NCT01517503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2011

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

November 8, 2011

Last Update Submit

July 26, 2019

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • Hamilton Rating Scale for Depression

    Change from pre-treatment to post-treatment.

    pre-treatment, post-treatment

Secondary Outcomes (8)

  • Decentering subscale of the Experiences Questionnaire

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

  • Acceptance and Action Questionnaire

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

  • Dysfunctional Attitude Scale-revised

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

  • Working Alliance Inventory

    3. session

  • Eurohis Quality of Life Scale

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

  • +3 more secondary outcomes

Study Arms (2)

Cognitive Therapy (CT)

EXPERIMENTAL

Cognitive Therapy (CT)

Behavioral: Cognitive Therapy

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Behavioral: Acceptance and Commitment Therapy

Interventions

Cognitive TherapyBEHAVIORAL

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.

Also known as: Cognitive behavior therapy; cognitive behaviour therapy.
Cognitive Therapy (CT)
Acceptance and Commitment TherapyBEHAVIORAL

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.

Also known as: Mindfulness-based interventions
Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PsyQ

Zaandam, 1500 AE, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 33446152DERIVED

  • 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.

    PMID: 32264845DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral TherapyAcceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Paul MG Emmelkamp, PhD

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

  • Nexhmedin Morina, PhD

    University of Amsterdam

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2011

First Posted

January 25, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

NL(1)