Feeling Safe-Netherlands: recovery-oriented cognitive behaviour therapy to promote wellbeing and feeling safer.

Threat beliefs, also referred to as persecutory delusions or paranoia, are
strong unfounded fears that people intend to harm you. Threat beliefs are
highly prevalent and transdiagnostic experiences that are associated with the
persistence of mental health problems and long-term treatment trajectories.
Severe threat beliefs are associated with poor outcomes involving impairment in
multiple functional domains and psychological well-being in the lowest 2% of
the general population. Psychological mechanisms underlying threat belief
formation and maintenance appear consistent across diagnoses, with traumatic
stress and insomnia being two of the strongest causal factors. On the 15th of
June 2020, Zorginstituut Nederland (ZIN) sent the *Verbetersignalement
Psychose* to the State Secretary for Health, Welfare, and Sports. The most
important conclusion of this report is that only a small minority of the
patients with psychosis receive the guideline intervention cognitive behaviour
therapy for psychosis (CBTp). The report emphasises the necessity of
implementing CBTp in routine clinical practice, and to test new
(cost-)effective psychological treatments for psychosis. This is exactly the
ambition of the current research project, which is a collaboration between
scientists, clinicians, and experts by experience. We aim to reduce threat
beliefs and improve wellbeing with a recovery-oriented intervention that is
cost-effective and easy to implement. We acknowledge that
recovery involves more than the absence of mental health problems and concerns
a highly personal process of enhancing resilience. To this end, we build on the
translational Oxford Feeling Safe Programme that involves a personalised
treatment in which the causal psychological factors that drive threat beliefs
are targeted one-by-one. This is done with brief CBT modules that are selected
by patients from a personalised menu of treatment options. This will now be
tested as the Feeling Safe-NL Programme, which aims to promote wellbeing by
synergistically reducing the causal factors that hamper recovery, while
concurrently addressing personal recovery with peer-support. We will test
whether this new translational, recovery-oriented, transdiagnostic, modular,
and peer-supported treatment is more (cost-)effective in improving wellbeing
and reducing threat beliefs than CBTp.

Primary Objective:
To test whether the Feeling Safe-NL programme is more effective in improving
wellbeing over time than CBTp (from baseline to 18-month follow-up).

Secondary objectives:
To test whether the Feeling Safe-NL programme is more effective in reducing
conviction and distress of the main threat belief, general paranoid ideation,
patient chosen outcomes of therapy and activity levels over time (from baseline
to 18-month follow-up) than CBTp. We also assess outcomes at the different
time-points (6-, 12- and 18-month follow-up). Additionally, we investigate the
mediators of improved wellbeing and reduced threat beliefs and whether the
Feeling Safe-NL programme is more cost-effective than CBTp.

We will conduct a two-armed single-blind pragmatic superiority randomised
controlled trial (n=190) to test whether Feeling Safe-NL helps patients improve
their wellbeing and feel safer more effectively than CBTp. We will include
out-patients with threat beliefs that are held with at least 60% conviction and
the presence of at least two of the seven most important causal maintenance
factors of threat beliefs, such as trauma-imagery and insomnia. Participants
will be randomised (1:1) to Feeling Safe-NL or the gold-standard CBTp
(protocolized, formulation-based), both provided over a period of 6 months. In
line with the treatment protocols, participants in both conditions are offered
the possibility to monitor their wellbeing, threat
beliefs, maintenance factors (trauma-imagery, insomnia, self-esteem, worry,
anomalous experiences, safety behaviours), personal recovery goals, and
resilience. Data will be visualised in a novel and patient-friendly way to
enhance usability for both patients and therapists. Standard care will continue
as usual and be monitored. Blinded assessments will be conducted at 0, 6-
(post-treatment), 12- and 18-months follow-up. The primary outcome is wellbeing
and the secondary outcome is the level of conviction of the main threat belief.
We will use Linear Mixed Models (LMM) and Generalised Estimating Equations
(GEE) analyses for the main outcomes. For cost-effectiveness analyses, the
clinical end-terms are a clinically relevant change in wellbeing and
quality-adjusted life-year gained. We will also use mediation analyses to
assess mechanisms of therapeutic change. All main analyses will be
intention-to-treat (ITT). The project also includes qualitative assessments of
the experiences of participants, therapists, and experts by experience with the
Feelings Safe-NL programme.

Feeling Safe-NL

1) Rationale
The aim of Feeling Safe-NL is to reduce obstacles that hamper the recovery
process while concurrently addressing personal recovery to promote wellbeing.
This approach enables synergy between the work of the therapist, peer
counsellor, and participant. The overarching goals of the Feeling Safe-NL
programme are: to feel safer, happier, and get people back to doing what they
want to do (Freeman & Waite, 2017). The empirically-based maintenance factors
of threat beliefs (trauma-imagery, insomnia, self-esteem, worry, anomalous
experiences, safety behaviours) are assessed. A personalised menu of treatment
options is provided to the patient and modules are selected based on patient
choice, allowing maintenance factors to be tackled one-by-one in separate brief
therapy modules. This approach helps to address both the complexity and unicity
of presenting problems and commonly associated feelings of hopelessness.

Participants will have an initial introductory meeting with the professional
peer counsellor and therapist. All share their pitfalls/vulnerabilities and
things they like or do well, to promote the experience of openness and trust.
Information about the Feeling Safe-NL programme is provided, and the
collaboration is discussed. Participants will be asked to invite loved ones or
relevant resource group members to this meeting. In the following two meetings,
the participant and the peer counsellor share personal experiences and work on
identifying strengths, wishes, and possibilities for different aspects of life
using the Strengths Assessment (Rapp & Goscha, 2011). This results in a report
with a strengths profile and wishes and needs profile. The strengths profile is
the starting point for peer counselling. The therapist discusses the wishes and
needs profile with the participant during their first assessment, after which a
personalised menu of treatment options is offered to the participant. On
average three therapy modules will be selected and
participant and therapist work together on reducing maintenance factors
one-by-one in brief CBT modules. The therapist and client formulate recovery
goals at the beginning of therapy. The participant and the therapist meet every
week to work on the obstacles that hamper attainment of these recovery goals.
The peer counsellor and participant work together according to the sponsor
model (Brown, 1995): the expert by experience is available to support the
participant during the Feeling Safe-NL programme, and the participant can
decide when and how to have contact. Possibilities and impossibilities are
discussed, and the peer counsellor asks if he/she can contact the participant
following a period of no contact to check how the person is doing. The peer
counsellor and the participant work together on improving wellbeing through
sharing of experiences, finding meaning in past and current experiences, and
engaging in meaningful activities. The participant, therapist, and peer
counsellor meet near the end of every therapy module to evaluate progress and
discuss the transition to the next therapy module. This enhances the synergy
between the work of the therapist and peer counsellor together with the
participant. On the one hand, obstacles are removed while on the other hand
personal recovery is promoted, both with an aim of attaining wellbeing. The
participant, loved ones or resource group members, therapist, and peer
counsellor meet at the end of The Feeling Safe-NL Programme to evaluate the
therapy and discuss how the improved wellbeing and feelings of safety can be
maintained.

Cognitive behaviour therapy for psychosis (CBTp)

1) Rationale
The aim of CBTp is to reduce the dysfunctional emotional and behavioural
consequences of threat beliefs. Cognitive interventions are used to challenge
cognitions and raise awareness of cognitive biases. Behavioural interventions
are used to reduce avoidance behaviours, stimulate gradual exposure to the
alleged threat to challenge the expectancy of negative outcomes and to test
more functional coping strategies.

Participants will have an initial assessment with a psychologist in which the
therapy goals are identified. Following this assessment, people will receive
protocolized formulation-based CBTp for threat beliefs (Van Der Gaag, Staring,
Van Den Berg, & Baas, 2018). The treatment starts with an introductory meeting
in which the patient and therapist get to know each other. The therapist also
provides information about the rationale and set-up of the treatment, including
the frequency and duration of sessions. Participants will be asked to invite
loved ones or relevant resource group members to this meeting.Following the
introduction, the inventory phase starts. In this phase, more information is
gathered using the conspiracy interview and thought records. The participant
and therapist collaboratively work on understanding the problems of the
participant and on completing the case formulation, which provides relevant
information concerning the origin and maintenance of the patient*s threat
beliefs. The therapist and client also work together on formulating treatment
goals. The intervention phase starts after the case formulation is completed.
Generally, cognitive interventions (psycho-education, historic testing, and
evidence for and against the threat beliefs) are used first with an aim of
creating more nuances in the fixed
threat beliefs and encouraging patients to participate in behavioural
experiments and exposure assignments. This cycle may need to be repeated to
challenge each relevant dysfunctional belief. In this phase, the patient and
therapist always agree on assignments to do between sessions. The last phase is
the consolidation phase in which the therapist and participant review the
participant*s earlier difficulties and examine whether all of them have now
been overcome. They evaluate the steps the participant has taken to restore her
everyday life, and the actions that are still needed. The participant is asked
to write down the most important changes and learning points from the
treatment. This written evaluation can be taken home so that it can be used in
case of recurring symptoms. Together with the participant, the therapist goes
through the form for the prevention of recurring paranoid thoughts. Loved ones
or relevant resource group members will be involved in this phase.

Minimal burden due to short one hour assessments. The administration of
questionnaires is also a standard part of cognitive behaviour therapy (standard
care). As a result, the extra burden is less than 30 minutes. Only the
assessments of demographics, the therapeutic relationship and
cost-effectiveness is not routinely used in clinical practice. There are no
risks associated with the therapy.