We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01517503
Previous Study | Return to List | Next Study

Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01517503
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Cognitive Therapy Behavioral: Acceptance and Commitment Therapy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder
Study Start Date : December 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cognitive Therapy (CT)
Cognitive Therapy (CT)
 Behavioral: Cognitive Therapy
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 Name: Cognitive behavior therapy; cognitive behaviour therapy.
Experimental: Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy (ACT)
 Behavioral: Acceptance and Commitment Therapy
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 Name: Mindfulness-based interventions


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR) [ Time Frame: pre-treatment, post-treatment, 6 and 12 months follow-up ]
    Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up

  2. Hamilton Rating Scale for Depression [ Time Frame: pre-treatment, post-treatment ]
    Change from pre-treatment to post-treatment.


Secondary Outcome Measures :
  1. 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.

  2. Acceptance and Action Questionnaire [ Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up. ]
    Change between sessions and to follow-up.

  3. Dysfunctional Attitude Scale-revised [ Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up ]
    Change between sessions to follow-up.

  4. Working Alliance Inventory [ Time Frame: 3. session ]
  5. 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.

  6. Relationship Scales [ Time Frame: Pre-, post-treatment, 12 months follow-up ]
    Change pre-treatment to post-treatment and to follow-up.

  7. Implicit Attitude Test [ Time Frame: Pre- and posttreatment ]
    Change pre-treatment to post-treatment

  8. Structured Clinical Interview for DSM-IV (Major Depression Module) [ Time Frame: Pre-treatment and post-treatment. ]
    Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meeting DSM-IV criteria for MDD
  2. Between the ages of 18 and 65-years-old
  3. Having sufficient fluency in Dutch to complete treatment and research protocol

Exclusion Criteria:

  1. DSM-IV criteria for bipolar disorder (past or present)
  2. Psychotic disorders
  3. Substance dependence disorders (current or within the past 6 months), or
  4. Organic brain syndrome.
  5. Borderline or antisocial personality disorder
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517503


Locations
Layout table for location information
Netherlands
PsyQ
Zaandam, Netherlands, 1500 AE
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Layout table for investigator information
Principal Investigator: Paul MG Emmelkamp, PhD University of Amsterdam
Study Director: Nexhmedin Morina, PhD University of Amsterdam
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Paul M.G.Emmelkamp, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01517503    
Other Study ID Numbers: METC 10/103
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms