- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517503
Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder
July 26, 2019 updated by: Paul M.G.Emmelkamp, VU University of Amsterdam
Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder
The study will investigate the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with Major Depressive Disorder in routine clinical practice.
Furthermore, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The current study aims at investigating the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with MDD in routine clinical practice.
Further, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism.
Patients have to meet diagnostic criteria for nonpsychotic MDD as determined by the Structured Interview for DSM-IV.
Each client will receive either Cognitive Therapy or Acceptance and Commitment Therapy that will last between 16 to 20 sessions.
Based on previous results, it is expected that both treatment forms will prove beneficial for the patients.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zaandam, Netherlands, 1500 AE
- PsyQ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meeting DSM-IV criteria for MDD
- Between the ages of 18 and 65-years-old
- Having sufficient fluency in Dutch to complete treatment and research protocol
Exclusion Criteria:
- DSM-IV criteria for bipolar disorder (past or present)
- Psychotic disorders
- Substance dependence disorders (current or within the past 6 months), or
- Organic brain syndrome.
- Borderline or antisocial personality disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Therapy (CT)
|
This interventions will target: (a) behavioral dysfunction, (b) situation-specific negative thinking and cognitive distortions, and (c) underlying dysfunctional beliefs or cognitions assumed to be related to the patient's current depression and risk of future depression.
A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.
Other Names:
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Experimental: Acceptance and Commitment Therapy (ACT)
|
This interventions will use (a) acceptance, (b) commitment, (c) mindfulness, and (d) behavior change processes to produce reduction of depressive symptoms.
A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR)
Time Frame: pre-treatment, post-treatment, 6 and 12 months follow-up
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Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up
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pre-treatment, post-treatment, 6 and 12 months follow-up
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Hamilton Rating Scale for Depression
Time Frame: pre-treatment, post-treatment
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Change from pre-treatment to post-treatment.
|
pre-treatment, post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decentering subscale of the Experiences Questionnaire
Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up.
|
Change between sessions and to follow-up.
|
Pre-treatment, in-treatment, and 6 and 12 months follow-up.
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Acceptance and Action Questionnaire
Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up.
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Change between sessions and to follow-up.
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Pre-treatment, in-treatment, and 6 and 12 months follow-up.
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Dysfunctional Attitude Scale-revised
Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up
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Change between sessions to follow-up.
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Pre-treatment, in-treatment, and 6 and 12 months follow-up
|
Working Alliance Inventory
Time Frame: 3. session
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3. session
|
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Eurohis Quality of Life Scale
Time Frame: Pre-, post-treatment, 6 and 12 months follow-up
|
Change pre-treatment to post-treatment and to follow-up.
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Pre-, post-treatment, 6 and 12 months follow-up
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Relationship Scales
Time Frame: Pre-, post-treatment, 12 months follow-up
|
Change pre-treatment to post-treatment and to follow-up.
|
Pre-, post-treatment, 12 months follow-up
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Implicit Attitude Test
Time Frame: Pre- and posttreatment
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Change pre-treatment to post-treatment
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Pre- and posttreatment
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Structured Clinical Interview for DSM-IV (Major Depression Module)
Time Frame: Pre-treatment and post-treatment.
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Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.
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Pre-treatment and post-treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul MG Emmelkamp, PhD, University of Amsterdam
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- A-Tjak JGL, Morina N, Topper M, Emmelkamp PMG. One year follow-up and mediation in cognitive behavioral therapy and acceptance and commitment therapy for adult depression. BMC Psychiatry. 2021 Jan 14;21(1):41. doi: 10.1186/s12888-020-03020-1.
- A-Tjak JGL, Morina N, Boendermaker WJ, Topper M, Emmelkamp PMG. Explicit and implicit attachment and the outcomes of acceptance and commitment therapy and cognitive behavioral therapy for depression. BMC Psychiatry. 2020 Apr 7;20(1):155. doi: 10.1186/s12888-020-02547-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
November 8, 2011
First Submitted That Met QC Criteria
January 20, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Actual)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 26, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 10/103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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