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

This study is currently recruiting participants.
Verified December 2012 by VU University of Amsterdam
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01517503
First received: November 8, 2011
Last updated: December 2, 2012
Last verified: December 2012
  Purpose

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 Intervention
Major Depressive Disorder
Behavioral: Cognitive Therapy
Behavioral: Acceptance and Commitment Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR) [ Time Frame: pre-treatment, post-treatment, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up

  • Hamilton Rating Scale for Depression [ Time Frame: pre-treatment, post-treatment ] [ Designated as safety issue: No ]
    Change from pre-treatment to post-treatment.


Secondary Outcome Measures:
  • Decentering subscale of the Experiences Questionnaire [ Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up. ] [ Designated as safety issue: No ]
    Change between sessions and to follow-up.

  • Acceptance and Action Questionnaire [ Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up. ] [ Designated as safety issue: No ]
    Change between sessions and to follow-up.

  • Dysfunctional Attitude Scale-revised [ Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Change between sessions to follow-up.

  • Working Alliance Inventory [ Time Frame: 3. session ] [ Designated as safety issue: No ]
  • Eurohis Quality of Life Scale [ Time Frame: Pre-, post-treatment, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    Change pre-treatment to post-treatment and to follow-up.

  • Relationship Scales [ Time Frame: Pre-, post-treatment, 12 months follow-up ] [ Designated as safety issue: No ]
    Change pre-treatment to post-treatment and to follow-up.

  • Implicit Attitude Test [ Time Frame: Pre- and posttreatment ] [ Designated as safety issue: No ]
    Change pre-treatment to post-treatment

  • Structured Clinical Interview for DSM-IV (Major Depression Module) [ Time Frame: Pre-treatment and post-treatment. ] [ Designated as safety issue: No ]
    Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.


Estimated Enrollment: 98
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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-minute sessions will be provided over 16 weeks, with sessions generally held twice weekly for the first 6 weeks and once weekly for the next 8 weeks.
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-minute sessions will be provided over 16 weeks, with sessions generally held twice weekly for the first 6 weeks and once weekly for the next 8 weeks.
Other Name: Mindfulness-based interventions

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517503

Contacts
Contact: Nexhmedin Morina, PhD 0031-20-5258607 n.morina@uva.nl

Locations
Netherlands
PsyQ Recruiting
Zaandam, Netherlands, 1500 AE
Contact: Jacqueline A-Tjak    0031-75-6559055    J.A-Tjak@psyq.nl   
Sub-Investigator: Jacqueline A-Tjak         
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Paul MG Emmelkamp, PhD University of Amsterdam, The Netherlands
Study Director: Nexhmedin Morina, PhD University of Amsterdam, The Netherlands
  More Information

No publications provided

Responsible Party: Paul M.G.Emmelkamp, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01517503     History of Changes
Other Study ID Numbers: METC 10/103
Study First Received: November 8, 2011
Last Updated: December 2, 2012
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014