A treatment components analysis of a stepped-care, CBT based treatment for adults with tinnitus: a replicated single-case experimental approach

Tinnitus is the perception of sound (excluding voices), often described as a
*ringing* or a high frequency tone, which occurs in the absence of an
identifiable source. Although approximately 20% of the adult population has
tinnitus, between 1-6% suffer from it (Bhatt, Lin, & Bhattacharyya, 2016; Cima,
Crombez, & Vlaeyen, 2011; Davis & Refaie, 2000; Kim et al., 2015; McCormack,
Edmondson-Jones, Somerset, & Hall, 2016). Tinnitus sufferers typically
experience severe distress and disturbances in many aspects of daily life
(Davis & Refaie, 2000; Tyler & Baker, 1983). Consensus has not been reached on
the exact physiological mechanisms causing tinnitus (Baguley et al., 2013)

Currently, a cognitive and behavioural theoretical framework is used to
understand how tinnitus negatively impacts on peoples* lives. It also provides
the foundation on which psychological strategies for management and treatment
of tinnitus related distress are built. In particular, the Fear Avoidance Model
(FA; Lethem, Slade, Troup, & Bentley, 1983; Vlaeyen, Crombez, & Linton, 2016;
Vlaeyen & Linton, 2000, 2012) and the Neurophysiological (NP; Jastreboff &
Hazell, 1993; Jastreboff, Hazell, & Graham, 1994), are used to explain
emotional and behavioural responses to tinnitus. The principles and techniques
of cognitive behavioural therapy (CBT; Beck, 1979; Clark & Fairburn, 1997;
Ellis & Grieger, 1986) are used as a basis for the psychological treatment of
tinnitus related distress and address the cognitive (e.g. catastrophising about
the meaning of tinnitus), emotional (e.g. fear, anxiety, depression) and
behavioural (e.g. avoidance) effects of the condition.

A recent high quality randomised controlled trial (RCT) found that a combined
psychological and audiological treatment using a stepped-care approach was
highly effective at reducing psychological distress and improving quality of
life (Cima et al., 2012). Those with relatively mild levels of tinnitus related
distress only received Step 1, while those with higher levels of distress and
impairment received an additional and more intense level of treatment (i.e.
Step 2). While the intervention is highly effective as a whole, further
research is required to discover what elements of it are most effective.

Primary Objective: To investigate, in a series of studies, what effect the
elements of CBT for tinnitus have on tinnitus distress.

Study 1: The objective of study 1 is to examine the effects of audiological
assessment, psychological assessment and a tinnitus related information session
and whether the order in which they are delivered makes a difference.

Study 2: The objective of study 2 is to examine the effects of receiving
treatment individually compared with in a group setting.

Study 3: The objective of study 3 is to study the effectiveness of exposure to
tinnitus and a relaxation exercise.

Secondary Objective: To examine whether there are differences/benefits between
daily diary compared with Ecological Momentary Assessment (EMA) methods with
regard to predicting and measuring responses to treatment.

The three studies will use a single-case experimental design. The single case
experimental design (SCED; also known as n = 1 design) is a method in which
intervention components can be examined, and is particularly useful in studying
interventions with large effect sizes (Baer, 1977) such as that reported in the
RCT of specialised CBT for tinnitus (Cima et al., 2012).

Part 1 - Examining Step 1 of Specialised Care
Study 1 will use an ABCD design, where A = a no intervention phase, B =
audiological assessment, C = tinnitus information session, and D =
psychological assessment. The order of components B, C and D will be varied as
described above. These elements make up Step 1 of specialised CBT for tinnitus.

Patients will be actively involved in this study 7 weeks and then for one day
at three months follow-up (from the date of the end of treatment).

Part 2: Examining Step 2 of Specialised Care
Study 2 will use an ABACA design, where A = no intervention phase, B =
individual intervention, and C = group intervention. The order of components B
and C will be changed.

Patients will be actively involved in this study 12 weeks and then for one day
at three months follow-up (from the date of the end of treatment).

Study 3 will use an ABCD design, where A = a no intervention phase, B =
exposure sessions, C = relaxation exercises, D = exposure and relaxation
sessions combined. The order of components B, C and D will be switched as
described above.

Patients will be actively involved in this study 12 weeks and then for one day
at three months follow-up (from the date of the end of treatment).

Specialised stepped-care CBT for tinnitus.

The burdens and risks associated with participation in this study are
non-existent. The study-specific unique additional activity we ask from
participating patients is for them to respond to a set of brief questions 7
times per day about their current state (that is, ecological momentary
assessment), and complete a daily-diary once per day during a pre- intervention
(baseline) period, the active treatment phase and a post intervention
(post-test) period (that is a total of 12 weeks).

The use of ecological momentary assessment and daily diaries, and the strain it
might pose on patients has been considered thoroughly and the effects are
twofold: 1) it is possible that patients might feel inconvenienced at times due
to the prompts to respond to the questionnaires, 2) on the other hand,
patient-reports suggest that the actual activity of monitoring and describing
their functioning by the end of the day has increased their learning-ability
and increased insights in their own 'illness behaviour' favourably, which is
especially helpful in these types of interventions.

The benefits for patients are:
1. Patients will be enrolled in treatment fairly quickly
2. Patients will receive continuous feedback on their progress.