MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial

NCT ID: NCT02619916

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in patients after cancer

Detailed Description

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Cancer patients are prone to develop depressive symptoms, even after curative treatment. Conventional therapies such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are frequently used for reducing these depressive symptoms in patients with medical conditions. However, until now evidence from proper designed randomized controlled trials regarding the effectiveness of both interventions in cancer survivors, is lacking. Therefore, our longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in cancer survivors. In addition, potential moderators and mediators of each intervention will be explored.

Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBCT

Mindfulness-Based Cognitive Therapy

Group Type EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes

CBT

Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.

TAU

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-Based Cognitive Therapy (MBCT)

The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Completion of curative cancer treatment (for primary diagnosis of cancer or possible recurrence of cancer) at least one year ago and no longer than five years ago.
* Currently no active cancer.
* ≥ 18 at the time of diagnosis of cancer and ≤ 75 at inclusion.
* Depressive symptoms as assessed by a Patient Health Questionnaire (PHQ-9) score ≥ 10 (indicating presence of at least mild depressive symptoms).
* Being able to read, write, and speak Dutch.

Exclusion Criteria

* Severe psychiatric co-morbidity (i.e. acute suicidal ideations or behavior, recently experienced psychosis, diagnosis of schizophrenia, bipolar disorder, drug abuse or substance dependence, serious cognitive or neurological problems).
* Receiving psychological treatment for depressive symptoms, currently or less than two months prior to study participation.
* Unstable antidepressant medication regimen two months prior to inclusion of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Groningen

OTHER

Sponsor Role collaborator

Dutch Cancer Society

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Maya Schroevers

Dr. M. Schroevers

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maya Schroevers, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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UMCG

Groningen, Provincie Groningen, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Annika Tovote, Dr.

Role: CONTACT

0031(0)503632955

Facility Contacts

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Annika Tovote, Dr.

Role: primary

0031(0)503632955

Other Identifiers

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2014-214

Identifier Type: -

Identifier Source: org_study_id

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