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

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

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:

  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

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:
  • Cognitive behavior therapy; cognitive behaviour therapy.
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:
  • Mindfulness-based interventions

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
Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up
pre-treatment, post-treatment, 6 and 12 months follow-up
Hamilton Rating Scale for Depression
Time Frame: pre-treatment, post-treatment
Change from pre-treatment to post-treatment.
pre-treatment, post-treatment

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.
Acceptance and Action 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.
Dysfunctional Attitude Scale-revised
Time Frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up
Change between sessions to follow-up.
Pre-treatment, in-treatment, and 6 and 12 months follow-up
Working Alliance Inventory
Time Frame: 3. session
3. session
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.
Pre-, post-treatment, 6 and 12 months follow-up
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
Implicit Attitude Test
Time Frame: Pre- and posttreatment
Change pre-treatment to post-treatment
Pre- and posttreatment
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.
Pre-treatment and post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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