Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05249543 |
| Other study ID # |
KI-2021-05587-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Karolinska Institutet |
| Contact |
Benjamin Bohman, PhD |
| Phone |
701713443 |
| Email |
benjamin.bohman[@]ki.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of the pilot study is to investigate the feasibility of conducting a
randomized controlled trial (RCT) comparing the effects of transdiagnostic and
diagnosis-specific cognitive-behavioral therapy (CBT) for patients with anxiety disorders in
routine psychiatric outpatient care in Stockholm, Sweden. It is hypothesized that an RCT is
feasible in terms of recruitment, retention, therapist competence and adherence to
treatments, and that the treatments are well received by participants.
Description:
Aim
The primary aim of the pilot study is to investigate the feasibility of conducting an RCT
comparing the the effects of two types of protocol-based individual CBT for patients with
anxiety disorders: transdiagnostic CBT using the unified protocol (UP) and diagnosis-specific
CBT using single disorder protocols (SDP). The aim of a future RCT is to replicate the only
equivalence RCT of the UP and SDPs for patients with anxiety disorders (Barlow et al., 2017).
Feasibility is investigated in terms of a) recruitment of participants across diagnoses, b)
retention of participants and data loss at post treatment, c) therapist competence in and
adherence to the UP and SDPs, d) treatment credibility and expectancy of improvement and
treatment satisfaction, and e) adverse effects. A secondary aim is to explore the effects of
the treatments in terms of a) clinical severity of diagnosis, b) anxiety and depressive
symptoms, and c) functional impairment and quality of life.
Design
Randomized controlled design by which the UP is compared to SDPs. Randomization of
participants is conduced using a 1:1 ratio. A sequence of random numbers are generated per
therapist by an independent assistant using an online random number service. The study is
conducted in routine psychiatric outpatient care at clinics in Stockholm, Sweden.
Participants
For inclusion and exclusion criteria, see other data elements. To investigate the feasibility
of an RCT and expecting a dropout rate of 20% consistent with prior research of CBT for
anxiety disorders, we believe that 76 participants is an appropriate number. In addition,
prior to recruitment of participants for treatment, 16 participants (four per therapist) are
recruited for assessment of therapist competence and adherence to the UP and SDPs. Therapists
are psychologists with training in SDPs. As their competence and adherence are assessed,
therapists are also participants in the study.
Assessment
Diagnostic assessment is conducted using the Mini International Neuropsychiatric Interview
(Sheehan et al., 1998). Clinical severity of diagnosis is assessed using the Clinical
Severity Rating (CSR; Brown & Barlow, 2014), which is rated 0-8 with 4 and above indicating
meeting a diagnosis. For feasibility and treatment effects measures, see other data elements.
Feasibility measures
Participant recruitment. We expect to be able to recruit at least seven participants per
month with four therapists.
Attrition. A common attrition rate in studies of CBT for anxiety disorders is 20%. I the 2017
equivalence RCT by Barlow and colleagues, 88% of participants in the UP condition and 69% of
participants in the SDP condition completed treatment (defined as attending at least 75% of
sessions). Thus, we expect an attrition rate of 20% at the most in respective treatment
condition.
Competence in and adherence to the UP and SDPs. Prior to participant recruitment, therapists
record treatment sessions on audio with participants who are not treated in the study and
these audio-recordings are coded by independent raters to assess therapist competence and
adherence to the UP and SDPs. Assessment of competence in and adherence to the UP is
conducted using the UP Adherence and Competence Scale (Boswell et al., 2013). This assessment
is included in the UP training of therapists and is conducted for all treatment modules used
with one participant exclusively recruited for training purposes. Assessment of competence in
diagnosis-specific CBT is conducted using the Cognitive Therapy Scale-Revised (Blackburn et
al., 2001), and adherence using the Adherence to Cognitive-Behavioral Therapy Scale (Bergvall
& Bohman, 2018). For diagnosis-specific CBT, estimates of competence and adherence are based
on three treatment sessions with three different participants per therapist recorded on audio
and coded by independent raters. These three participants are not treated in the study. As
for participants treated in the study, participants who are recruited only for training and
assessment purposes provide written informed consent to take part in the study.
Perceptions of the UP and SDPs and study procedures. Both patients and therapists respond to
surveys exploring the provision or receipt of the treatments. Patients also respond to
questions covering study procedures, including the assessment procedure and number of
measures at different assessment points.
Treatment credibility and expectancy of improvement is assessed at session 2 using the
Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000). Treatment satisfaction is
assessed at post treatment using the Client Satisfaction Questionnaire (Attkison &
Greenfield, 1996). Adverse effects are assessed during treatment by therapists reporting on
suicidal or other negative events, and by using the Negative Effects Questionnaire (Rozental
et al., 2019) or a similar measure at post assessment.
Treatment effects measures
A preliminary exploration of treatment effects and assessment of a purported mediator are
conducted. Primary treatment effects measure is clinical severity of diagnosis assessed using
the CSR. The CSR is used at pre treatment by the therapist conducting the assessment, and at
post treatment by an independent therapist who is blind to treatment condition.
In addition, treatment effects are explored in both conditions using self-report measures.
General symptoms of anxiety and depression are assessed at pre and post treatment, and at
each session using the Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al.,
2006) and the Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014),
respectively. These measures are used as part of the UP, and are also administered to
participants in the SDP condition.
The following diagnosis-specific self-report measures, corresponding to the principal
diagnosis, are responded to at pre and post treatment: the Panic Disorder Severity
Scale-Self-Rated (Houck et al., 2002) for panic disorder, the Obsessive Compulsive
Inventory-Revised (Foa et al., 2002) for obsessive-compulsive disorder, the Penn State Worry
Questionnaire (Meyer et al., 1990) for generalized anxiety disorder, the Liebowitz Social
Anxiety Scale-Self-Report (Fresco et al., 2001) for social anxiety, and the Posttraumatic
Stress Disorder Checklist-5 (Blevins et al., 2015) for post-traumatic stress disorder.
At pre and post treatment, functional impairment is assessed using the World Health
Organization Disability Assessment Schedule (World Health Organization, 2010), and quality of
life using the EuroQol Five Dimensional Questionnaire (EuroQol Group, 1990). In addition,
neuroticism, the purported mediator of the UP (Barlow et al., 2017; Sauer-Zavala et al.,
2020) is assessed at pre and post treatment and at each session using the neuroticism
subscale of the Eysenck Personality Questionnaire Revised - Short Form (Eysenck et al.,
1985). The purpose of assessing neuroticism is to investigate adherence to multiple
assessments, and to evaluate sensitivity to change.
Treatments
The UP is implemented using the Swedish translation of the published protocol (Barlow et al.,
2018a, 2018b), and SDPs using evidence-based protocols recommended in clinical guidelines
(e.g., prolonged exposure for post-traumatic stress disorder; Foa et al., 2007). All
treatments consist of 12-18 sessions, and the number of sessions per diagnosis are matched
for the UP and SDPs, so the treatment dose is the same across treatment conditions.
Procedure
Therapists receive training in the UP. Each therapist provides both the UP and SDPs in equal
amounts. During treatment, therapists receive supervision in both conditions. Eligible
patients are provided with oral and written study information and are invited to participate
by the therapist who conduct assessment, including a diagnostic interview. Patients who
consent to participate respond to self-report measures and are randomly allocated to receive
the UP or an SDP. Following the last session, a diagnostic interview is conducted by an
independent therapist blind to treatment condition, and participants respond to the same
self-report measures.
Data analysis
Feasibility measures are analyzed primarily using descriptive statistics. Preliminary
treatment effects measures are analyzed according to the intention-to-treat principle using
multilevel modeling. Model-based effect sizes with 95% confidence intervals are calculated
using equations suggested in Feingold (2015). In addition, based on Jacobson and Truax
(1991), reliable change and clinical significance are calculated.
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