NCT02619916

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

November 30, 2015

Last Update Submit

May 17, 2016

Conditions

Depressive Symptoms

Keywords

CancerDepressionMBCTCBT

Outcome Measures

Primary Outcomes (1)

  • Change in severity of depressive symptoms

    Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)

    pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

Secondary Outcomes (4)

  • Change in generalized anxiety

    pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

  • Change in well-being

    pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

  • Change in fear of recurrence

    pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

  • Change in fatigue

    pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up

Study Arms (3)

MBCT

EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

CBT

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy (CBT)

TAU

NO INTERVENTION

Treatment as usual

Interventions

Mindfulness-Based Cognitive Therapy (MBCT)BEHAVIORAL

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

MBCT
Cognitive Behavioral Therapy (CBT)BEHAVIORAL

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

CBT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, Provincie Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

DepressionNeoplasms

Interventions

Mindfulness-Based Cognitive TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maya Schroevers, Dr.

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Tovote, Dr.

CONTACT

0031(0)503632955k.a.tovote@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. M. Schroevers

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

NL(1)