SchizophreniaSTEMNCT01655368
Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
A study testing psychotherapeutic STEM modules in people with Schizophrenia and Depression, run by Wolfgang Gaebel, Professor at 20 sites in Germany.
Trial summary
This multi-center, 2-arm interventional study within different mental health care settings (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation) evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment using a psychotherapeutic module embedded in a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Depression
- What is being tested?
- psychotherapeutic STEM modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 20 sitesGermany
- Study dates
- May 2012to Jun 2015
- 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 years
- ICD-10 diagnosis of F2, F31.3-31.5, F32-34, F34.2, F43.2
- patients who would participate in a psychoeducational group therapy in their regular treatment
- written informed consent of the patient willing to participate
- capacity of giving consent (as diagnosed by the investigator)
Who cannot join
- insufficient knowledge of german language (reading, understanding and speaking not sufficient, as judged by the investigator)
- acute psychotic or dissociative condition
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
Klinik für Psychiatrie und Psychotherapie der RWTH
Aachen, 52074
Facharztpraxis Dr. Mönter
Berlin, 10589
Facharztpraxis Gereke
Berlin, 10589
Facharztpraxis Alicia Navarro Urena
Berlin, 12203
MediClin Bliestal Kliniken, Fachklinik für psychosomatische Medizin
Blieskastel, 66440
Mittelrhein-Klinik Bad Salzig der DRV
Boppard-Bad Salzig, 56154
Klinik für Psychiatrie und Psychotherapie, Universität zu Köln
Cologne, 50937
Facharztpraxis, Dr. Frosch
Düsseldorf, 40211
Facharztpraxis Dr. Kuhlbusch
Düsseldorf, 40227
LVR-Klinikum Düsseldorf - Kliniken der Heinrich-Heine Universität
Düsseldorf, 40629
Klinik für Psychiatrie und Psychotherapie, Uniklinik Göttingen
Göttingen, 37075
Klinik für Psychiatrie und Psychotherapie, UKE
Hamburg, 20246
Oberhavel Kliniken Hennigsdorf
Hennigsdorf, 16761
Berolina Klinik
Löhne, 32584
Klinik für Psychiatrie und Psychotherapie der Uniklinik Marburg
Marburg, 35039
Klinik für Psychiatrie und Psychotherapie, LMU
Munich, 80336
Reha-Zentrum Seehof der DRV
Teltow, 14513
Psychiatrisch-psychotherapeutisches Rehabilitationszentrum grund.stein
Tübingen, 72072
Klinik für Psychiatrie und Psychotherapie
Tübingen, 72076
AHG Klinik Waren
Waren, 17192
About this study
This multi-center, 2-arm interventional study within different mental health care settings (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation) evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment using a psychotherapeutic module embedded in a psychoeducational group therapy.
Read the detailed description
People with mental illness suffer both from the burden of disease itself and from the social stigma related to mental illness, hence impeding their treatment (Sartorius et al. 2005, Link et al. 1999). Negative attitudes towards and discriminating behavior against people with mental illness negatively affect health care utilization, the course of disease, compliance, self-esteem, and social functioning (Sirey et al. 2001, Link et al. 2001, Perlick et al. 2001). Internalizing negative social stereotypes (self-stigmatization; Ritsher et al. 2003, Watson et al. 2007) impairs the quality of life and leads to social withdrawal (Rüesch 2005). Furthermore, self stigma is associated with lower empowerment (Ritsher et al. 2004), a poorer social network (Lysaker et al. 2007), lower compliance (Fung et al. 2008) and a higher extent of symptoms (Corrigan et al. 2006). The stigma of mental illness leads to an impaired pursuance of individual life goals, as job-related ambitions or living in a relationship (Rüesch 2005).
Current approaches targeting the stigma of mental illness primarily focus on education about mental illness in different target groups (e.g. Gaebel et al. 2003, 2004) and can be successful, if appropriately implemented (Gaebel et al. 2008). Yet there is a lack of RCT-tested psychotherapeutic approaches which directly address patients with mental illness improving their skills of coping with stigma and discrimination. Therefore it is intended to develop, manualise, and to evaluate such a psychotherapeutic group intervention within a randomized clinical control group design.
In this context, group-based cognitive-behavioral psychotherapy has been proved as efficient therapeutic approach for patients with depression (cf. McDermut et al. 2006) and with schizophrenia (cf. Lawrence et al. 2006, Barrowclough et al. 2006) in different settings. Patients can serve each other as role models and will modify negative self-related cognitions, thus developing new cognitions supporting self-esteem (Corrigan et al. 2001). The following interventional effects should improve the patients' quality of life and also result in a reduction of frequency and length of inpatient stays and sickness-related absenteeism:
- improved skills to cope with negative stigmatizing experiences,
- a reduced burden through of self-stigmatizing cognitions,
- a better utilization of resources for disease managing in coherence with reduced self-stigmatization, and
- an improved coping with stigma-related conflicts at work.
- Conditions
- Schizophrenia, Depression
- Being tested
- psychotherapeutic STEM modules, Interventional control of normal psychoeducational treatment
- Medical subject headings
- Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapeutic STEM modulesBehavioural
psychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression)
Interventional control of normal psychoeducational treatmentBehavioural
11 sessions + 1 booster session of psychoeducation (for schizophrenia or depression)
| Study group | Role | What they receive |
|---|---|---|
| Interventional: STEM modules | Experimental | 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression) Receives: Behavioral: psychotherapeutic STEM modules |
| Interventional Control | Other | 11 sessions + 1 booster session of psychoeducation for schizophrenia or depression) Receives: Behavioral: Interventional control of normal psychoeducational treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective quality of life
subjective quality of life 12 months after intervention determined by WHOQOL-BREF total score.
To impart coping-strategies in handling stigmatization and to develop empowerment by embedding a psychotherapeutic module in psychoeducational groups.
Measured: 12 months after intervention
Secondary outcomes (3)
self-stigma (ISMI)
Measured: after 6 weeks, 6 months, 12 months
empowerment (BUES)
Measured: after 6 weeks, 6 months, 12 months
health care utilization (CSSRI, EQ5-D, SF-36)
Measured: after 6 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfgang Gaebel, Professor
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor-investigator, Wolfgang Gaebel, Professor, Heinrich-Heine University, Duesseldorf
- Investigators
- Wolfgang Gaebel, Prof. Dr., Principal investigator, LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655368
- Sponsor's protocol ID
- STEM
- Acronym
- STEM
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2012
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Barrowclough C, Haddock G, Lobban F, Jones S, Siddle R, Roberts C, Gregg L. Group cognitive-behavioural therapy for schizophrenia. Randomised controlled trial. Br J Psychiatry. 2006 Dec;189:527-32. doi: 10.1192/bjp.bp.106.021386.
PubMed 17139037Corrigan P, Lundin R. Don´t call me nuts: Coping with the stigma of mental illness. Recovery Press, Chicago 2001
Corrigan PW, Watson AC, Barr L (2006) The Self-Stigma of Mental Illness: Implications for Self-Esteem and Self-Efficacy. J Soc Clin Psychol 25: 875-884
Gaebel W, Baumann AE. Interventions to reduce the stigma associated with severe mental illness: experiences from the open the doors program in Germany. Can J Psychiatry. 2003 Nov;48(10):657-62. doi: 10.1177/070674370304801003.
PubMed 14674047Gaebel W, Zäske H, Baumann A (2004) Stigma erschwert Behandlung und Integration. Dtsch Ärztebl 101: A3253-3255
Gaebel W, Zaske H, Baumann AE, Klosterkotter J, Maier W, Decker P, Moller HJ. Evaluation of the German WPA "program against stigma and discrimination because of schizophrenia--Open the Doors": results from representative telephone surveys before and after three years of antistigma interventions. Schizophr Res. 2008 Jan;98(1-3):184-93. doi: 10.1016/j.schres.2007.09.013. Epub 2007 Oct 24.
PubMed 17961985Lawrence R, Bradshaw T, Mairs H. Group cognitive behavioural therapy for schizophrenia: a systematic review of the literature. J Psychiatr Ment Health Nurs. 2006 Dec;13(6):673-81. doi: 10.1111/j.1365-2850.2006.01014.x.
PubMed 17087669Link BG, Phelan JC. Labeling and stigma. In: The Handbook of the Sociology of Mental Health, Hrsg. CS Aneshensel, JC Phelan. Plenum, New York 1999
Link BG, Struening EL, Neese-Todd S, Asmussen S, Phelan JC. Stigma as a barrier to recovery: The consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv. 2001 Dec;52(12):1621-6. doi: 10.1176/appi.ps.52.12.1621.
PubMed 11726753Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. doi: 10.1093/schbul/sbl016. Epub 2006 Aug 7.
PubMed 16894025McDermut W, Miller IW, Brown RA (2006) The Efficacy of Group Psychotherapy for Depression: A Meta-analysis and Review of the Empirical Research. Clinical Psychol: Science and Practice 8: 98-116
Perlick DA, Rosenheck RA, Clarkin JF, Sirey JA, Salahi J, Struening EL, Link BG. Stigma as a barrier to recovery: Adverse effects of perceived stigma on social adaptation of persons diagnosed with bipolar affective disorder. Psychiatr Serv. 2001 Dec;52(12):1627-32. doi: 10.1176/appi.ps.52.12.1627.
PubMed 11726754Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008.
PubMed 14572622Ritsher JB, Phelan JC. Internalized stigma predicts erosion of morale among psychiatric outpatients. Psychiatry Res. 2004 Dec 30;129(3):257-65. doi: 10.1016/j.psychres.2004.08.003.
PubMed 15661319Rusch N, Corrigan PW, Wassel A, Michaels P, Larson JE, Olschewski M, Wilkniss S, Batia K. Self-stigma, group identification, perceived legitimacy of discrimination and mental health service use. Br J Psychiatry. 2009 Dec;195(6):551-2. doi: 10.1192/bjp.bp.109.067157.
PubMed 19949209
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Intervention for Improving Stigma Coping and Empowerment of People With Mental Illness (STEM)
- ClinicalTrials.gov ID
- NCT01655368
- Acronym / sponsor ID
- STEM / STEM
- Conditions
- Schizophrenia, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Wolfgang Gaebel, ProfessorUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- May 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Aug 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.
This multi-center, 2-arm interventional study within different mental health care settings (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation) evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment using a psychotherapeutic module embedded in a psychoeducational group therapy.
Detailed description
People with mental illness suffer both from the burden of disease itself and from the social stigma related to mental illness, hence impeding their treatment (Sartorius et al. 2005, Link et al. 1999). Negative attitudes towards and discriminating behavior against people with mental illness negatively affect health care utilization, the course of disease, compliance, self-esteem, and social functioning (Sirey et al. 2001, Link et al. 2001, Perlick et al. 2001). Internalizing negative social stereotypes (self-stigmatization; Ritsher et al. 2003, Watson et al. 2007) impairs the quality of life and leads to social withdrawal (Rüesch 2005). Furthermore, self stigma is associated with lower empowerment (Ritsher et al. 2004), a poorer social network (Lysaker et al. 2007), lower compliance (Fung et al. 2008) and a higher extent of symptoms (Corrigan et al. 2006). The stigma of mental illness leads to an impaired pursuance of individual life goals, as job-related ambitions or living in a relationship (Rüesch 2005).
Current approaches targeting the stigma of mental illness primarily focus on education about mental illness in different target groups (e.g. Gaebel et al. 2003, 2004) and can be successful, if appropriately implemented (Gaebel et al. 2008). Yet there is a lack of RCT-tested psychotherapeutic approaches which directly address patients with mental illness improving their skills of coping with stigma and discrimination. Therefore it is intended to develop, manualise, and to evaluate such a psychotherapeutic group intervention within a randomized clinical control group design.
In this context, group-based cognitive-behavioral psychotherapy has been proved as efficient therapeutic approach for patients with depression (cf. McDermut et al. 2006) and with schizophrenia (cf. Lawrence et al. 2006, Barrowclough et al. 2006) in different settings. Patients can serve each other as role models and will modify negative self-related cognitions, thus developing new cognitions supporting self-esteem (Corrigan et al. 2001). The following interventional effects should improve the patients' quality of life and also result in a reduction of frequency and length of inpatient stays and sickness-related absenteeism:
- improved skills to cope with negative stigmatizing experiences,
- a reduced burden through of self-stigmatizing cognitions,
- a better utilization of resources for disease managing in coherence with reduced self-stigmatization, and
- an improved coping with stigma-related conflicts at work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional: STEM modules | Experimental | Behavioral: psychotherapeutic STEM modules8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module (for schizophrenia or depression) |
| Interventional Control | Other | Behavioral: Interventional control of normal psychoeducational treatment11 sessions + 1 booster session of psychoeducation for schizophrenia or depression) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 65 years
- ICD-10 diagnosis of F2, F31.3-31.5, F32-34, F34.2, F43.2
- patients who would participate in a psychoeducational group therapy in their regular treatment
- written informed consent of the patient willing to participate
- capacity of giving consent (as diagnosed by the investigator)
Key exclusion criteria (2 listed)
- insufficient knowledge of german language (reading, understanding and speaking not sufficient, as judged by the investigator)
- acute psychotic or dissociative condition
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 |
|---|---|---|
| psychotherapeutic STEM modulespsychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression) | Behavioural | Interventional: STEM modules |
| Interventional control of normal psychoeducational treatment11 sessions + 1 booster session of psychoeducation (for schizophrenia or depression) | Behavioural | Interventional Control |
Primary outcome
subjective quality of life
Time frame: 12 months after intervention
subjective quality of life 12 months after intervention determined by WHOQOL-BREF total score. To impart coping-strategies in handling stigmatization and to develop empowerment by embedding a psychotherapeutic module in psychoeducational groups.
3 secondary outcomes
self-stigma (ISMI)
Time frame: after 6 weeks, 6 months, 12 months
empowerment (BUES)
Time frame: after 6 weeks, 6 months, 12 months
health care utilization (CSSRI, EQ5-D, SF-36)
Time frame: after 6 weeks, 6 months, 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 15 Jun 2016.
- Background: PubMed 17139037Barrowclough C, Haddock G, Lobban F, Jones S, Siddle R, Roberts C, Gregg L. Group cognitive-behavioural therapy for schizophrenia. Randomised controlled trial. Br J Psychiatry. 2006 Dec;189:527-32. doi: 10.1192/bjp.bp.106.021386.
- BackgroundCorrigan P, Lundin R. Don´t call me nuts: Coping with the stigma of mental illness. Recovery Press, Chicago 2001
- BackgroundCorrigan PW, Watson AC, Barr L (2006) The Self-Stigma of Mental Illness: Implications for Self-Esteem and Self-Efficacy. J Soc Clin Psychol 25: 875-884
- Background: PubMed 14674047Gaebel W, Baumann AE. Interventions to reduce the stigma associated with severe mental illness: experiences from the open the doors program in Germany. Can J Psychiatry. 2003 Nov;48(10):657-62. doi: 10.1177/070674370304801003.
- BackgroundGaebel W, Zäske H, Baumann A (2004) Stigma erschwert Behandlung und Integration. Dtsch Ärztebl 101: A3253-3255
- Background: PubMed 17961985Gaebel W, Zaske H, Baumann AE, Klosterkotter J, Maier W, Decker P, Moller HJ. Evaluation of the German WPA "program against stigma and discrimination because of schizophrenia--Open the Doors": results from representative telephone surveys before and after three years of antistigma interventions. Schizophr Res. 2008 Jan;98(1-3):184-93. doi: 10.1016/j.schres.2007.09.013. Epub 2007 Oct 24.
- Background: PubMed 17087669Lawrence R, Bradshaw T, Mairs H. Group cognitive behavioural therapy for schizophrenia: a systematic review of the literature. J Psychiatr Ment Health Nurs. 2006 Dec;13(6):673-81. doi: 10.1111/j.1365-2850.2006.01014.x.
- BackgroundLink BG, Phelan JC. Labeling and stigma. In: The Handbook of the Sociology of Mental Health, Hrsg. CS Aneshensel, JC Phelan. Plenum, New York 1999
- Background: PubMed 11726753Link BG, Struening EL, Neese-Todd S, Asmussen S, Phelan JC. Stigma as a barrier to recovery: The consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv. 2001 Dec;52(12):1621-6. doi: 10.1176/appi.ps.52.12.1621.
- Background: PubMed 16894025Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. doi: 10.1093/schbul/sbl016. Epub 2006 Aug 7.
- BackgroundMcDermut W, Miller IW, Brown RA (2006) The Efficacy of Group Psychotherapy for Depression: A Meta-analysis and Review of the Empirical Research. Clinical Psychol: Science and Practice 8: 98-116
- Background: PubMed 11726754Perlick DA, Rosenheck RA, Clarkin JF, Sirey JA, Salahi J, Struening EL, Link BG. Stigma as a barrier to recovery: Adverse effects of perceived stigma on social adaptation of persons diagnosed with bipolar affective disorder. Psychiatr Serv. 2001 Dec;52(12):1627-32. doi: 10.1176/appi.ps.52.12.1627.
- homepage of the responsible partyLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Wolfgang Gaebel, Prof. Dr. principal investigator
LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapeutic STEM modules in people with Schizophrenia and Depression, run by Wolfgang Gaebel, Professor at 20 sites in Germany.
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 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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. 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?
subjective quality of life (time frame: 12 months after intervention). 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 NCT01655368, which also lists 20 linked publications.
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 15 Jun 2016.