Major Depressive Disorder Clinical Trial
Official title:
Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder
| 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 |
| Verified date | July 2019 |
| Source | VU University of Amsterdam |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | PsyQ | Zaandam |
| Lead Sponsor | Collaborator |
|---|---|
| VU University of Amsterdam |
Netherlands,
| 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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