Unipolar DepressionPhase 2NCT01012856
Randomized Clinical Trial of an Exposure-based Cognitive Therapy for Depression
A Phase 2 study testing Cognitive-Behavioral Therapy for Depression and Exposure-Based Cognitive Therapy for Depression in people with Unipolar Depression, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Cognitive-Behavioral Therapy for Depression and Exposure-Based Cognitive Therapy for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Mar 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Disorder according to DSM-IV as main diagnosis
- minimum standardized depression scores (BDI >= 17; HAMD >=13)
- minimum age of 18 years
- informed consent to participate voluntarily in the study
- sufficient German language skills
Who cannot join
- acute suicidality
- depressive disorder with mood-incongruent psychotic features
- chronic depressive disorder
- organic cause of depression
- drug-induced depression
- bipolar disorder
Show all 11Show fewer
- diagnosis of schizophrenia, schizophreniform, schizoaffective disorders, and/or psychosis NOS
- comorbid dysthymia, psychotic disorder (acute or anamnestic), dementia, substance dependence, schizotypal/ borderline/ or antisocial personality disorder
- psychopharmacological treatment other than antidepressants
- antidepressant medication, if it is changed within one month prior to the beginning of psychotherapy
- other simultaneous psychological treatments
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Department of Psychology
Zurich, Canton of Zurich, 8050
About this study
Official title: Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy
The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.
- Conditions
- Unipolar Depression
- Being tested
- Cognitive-Behavioral Therapy for Depression, Exposure-Based Cognitive Therapy for Depression
- Keywords
- depressive episode, psychotherapy, cognitive therapy, emotional processing, RCT, exposure, dual process model, Implicit Association Test, mechanism of change
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for DepressionBehavioural
22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions
Exposure-Based Cognitive Therapy for DepressionBehavioural
22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy for Depression (CBT) | Active comparator | Not described Receives: Behavioral: Cognitive-Behavioral Therapy for Depression |
| Exposure-Based Cognitive Therapy for Depression (EBCT) | Experimental | Not described Receives: Behavioral: Exposure-Based Cognitive Therapy for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)
Measured: end of therapy, 6 month after end of therapy (follow up)
Secondary outcomes (10)
symptom impairment measured by the Brief Symptom Inventory (BSI)
Measured: end of therapy, 6-month follow up
quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Measured: end of therapy, 6-month follow-up
interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)
Measured: end of therapy, 6-month follow-up
avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)
Measured: end of therapy, 6-month follow-up
resources measured by the Bernese Inventory of Resources (RES-K)
Measured: end of therapy, 6-month follow-up
explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)
Measured: end of therapy, 6-month follow up
implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)
Measured: end of therapy
goal attainment measured by Goal Attainment Scaling (GAS)
Measured: end of therapy
avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)
Measured: end of therpy, 6-month follow-up
motivational incongruence measured by The Incongruence Questionnaire (INC)
Measured: end of therapy, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grosse Holtforth, Professor MD, Principal investigator, University of Zurich, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012856
- Sponsor's protocol ID
- PP00P1_ 123377
- Status last verified
- Oct 2012
- First submitted
- 11 Nov 2009
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes AM, Feldman GC, Beevers CG, Laurenceau JP, Cardaciotto L, Lewis-Smith J. Discontinuities and cognitive changes in an exposure-based cognitive therapy for depression. J Consult Clin Psychol. 2007 Jun;75(3):409-421. doi: 10.1037/0022-006X.75.3.409.
PubMed 17563158Hayes AM, Strauss JL. Dynamic systems theory as a paradigm for the study of change in psychotherapy: an application to cognitive therapy for depression. J Consult Clin Psychol. 1998 Dec;66(6):939-47. doi: 10.1037//0022-006x.66.6.939.
PubMed 9874907Hayes AM, Laurenceau JP, Feldman G, Strauss JL, Cardaciotto L. Change is not always linear: the study of nonlinear and discontinuous patterns of change in psychotherapy. Clin Psychol Rev. 2007 Jul;27(6):715-23. doi: 10.1016/j.cpr.2007.01.008. Epub 2007 Jan 19.
PubMed 17316941Beevers CG. Cognitive vulnerability to depression: a dual process model. Clin Psychol Rev. 2005 Nov;25(7):975-1002. doi: 10.1016/j.cpr.2005.03.003.
PubMed 15905008Pascual-Leone A. Dynamic emotional processing in experiential therapy: two steps forward, one step back. J Consult Clin Psychol. 2009 Feb;77(1):113-26. doi: 10.1037/a0014488.
PubMed 19170458Babl A, Rubel J, Gomez Penedo JM, Berger T, Grosse Holtforth M, Eubanks CF. Can session-by-session changes in self-reported alliance scores serve as a measure of ruptures in the therapeutic alliance? J Consult Clin Psychol. 2024 Feb;92(2):129-133. doi: 10.1037/ccp0000861. Epub 2023 Nov 27.
PubMed 38010758Grosse Holtforth M, Krieger T, Zimmermann J, Altenstein-Yamanaka D, Dorig N, Meisch L, Hayes AM. A randomized-controlled trial of cognitive-behavioral therapy for depression with integrated techniques from emotion-focused and exposure therapies. Psychother Res. 2019 Jan;29(1):30-44. doi: 10.1080/10503307.2017.1397796. Epub 2017 Nov 12.
PubMed 29130400
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy
- ClinicalTrials.gov ID
- NCT01012856
- Acronym / sponsor ID
- PP00P1_ 123377
- Conditions
- Unipolar Depression
- Keywords
- depressive episode, psychotherapy, cognitive therapy, emotional processing, RCT, exposure, dual process model, Implicit Association Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 13 Nov 2009 (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 investigate, if exposure-based cognitive therapy (EBCT) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy for Depression (CBT) | Active comparator | Behavioral: Cognitive-Behavioral Therapy for Depression |
| Exposure-Based Cognitive Therapy for Depression (EBCT) | Experimental | Behavioral: Exposure-Based Cognitive Therapy for Depression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major Depressive Disorder according to DSM-IV as main diagnosis
- minimum standardized depression scores (BDI >= 17; HAMD >=13)
- minimum age of 18 years
- informed consent to participate voluntarily in the study
- sufficient German language skills
Key exclusion criteria (11 listed)
- acute suicidality
- depressive disorder with mood-incongruent psychotic features
- chronic depressive disorder
- organic cause of depression
- drug-induced depression
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 |
|---|---|---|
| Cognitive-Behavioral Therapy for Depression22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions | Behavioural | Cognitive-Behavioral Therapy for Depression (CBT) |
| Exposure-Based Cognitive Therapy for Depression22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions | Behavioural | Exposure-Based Cognitive Therapy for Depression (EBCT) |
Primary outcome
severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)
Time frame: end of therapy, 6 month after end of therapy (follow up)
10 secondary outcomes
symptom impairment measured by the Brief Symptom Inventory (BSI)
Time frame: end of therapy, 6-month follow up
quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: end of therapy, 6-month follow-up
interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)
Time frame: end of therapy, 6-month follow-up
avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)
Time frame: end of therapy, 6-month follow-up
resources measured by the Bernese Inventory of Resources (RES-K)
Time frame: end of therapy, 6-month follow-up
explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)
Time frame: end of therapy, 6-month follow up
implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)
Time frame: end of therapy
goal attainment measured by Goal Attainment Scaling (GAS)
Time frame: end of therapy
avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)
Time frame: end of therpy, 6-month follow-up
motivational incongruence measured by The Incongruence Questionnaire (INC)
Time frame: end of therapy, 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- Background: PubMed 17563158Hayes AM, Feldman GC, Beevers CG, Laurenceau JP, Cardaciotto L, Lewis-Smith J. Discontinuities and cognitive changes in an exposure-based cognitive therapy for depression. J Consult Clin Psychol. 2007 Jun;75(3):409-421. doi: 10.1037/0022-006X.75.3.409.
- Background: PubMed 9874907Hayes AM, Strauss JL. Dynamic systems theory as a paradigm for the study of change in psychotherapy: an application to cognitive therapy for depression. J Consult Clin Psychol. 1998 Dec;66(6):939-47. doi: 10.1037//0022-006x.66.6.939.
- Background: PubMed 17316941Hayes AM, Laurenceau JP, Feldman G, Strauss JL, Cardaciotto L. Change is not always linear: the study of nonlinear and discontinuous patterns of change in psychotherapy. Clin Psychol Rev. 2007 Jul;27(6):715-23. doi: 10.1016/j.cpr.2007.01.008. Epub 2007 Jan 19.
- Background: PubMed 15905008Beevers CG. Cognitive vulnerability to depression: a dual process model. Clin Psychol Rev. 2005 Nov;25(7):975-1002. doi: 10.1016/j.cpr.2005.03.003.
- Background: PubMed 19170458Pascual-Leone A. Dynamic emotional processing in experiential therapy: two steps forward, one step back. J Consult Clin Psychol. 2009 Feb;77(1):113-26. doi: 10.1037/a0014488.
- Derived from this study: PubMed 38010758Babl A, Rubel J, Gomez Penedo JM, Berger T, Grosse Holtforth M, Eubanks CF. Can session-by-session changes in self-reported alliance scores serve as a measure of ruptures in the therapeutic alliance? J Consult Clin Psychol. 2024 Feb;92(2):129-133. doi: 10.1037/ccp0000861. Epub 2023 Nov 27.
- Derived from this study: PubMed 29130400Grosse Holtforth M, Krieger T, Zimmermann J, Altenstein-Yamanaka D, Dorig N, Meisch L, Hayes AM. A randomized-controlled trial of cognitive-behavioral therapy for depression with integrated techniques from emotion-focused and exposure therapies. Psychother Res. 2019 Jan;29(1):30-44. doi: 10.1080/10503307.2017.1397796. Epub 2017 Nov 12.
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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.
Martin Grosse Holtforth, Professor MD principal investigator
University of Zurich, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive-Behavioral Therapy for Depression and Exposure-Based Cognitive Therapy for Depression in people with Unipolar Depression, run by University of Zurich at 1 site in Switzerland.
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 11 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: status not confirmed, as of the sponsor's last update on 31 Oct 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II) (time frame: end of therapy, 6 month after end of therapy (follow up)). 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 NCT01012856, which also lists 7 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 31 Oct 2012.