trial of the Effects of Acceptance and Commitment Therapy Given as Group Therapy or Workshop Compared to Standard Treatment (Stress-4)
- ClinicalTrials.gov ID
- NCT01518647
- Acronym / sponsor ID
- Stress-4 / M-20110265
- Conditions
- Somatisation Disorder, Somatoform Disorders
- Keywords
- Bodily Distress Syndrome, Medically unexplained symptoms, Functional somatic symptoms, Functional somatic syndromes, Treatment, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- 25 Aug 2015 (actual)
- Study completion
- 9 Feb 2016 (actual)
- First posted
- 26 Jan 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 aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of treatment, a 9-session group therapy and a 1-day workshop followed by an individual consultation, and both are compared to standard treatment, which is one single advisory consultation. The study includes 180 patients.
Detailed description
The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a three-armed randomized controlled trial of ACT treatment given as a supplement to standard treatment as either 9-session group therapy or as a 1-day workshop followed by an individual consultation, compared to standard treatment, which is one single advisory consultation.
Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study includes 180 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month |
| Workshop | Experimental | Behavioral: Acceptance and Commitment TherapyACT given as a one-day workshop with 15 patients with a following individual consultation |
| Standard treatment | Active comparator | Behavioral: Acceptance and Commitment TherapyStandard treatment is one single advisory consultation given 2 weeks after randomization |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
- Moderate or severe impact on daily life
- Symptoms lasting for at least 2 years
- Age 20-50 years
- Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
Key exclusion criteria (5 listed)
- Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
- Patients with treatment demanding psychiatric disease as dominating problem
- A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- Abuse of alcohol, narcotics or drugs
- Pregnancy at time of inclusion
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 |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals | Behavioural | Group Therapy, Standard treatment, Workshop |
Primary outcome
Global Clinical Improvement Scale
Time frame: 14 month after randomization
Questionnaire, patient-rated improvement of health since the beginning of the study.
4 secondary outcomes
SF-36
Time frame: Before randomization, and at 6, 14 and 20 months after randomization
Visual Analogue Scale for pain and worst symptom
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
Symptom Checklist (SCL)
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
WHODAS II
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
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 9 May 2017.
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.
Johanne L Agger, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Somatisation Disorder and Somatoform Disorders, run by University of Aarhus at 1 site in Denmark.
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 5 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 9 May 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 Denmark. 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?
Global Clinical Improvement Scale (time frame: 14 month after randomization). 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 9 May 2017.