Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06282250 |
Other study ID # |
in progress |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2024 |
Est. completion date |
December 2025 |
Study information
Verified date |
April 2024 |
Source |
Geestelijke Gezondheidszorg Eindhoven (GGzE) |
Contact |
Else Treffers, MSc |
Phone |
+31622559192 |
Email |
else.treffers[@]ggze.nl |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In the current study, the feasibility, acceptability and effectivity of a new add-on early
intervention program for individuals at risk for the development of bipolar disorder is
evaluated. This intervention program entails psycho-education, light and lifestyle therapy in
combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to
early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm
and lifestyle factors such as activity level. We hypothesize a relationship between this
early intervention and a significant improvement in mood symptoms, anxiety, subjective and
objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and
associations with clinical improvement of symptoms will be studied.
Additionally, in a separate validation study, data will be collected to validate a new
instrument for the early detection of those at risk for bipolar disorders. The Semistructured
Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and
validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and
colleagues.
Description:
Severe mental illnesses (SMI) distinguished as bipolar disorder and psychotic spectrum
disorders, substantially impair patients' engagement in functional and occupational
activities and severely limit social and societal functioning (GGZ Standaarden, 2022; NIH,
2022; NIMH, 2018). Based on the Dutch definition of SMI 1.7% of the national population
suffers from an SMI (GGZ Standaarden, 2022). Despite this, time between first symptoms and
accurate SMI diagnosis, can add up to more than 9.5 years in the case of bipolar disorders.
For the psychotic spectrum, an early detection and intervention program (UHR) carried out by
special EDI-Teams already exists, and has been found effective in limiting the transition to
SMI with fifty percent. For bipolar disorders, no such program exists. This raises the
question whether prodromal and subclinical symptoms of this disorder can be detected earlier
and if transition into SMI can be limited. In light of current studies into the at-risk
mental state, and the current development towards a possible transdiagnostic model for early
detection and intervention of SMI (CHARMS-categories; (Liu et al., 2022)), the current study
aims to contribute to limiting the transition into bipolar disorder. As a disturbance in
circadian rhythm, as well as mood and anxiety symptoms are risk indicators for SMI in general
and bipolar in specific, the current study evaluates an early intervention program for
individuals at risk for developing an SMI, with a focus on bipolar symptomatology.
Individuals at risk will answer questions from the SIBARS interview. As explained in a
publication of Fusar-Poli et al. (2022), "The Semi-structured Interview for Bipolar At Risk
States (SIBARS) included a combination of several items adapted from well-established rating
scales: (CAARMS (Yung et al., 2005); Hypomania Checklist-32 (Angst et al., 2005); Altman
Self-Rating Mania Scale (Altman et al., 1997); TEMPS-A questionnaire (Akiskal et al., 2005);
QIDS-SR (Rush et al., 2003); Bergen Insomnia Scale (Pallesen et al., 2008); Idiopathic
hypersomnia questionnaire (Vernet et al., 2010)). The SIBARS interview was developed for
youths aged 15-35 and comprehended 5 domains: 1. Subtreshold Mania, 2. Depression, 3.
Cyclothymic Features, 4. Genetic Risk, 5. Mood Swings. Subtreshold Mania, Depression and Mood
Swings are continuous rating scales (that include a severity and frequency anchors), while
Cyclothyimc Features and Genetic Risk are categorical scales (yes/no). The cut-offs allow
assigning the specific subgroup of the BARS criteria: 1. Substreshold Mania, 2.
Depression+Cyclothymic Features, 3. Depression+Genetic Risk, 4. Cyclothymic Features+Genetic
Risk, 5.Subtreshold Mixed Episode, 6. Mood Swings."