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NCT Number: NCT01517503

Acceptance and Commitment Therapy Versus 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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PsyQ

Zaandam, 1500 AE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive therapy

Behavioral

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.

Acceptance and Commitment Therapy

Behavioral

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

Primary outcomes

  1. 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

  2. Hamilton Rating Scale for Depression

    Time frame: pre-treatment, post-treatment

    Change from pre-treatment to post-treatment.

Secondary outcomes

  1. 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.

  2. Acceptance and Action Questionnaire

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

    Change between sessions and to follow-up.

  3. Dysfunctional Attitude Scale-revised

    Time frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up

    Change between sessions to follow-up.

  4. Working Alliance Inventory

    Time frame: 3. session

  5. 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.

  6. Relationship Scales

    Time frame: Pre-, post-treatment, 12 months follow-up

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

  7. Implicit Attitude Test

    Time frame: Pre- and posttreatment

    Change pre-treatment to post-treatment

  8. 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.

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 25, 2012
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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