Primary Objective- To assess short and long-term effects of individual Cognitive Behavioral Therapy (CBT) and individual Mindfulness-Based Cognitive Therapy (MBCT) in reducing depressive symptoms in cancer patients with clinically significant…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depressive symptom severity.
Secondary outcome
Anxiety, fear of recurrence, fatigue.
Background summary
Depression is highly prevalent in cancer patients. MBCT and CBT are
evidence-based psychological treatments for reducing depressive symptoms in the
general population, but its efficacy for patients with cancer needs more
evidence. This longitudinal study aims to investigate the effectiveness of MBCT
and CBT in reducing depressive symptoms, in cancer patients between one and
five years after completing curative cancer treatment and had no evidence of
disease recurrence at inclusion. Also patients* satisfaction with treatment
will be investigated. Furthermore, potential moderators and mediators of
intervention effects as well as cost-effectiveness will be examined.
Study objective
Primary Objective
- To assess short and long-term effects of individual Cognitive Behavioral
Therapy (CBT) and individual Mindfulness-Based Cognitive Therapy (MBCT) in
reducing depressive symptoms in cancer patients with clinically significant
depressive symptoms, compared to a treatment as usual (TAU) control condition.
We hypothesize that CBT and MBCT are more effective than the TAU condition in
reducing depressive symptoms in cancer patients.
Secondary Objectives
- To examine predictors of treatment effects of CBT and MBCT: (1) baseline
levels of depressive symptoms, (2) baseline levels of secondary outcomes, (3)
history of depression.
- To examine mediators of treatment effects of CBT and MBCT: (1) behavioral
activation, (2) repetitive negative thinking, (3) mindfulness, (4) expectations
of improvement.
- To examine patients* acceptability of CBT and MBCT.
- To examine the cost-effectiveness of CBT and MBCT.
Study design
In a randomized controlled trial, patient will be assigned to one of three
conditions: MBCT, CBT, or TAU control condition. We plan to include 64 patients
per condition (total 192 patients).
Intervention
The intervention consists of 8 weekly individual sessions of MBCT or CBT, with
each session lasting 60 minutes. For both interventions, a structured protocol
is available.
Study burden and risks
The burden for patients consists of completing a written questionnaire at five
points in time, with time costs per assessment of around 30 minutes and a
structured clinical interview at threetime points, lasting about 15 minutes
each. Furthermore, 2/3 of patients receive treatment in which techniques are
used that have proven to be effective in the treatment of depression and
prevention of recurrence of depression (time costs: 8 weekly sessions of 60
minutes each, approximately 30 minutes of daily homework). We know of no
negative effects of these treatments. Therefore, we consider the risks of this
study to be low, as patients are primarily asked to invest time and effort.
A. Deusinglaan 1
Groningen 9713 AV
NL
A. Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
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.
Age >= 18 and <= 75 years at the time of diagnosis of cancer.
Depressive symptoms as assessed by 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49111.042.14 |