The effectiveness of psychotherapy can be improved by increasing the frequency of sessions at the beginning of therapy. In addition, understanding processes that account for therapeutic change might enable us to optimize treatments.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression (BDI-II) and quality of life (EQ-5D (5L)) will be the main outcome
measures over the course of two years. Besides the completion of a clinical
interview at baseline, patients will complete monthly assessments during the
first six months of the study. There will be follow-up assessments 9, 12 and
24 months after start of treatment. For the patients who are willing to
participate, blood samples will be collected during baseline and end of
treatment.
Secondary outcome
The following secondary study parameters will be involved in the study:
Therapeutic alliance (Working Alliance Inventory), cognitive skills
(Competencies of Cognitive Therapy Scale/Performance of CT Strategies ),
interpersonal skills, recall (patients recall of the last session rated by the
therapist), motivation for therapy (Autonomous and Controlled Motivation for
Treatment Questionnaire), compliance (amount of no-show and rated by patient
and therapist), emotion regulation (Action Control Scale), executive
functioning (n-back task), automatic thoughts (Cognition Checklist ),
behavioral activation (Behavioral Activation for Depression Scale) and
biological factors (brain-derived neurotrophic factor (BDNF), DNA methylation
of CpG islands adjacent to promoters I and IV) and oxytocin.
Background summary
Recently, a strong association was found between the number of psychotherapy
sessions per week and treatment outcome. However, there is no clarity about the
optimal session frequency neither about the change mechanisms in the effects of
psychotherapy. Finding an effect for session frequency will lead to higher
therapy efficacy and lower the economic burden for depression while
understanding the processes that account for therapeutic change might make us
better able to optimize treatments.
Study objective
The effectiveness of psychotherapy can be improved by increasing the frequency
of sessions at the beginning of therapy. In addition, understanding processes
that account for therapeutic change might enable us to optimize treatments.
Study design
Multicenter randomized trial with four parallel groups (n=230) : a)
twice-weekly sessions at the start of CT, b) twice-weekly sessions at the start
of IPT, c) once-weekly sessions at the start of CT, d) once-weekly sessions at
the start of IPT. Randomization (patient level) will be pre-stratified
according to severity (high severity = BDI score =>30; low severity = BDI score
<=29).
Intervention
Twice-weekly sessions of cognitive therapy or interpersonal therapy at the
start of therapy, up to 20 sessions in total. Standard intervention to be
compared to: once-weekly sessions of cognitive therapy or interpersonal therapy
at the start of therapy, up to 20 sessions in total.
Study burden and risks
Patients will be invited to a clinical screening interview. Other measurements
will be administered online, which guarantees maximum flexibility for the
participant. Participation to the venipuncture will be an optional part of the
study. Though the burden includes a time investment of the patient, no risks
are associated with participation in the study.
van der Boechorststraat 1
Amsterdam 1081 BT
NL
van der Boechorststraat 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
a. DSM diagnosis of major depression
b. Eligible patients who are on antidepressants and who are willing to discontinue their medications during treatment, prior to participation, will be eligible to participate in the study. Patients already on antidepressants who wish to continue medication are also eligible, but only if their medication use is stable for at least three months before start of treatment
Exclusion criteria
a. severe mental illness (e.g. schizophrenia)
b. high risk for suicide
c. drug and/or alcohol dependence
d. a primary diagnosis other than MDD
e. a cluster A or B personality disorder diagnosis
f. prior psychotherapy in the previous year
g. no access to internet facilities
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 | NL49657.029.14 |