The main aim is to investigate efficacy of the Therap-i module, in addition to treatment-as-usual (TAU), in decreasing depressive symptoms in patients with MDD, who are unresponsive to protocolized psychological treatment for depression.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures to determine efficacy of the intervention will be
the change in depressive symptom severity, as measured by the Inventory of
Depressive Symptomatology self-report (IDS-SR).
Secondary outcome
Secondary outcome measures to determine efficacy of the Therap-i module are
changes in i) psychological functioning as measured by the Outcome
Questionnaire (OQ-45), ii) illness perception as measured by the Illness
Perception Questionnaire Mental Health (IPQ-MH), iii) therapeutic alliance as
measured by the Work Alliance Inventory (WAI). A descriptive outcome measure to
determine efficacy of the Therap-i module are differences between the treatment
arms in self-management as measured by the Questionnaire Self-Management in
Recovery from Depression (Vragenlijst zelfmanagement bij herstel van depressie;
QSRD).
Background summary
Major depressive disorder (MDD) is a disabling condition with debilitating
consequences for those who suffer from it and their relatives. Optimizing
treatments will reduce societal burden and risk for relapse, and improve an
individual*s quality of life. A pioneer Randomized Controlled Trial (RCT) has
shown that systematic intensive self-monitoring and personalized feedback on
contextualized patterns of positive affect through Ecological Momentary
Assessment (EMA) could provide an effective add-on tool to routine clinical
care. While promising, standardized EMA and feedback modules were used, focused
only on positive affect, in a relatively less affected group of patients in
secondary care. In this project, we will use a personalized EMA and feedback
module, named Therap-i, to intensively self-monitor affect and person specific
factors in daily life in patients with MDD in tertiary care. We hypothesize
that this module will contribute to decreased depressive symptoms via a more
precise descriptive diagnosis, tailored treatment and increased self-insight,
resulting in enduring increased self-management and better functional outcomes.
Objective: The main aim is to investigate efficacy of the Therap-i module, in
addition to treatment-as-usual (TAU), in decreasing depressive symptoms in
patients with MDD, who are unresponsive to protocolized psychological treatment
for depression.
Study objective
The main aim is to investigate efficacy of the Therap-i module, in addition to
treatment-as-usual (TAU), in decreasing depressive symptoms in patients with
MDD, who are unresponsive to protocolized psychological treatment for
depression.
Study design
A RCT with two treatment arms: TAU and TAU + Therap-i module. TAU consists of
policlinic psychological treatment for patients with MDD. The Therap-i module
can be added to treatment after patients have gone through a primary
psychological/psychotherapeutic intervention for depression, consisting of four
months of (cognitive) behavioural therapy, interpersonal therapy or brief
psychodynamic therapy. Randomization (allocation ratio 1:1) will be stratified
on the quantified level of treatment resistance based on the Dutch Method for
Quantification of Treatment Resistance in Depression (DM-TRD (Peeters et al.,
2016); cut off score >=11).
Intervention
In the Therap-i module patients will systematically self-monitor their affect
and person specific factors five times a day for two months with an electronic
diary. The diary items are based on patient data and case-conceptualization
(CC), and discussed by the therapist, researcher and patient to reach a
definitive selection. After 2, 4 and 8 weeks, patients will receive a
personalized feedback report, which will be discussed by the therapist,
researcher and patient.
Study burden and risks
There are no risks involved in study participation. The burden associated with
participation consists of: being formally screened for participation via
telephone (experimental group (EG) and control group (CG); on average 50
minutes); taking part in a resilience interview (EG, 45 minutes) and an
electronic-diary-creation session (EG; 45 minutes); filling in questionnaires
at baseline (EG and CG; 43 minutes); filling out an electronic diary on a
smartphone five times a day for two months during TAU (EG; 2 minutes per
measurement); wearing a motion watch for two months (EG and CG); taking part in
three feedback sessions wherein the personal feedback report will be discussed
during a regular consult (EG; 45 minutes per session); filling out
questionnaires on outcome measures 7 times (including follow-up assessments; EG
and CG; 18 minutes per measurement); filling out an evaluation questionnaire
and participating in a semi-structured interview at the end of the Therap-i
module (EG; 30 minutes; latter only until N = 20); filling out the
questionnaire on the descriptive outcome (EG and CG; 9 minutes). Benefits are
increased insight in (fluctuations in) one*s own affect and person specific
factors that may decrease depressive symptoms by increasing self-management and
improving functional outcomes.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Main diagnosis is Major Depressive Disorder (MDD) according to the DSM-V
- Age between 18-65 years
- Patients have previously received a primary protocolled psychological/psychotherapeutic intervention for depression, consisting of four months of (cognitive) behavioural therapy, interpersonal therapy or brief psychodynamic therapy, which is evaluated as not effective (enough) to repeat or continue by the clinician responsible for the patient.
- Patients start or receive policlinic psychological treatment wherein they have weekly one-on-one consults with a therapist for at least 8 weeks
Exclusion criteria
- A current diagnosis of:
* MDD with psychotic features
* bipolar disorder
* substance-related and addictive disorder
* schizophrenia spectrum and other psychotic disorder
* neurocognitive disorder
- Previous treatment with Electroconvulsive Therapy
- Visual impairments that cannot be corrected
- Insufficient mastery of the Dutch language
- Inability or unwillingness to manage a smartphone
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 |
|---|---|
| Other | 29302 Nederlands Trial Register (ingedient) |
| CCMO | NL66311.042.18 |