The present study aims to examine if BA has a positive effect on the severity of depressive symptoms as measured by the PHQ-9 in adolescent depressive participants. In addition, several additional objectives are included (classification of the…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The PHQ-9 is a 10-item self-report instrument assessing depressive symptoms
over the past 2 weeks. The internal reliability is excellent (Cronbach*s alpha
0.89), as is the test-retest reliability. In adolescents the PHQ-9 has a high
sensitivity (89,5%) and good specificity (78,8%) for detecting major depression
(Richardson et al., 2010). In this study we use the PHQ-9 weekly in line with
previous research that has shown that the PHQ-9 can be used as a reliable
indicator for weekly mood changes as well(Aguilera, Schueller & Leykin, 2015).
It can be administered in a few minutes (Kroenke, Spitzer & Williams, 2001).
Secondary outcome
- Before including the participant in the study the M.I.N.I. KID will be
administered to classify the existence of a depressive disorder. The M.I.N.I.
KID is a diagnostic interview that assesses current psychological disorders,
based on DSM-IV diagnostic criteria. The sensitivity and specificity are good
to excellent (Sheehan et al., 2010). This semi-structured interview take 60
minutes to complete in total and a maximum of 15 minutes for the section
depression.
- General functioning will be measured by the SDQ (Goodman, 1997; Dutch
version: van Widenfelt, Goedhart, Treffers, Goodman, 2003): a brief behavioral
screening questionnaire. The SDQ consists of 25 items on psychological
attributes which are divided between 5 scales: emotional symptoms, conduct
problems, hyperactivity/inattention, peer relationship problems and prosocial
behavior. The internal consistency for the various SDQ scales were generally
satisfactory (mean alpha was 0.70 for the parent version and 0.64 for the
self-report version). Furthermore, substantial correlations were found between
SDQ total difficulties scores and CBCL total scores (r = 0.70; Muris, Meesters,
& van den Berg, 2003). Completing the questionnaire takes a maximum of 20
minutes.
- The severity of general anxiety will be measured by the SCARED (Birmaher et
al. 1997; Dutch version: Wijsbroek, Hale, Raaijmakers & Muris; 2005): a
self-report instrument consisting of 69 items The items measures the symptoms
of the most important anxiety disorders. The internal consistency is 0.93
(Birmaher et al., 1997).Completion of the questionnaire takes a maximum of 20
minutes.
Background summary
The worldwide prevalence of unipolar depression is 4-5% among adolescents, with
severe implications both in the short term and the long term.
Several therapies have been developed and studied for the treatment of
depression. These therapies vary in theoretical background, duration and
intensity. With respect to psychotherapy for depression, cognitive behavioral
therapy and interpersonal therapy have the most empirical support. The specific
effective elements of these recommended treatments for depression are however
still unknown.
One of the elements which is used during cognitive behavioral therapy is
behavioral activation (BA). A meta-analysis by Weisz et al (2006) on the
effectiveness of psychotherapy with adolescents has shown that therapies with a
focus on behavior-inducing strategies have as much effect as cognitive
treatments. Several studies have been conducted to investigate the
effectiveness of protocols based on BA with promising results for improving
depressive symptoms.
However, more research is required to determine if activation as a stand-alone
treatment is sufficient to improve the depressive symptoms. Currently there is
no protocol available in the Netherlands for depressed adolescents, which uses
behavioral activation as a stand alone treatment. This study will be the first
to use and investigate the effects of behavioral activation in the treatment of
depressed adolescents in the Netherlands.
Study objective
The present study aims to examine if BA has a positive effect on the severity
of depressive symptoms as measured by the PHQ-9 in adolescent depressive
participants.
In addition, several additional objectives are included (classification of the
depressive disorder, general wellbeing and anxiety).
Study design
This study aims to include 10 participants, aged between 12 and 17 after
pre-assessment and after signing an informed consent. Participants will be
randomly assigned to a baseline phase (varying between 2-6 weeks), followed by
a treatment phase (8 weeks) and a post-treatment phase (varying between 6-10
weeks). During these 20 weeks in total, there will be a weekly assessment
measuring depressive symptoms (primary outcome). In addition to this primary
outcome, there are also 3 single time points (before treatment phase, after
treatment phase and follow up after 12 weeks) that consists of a
clinican-administred interview and self-report measures. All treatments and
assessments will be conducted in Dutch.
Intervention
This study uses a specific adapted protocol, based on a protocol which was
developed for adults and designed by Martell et al. (2013). The original
protocol aims to increase activation levels by helping adults engage in
rewarding activities and to break patterns of avoidance and withdrawal that
diminish distress in the short term but have adverse consequences in the long
term. For this study we received permission of the researchers to use and alter
the protocol which was developed for adults to use for adolescents. To alter
the protocol in order to use it more specifically for adolescents we
incorporated the recommendations of earlier studies on behavioral activation
with adolescents. The protocol consists of 8 sessions, with a duration of 45
minutes per session (total of 360 minutes).
Study burden and risks
- Benefits:
The burden on the participants is minimal. In BA participants are encouraged to
increase their activity levels, engage in more reinforcing and pleasurable
activities, and modify avoidance and withdrawal patterns, based on their own
functional analyses. This means that only behavior that is functional or
potentially pleasant for the patient will be stimulated. In this study the
timespan of the assessment is limited as much as possible, the maximum time for
an assessment is 60 minutes. The participants are not withheld treatment. In
case the treatment proves not to be successful (the depressive symptoms have
not improved after treatment) participants are offered to receive further
treatment within ProPersona Youth within a maximum of two weeks after the final
treatment session.
- Risks:
The risk of participation in this study can be considered negligible.
Betuwe Singel 1
Lienden 4033KM
NL
Betuwe Singel 1
Lienden 4033KM
NL
Listed location countries
Age
Inclusion criteria
- Current DSM-5 diagnoses of a depressive disorder (major depressive disorder, major depressive episode, persistent depressive disorder, other specified depressive disorder and unspecified depressive disorder)
- Age between 12 and 17 years
Exclusion criteria
- Acute suicidality
- Psychosis or deliusion disorders (current or in the past)
- Manic or hypomanic episodes (current or in the past)
- Mental retardation
- Substance abuse or dependence or alcohol abuse or dependence
- Insufficient ability to speak, read and write Dutch
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 | NL65442.091.18 |