Major Depressive DisorderNCT01517503
Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder
A study testing Cognitive Therapy and Acceptance and Commitment Therapy in people with Major Depressive Disorder, run by VU University of Amsterdam at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cognitive Therapy and Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Cognitive Therapy, Acceptance and Commitment Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
Also called Cognitive behavior therapy; cognitive behaviour 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 TherapyBehavioural
Also called Mindfulness-based interventions
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy (CT) | Experimental | Cognitive Therapy (CT) Receives: Behavioral: Cognitive Therapy |
| Acceptance and Commitment Therapy (ACT) | Experimental | Acceptance and Commitment Therapy (ACT) Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR)
Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up
Measured: pre-treatment, post-treatment, 6 and 12 months follow-up
Hamilton Rating Scale for Depression
Change from pre-treatment to post-treatment.
Measured: pre-treatment, post-treatment
Secondary outcomes (8)
Decentering subscale of the Experiences Questionnaire
Change between sessions and to follow-up.
Measured: Pre-treatment, in-treatment, and 6 and 12 months follow-up.
Acceptance and Action Questionnaire
Change between sessions and to follow-up.
Measured: Pre-treatment, in-treatment, and 6 and 12 months follow-up.
Dysfunctional Attitude Scale-revised
Change between sessions to follow-up.
Measured: Pre-treatment, in-treatment, and 6 and 12 months follow-up
Working Alliance Inventory
Measured: 3. session
Eurohis Quality of Life Scale
Change pre-treatment to post-treatment and to follow-up.
Measured: Pre-, post-treatment, 6 and 12 months follow-up
Relationship Scales
Change pre-treatment to post-treatment and to follow-up.
Measured: Pre-, post-treatment, 12 months follow-up
Implicit Attitude Test
Change pre-treatment to post-treatment
Measured: Pre- and posttreatment
Structured Clinical Interview for DSM-IV (Major Depression Module)
Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.
Measured: Pre-treatment and post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M.G.Emmelkamp, VU University of Amsterdam
- Investigators
- Paul MG Emmelkamp, PhD, Principal investigator, University of AmsterdamNexhmedin Morina, PhD, Study director, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517503
- Sponsor's protocol ID
- METC 10/103
- Status last verified
- Jul 2019
- First submitted
- 8 Nov 2011
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33446152A-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.
PubMed 32264845
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01517503
- Acronym / sponsor ID
- METC 10/103
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy (CT) | Experimental | Behavioral: Cognitive TherapyCognitive Therapy (CT) |
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy (ACT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TherapyAlso: Cognitive behavior therapy; cognitive behaviour 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. | Behavioural | Cognitive Therapy (CT) |
| Acceptance and Commitment TherapyAlso: Mindfulness-based interventionsThis 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. | Behavioural | Acceptance and Commitment Therapy (ACT) |
Primary outcome
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
Hamilton Rating Scale for Depression
Time frame: pre-treatment, post-treatment
Change from pre-treatment to post-treatment.
8 secondary outcomes
Decentering subscale of the Experiences Questionnaire
Time frame: 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.
Dysfunctional Attitude Scale-revised
Time frame: Pre-treatment, in-treatment, and 6 and 12 months follow-up
Working Alliance Inventory
Time frame: 3. session
Eurohis Quality of Life Scale
Time frame: Pre-, post-treatment, 6 and 12 months follow-up
Relationship Scales
Time frame: Pre-, post-treatment, 12 months follow-up
Implicit Attitude Test
Time frame: Pre- and posttreatment
Structured Clinical Interview for DSM-IV (Major Depression Module)
Time frame: Pre-treatment and post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 33446152A-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.
- Derived from this study: PubMed 32264845A-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul MG Emmelkamp, PhD principal investigator
University of Amsterdam
Nexhmedin Morina, PhD study director
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy and Acceptance and Commitment Therapy in people with Major Depressive Disorder, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR) (time frame: pre-treatment, post-treatment, 6 and 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.