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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01517503
Other study ID # METC 10/103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2011
Est. completion date August 2015

Study information

Verified date July 2019
Source VU University of Amsterdam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Netherlands PsyQ Zaandam

Sponsors (1)

Lead Sponsor Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR) 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
Primary Hamilton Rating Scale for Depression Change from pre-treatment to post-treatment. pre-treatment, post-treatment
Secondary Decentering subscale of the Experiences Questionnaire Change between sessions and to follow-up. Pre-treatment, in-treatment, and 6 and 12 months follow-up.
Secondary Acceptance and Action Questionnaire Change between sessions and to follow-up. Pre-treatment, in-treatment, and 6 and 12 months follow-up.
Secondary Dysfunctional Attitude Scale-revised Change between sessions to follow-up. Pre-treatment, in-treatment, and 6 and 12 months follow-up
Secondary Working Alliance Inventory 3. session
Secondary Eurohis Quality of Life Scale Change pre-treatment to post-treatment and to follow-up. Pre-, post-treatment, 6 and 12 months follow-up
Secondary Relationship Scales Change pre-treatment to post-treatment and to follow-up. Pre-, post-treatment, 12 months follow-up
Secondary Implicit Attitude Test Change pre-treatment to post-treatment Pre- and posttreatment
Secondary Structured Clinical Interview for DSM-IV (Major Depression Module) Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment. Pre-treatment and post-treatment.
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