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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Cognitive Therapy

Acceptance and Commitment Therapy

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

PsyQ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cognitive Therapy (CT)

Acceptance and Commitment Therapy (ACT)

Arm Description

Cognitive Therapy (CT)

Acceptance and Commitment Therapy (ACT)

Outcomes

Primary Outcome Measures

QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR)

Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up

Hamilton Rating Scale for Depression

Change from pre-treatment to post-treatment.

Secondary Outcome Measures

Decentering subscale of the Experiences Questionnaire

Change between sessions and to follow-up.

Acceptance and Action Questionnaire

Change between sessions and to follow-up.

Dysfunctional Attitude Scale-revised

Change between sessions to follow-up.

Working Alliance Inventory

Eurohis Quality of Life Scale

Change pre-treatment to post-treatment and to follow-up.

Relationship Scales

Change pre-treatment to post-treatment and to follow-up.

Implicit Attitude Test

Change pre-treatment to post-treatment

Structured Clinical Interview for DSM-IV (Major Depression Module)

Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.

Full Information

NCT ID

NCT01517503

First Posted

November 8, 2011

Last Updated

July 26, 2019

Sponsor

VU University of Amsterdam

1. Study Identification

Unique Protocol Identification Number

NCT01517503

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VU University of Amsterdam

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Therapy (CT)

Arm Type

Experimental

Arm Description

Cognitive Therapy (CT)

Arm Title

Acceptance and Commitment Therapy (ACT)

Arm Type

Experimental

Arm Description

Acceptance and Commitment Therapy (ACT)

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Therapy

Other Intervention Name(s)

Cognitive behavior therapy; cognitive behaviour therapy.

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Acceptance and Commitment Therapy

Other Intervention Name(s)

Mindfulness-based interventions

Intervention Description

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.

Primary Outcome Measure Information:

Title

QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR)

Description

Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up

Time Frame

pre-treatment, post-treatment, 6 and 12 months follow-up

Title

Hamilton Rating Scale for Depression

Description

Change from pre-treatment to post-treatment.

Time Frame

pre-treatment, post-treatment

Secondary Outcome Measure Information:

Title

Decentering subscale of the Experiences Questionnaire

Description

Change between sessions and to follow-up.

Time Frame

Pre-treatment, in-treatment, and 6 and 12 months follow-up.

Title

Acceptance and Action Questionnaire

Description

Change between sessions and to follow-up.

Time Frame

Pre-treatment, in-treatment, and 6 and 12 months follow-up.

Title

Dysfunctional Attitude Scale-revised

Description

Change between sessions to follow-up.

Time Frame

Pre-treatment, in-treatment, and 6 and 12 months follow-up

Title

Working Alliance Inventory

Time Frame

3. session

Title

Eurohis Quality of Life Scale

Description

Change pre-treatment to post-treatment and to follow-up.

Time Frame

Pre-, post-treatment, 6 and 12 months follow-up

Title

Relationship Scales

Description

Change pre-treatment to post-treatment and to follow-up.

Time Frame

Pre-, post-treatment, 12 months follow-up

Title

Implicit Attitude Test

Description

Change pre-treatment to post-treatment

Time Frame

Pre- and posttreatment

Title

Structured Clinical Interview for DSM-IV (Major Depression Module)

Description

Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.

Time Frame

Pre-treatment and post-treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul MG Emmelkamp, PhD

Organizational Affiliation

University of Amsterdam

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nexhmedin Morina, PhD

Organizational Affiliation

University of Amsterdam

Official's Role

Study Director

Facility Information:

Facility Name

PsyQ

City

Zaandam

ZIP/Postal Code

1500 AE

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

33446152

Citation

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.

Results Reference

derived

PubMed Identifier

32264845

Citation

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.

Results Reference

derived

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

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