Primary objective: To investigate the feasibility of a program for functional remediation for patients with BD-I or recurrent MDD, through • Evaluation of user experiences with the program. • Evaluation of drop-out and reasons for drop-out. •…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the feasibility of the program as defined by
the evaluations of the participants on closed and open ended questions and the
non-compliance and drop-out rate and reasons for dropout and non-compliance.
The two variants, fully offered online and blended, will be compared to each
other on these variabels. In addition the experiences with the online
application " Niet rennen maar plannen" will be evaluated through ratings on
closed questions.
Secondary outcome
The secondary study parameters will be the indication of change in subjective
cognitive complaints, functional improvement and change expressed in QALYs.
Background summary
This study is a pilot to evaluate the feasibility of a functional
rehabilitation program in a mixed group of patients with bipolar or unipolar
recurrent depression and cognitive complaints.
Although there is evidence that the cognitive deficits in the euthymic phase of
mood disorders are important predictors of enduring limitations in psychosocial
functioning (Depp et al.,2012; Baune et al., 2010, Baune & Malhi, 2015, Lam et
al., 2012, Wingo et al.,2009) there have been few studies addressing functional
remediation in this group of patients.
Study objective
Primary objective:
To investigate the feasibility of a program for functional remediation for
patients with BD-I or recurrent MDD, through
• Evaluation of user experiences with the program.
• Evaluation of drop-out and reasons for drop-out.
• Evaluation of user experiences with working with an E-health module.
• Evaluation of user experiences per diagnostic subgroup.
• Evaluation of user experiences with a complete online program versus blended
Secondary objective:
Exploration of functional improvement and subjective complaints through:
• Exploring change of psychosocial functioning, immediately after the
treatment, and at 3 months.
• Exploring change of subjective cognitive complaints, immediately after the
treatment, and at 3 months.
• Exploring change expressed in Quality-Adjusted Life Years (QALYs).
Study design
Uncontrolled clinical pilot study to investigate the feasibility of a
functional remediation program added to TAU, excluding group-treatment, in
patients with BD-I or recurrent MDD.
Intervention
The intervention consists of a functional remediation program, based on
strategies for the treatment of patients with acquired brain injury (Sohlberg
en Mateer, 2001, Wilson, 2003, Haskins, 2012). The strategies are aimed at the
neuropsychological problems associated with mood disorders as reported in the
literature: memory, speed of information processing and executive functioning.
The 12-session program consists of 6 group sessions followed by 6 individual
computer based online sessions. The program has 2 variants of which the first,
*Niet rennen maar plannen -online*, is fully offered online, by GGZ inGeest.The
group sessions will be held through a secure Google Meet application. The
second variant, *Niet rennen maar plannen*, is a blended program, with live
group sessions that will be held at GGZ NHN.The individual sessions will be
given through the same computer based application as the first, online variant.
The program will be preceded by an individual pre-treatment session in which
the results of the neuropsychological assessment will be communicated to the
patient by the researcher. Between sessions, homework assignments will be made
online.
The group based intervention consists of 6 weekly sessions of two blocks of 45
min, with a 15 min break between the blocks. During the *rst session,
neurocognitive problems associated with mood disorders, and their implications
for daily life, will be discussed in an interactive way.
The subsequent group sessions consist of specific information, homework and
practices, based on theory about the functioning of attention, processing
speed, and executive functioning. During the first computer based individual
session patients set goals. In the subsequent online sessions the patients work
weekly towards their goals using the online protocols and strategies presented
in worksheets. After each online session the patients receive feedback of the
filled out worksheets from one of the psychologists involved in the program.
Study burden and risks
The objective of the current study is to test the feasibility of a functional
remediation program, as an adjunctive intervention to treatment as usual (TAU).
The treatment may lead to an improvement in psycho-social functioning and
quality of life.
The treatment protocols have previously been used in treatment for a wide range
of patients including patients with brain injuries, bipolar disorder and
schizophrenia.Participants may benefit directly from the intervention. A
possible risk associated with participation may consist of confrontation with
own disability and that of others.
The extra burden of all participants is undergoing a structured diagnostic
interview, undergoing a neuropsychological assessment and filling out rating
scales.
Maelsonstraat 1
Hoorn 1624 NP
NL
Maelsonstraat 1
Hoorn 1624 NP
NL
Listed location countries
Age
Inclusion criteria
o Age: 18-60
o Bipolar I Disorder or recurrent Major Depression according to DSM 5 as
diagnosed by a psychiatrist and verified by MINI-Plus
o Subjective cognitive complaints
o At least moderate levels of functional impairments, Functioning Assessment
Short Test (FAST) interview > 18
o NLV (Dutch National Adult Reading Test) IQ > 85
o Informed consent signed by patient before participation
o Availability of a computer with internet and sufficient computer skills
o Being able to read and write in Dutch
o Mentally competent as documented in the formal treatment plan.
Exclusion criteria
oCurrent mania or severe depression (defined by scores > 5 on the Altman
Self-Rating Mania Rating Scale and >15 on the Quick Inventory of Depressive
Symptoms)
o Substance or alcohol abuse within the last 3 months (de*ned as more than 2
units/day for men, and more than 1 unit/day for women).
o A history of neurological disease or traumatic brain injury
o Electroconvulsive treatment (ECT) within the last 12 months
o Currently participating in a group-treatment, or planning to participate
within 3 months after the intervention.
oPrior participation in the study *A pilot study of a combined group and
individual functional remediation program for patients with bipolar I
disorder*.
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 | NL66487.029.18 |