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Trial registered on ANZCTR


Registration number
ACTRN12617001165370
Ethics application status
Approved
Date submitted
22/07/2017
Date registered
8/08/2017
Date last updated
8/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
What should be treated first? Social anxiety or insomnia? A pilot study investigating the effects from cognitive behavioural therapy for people with comorbid social anxiety and insomnia.
Scientific title
A single case experimental design investigating the effects on sleep and anxiety from two different sequences of cognitive behavioural therapy for people with comorbid social anxiety and insomnia.
Secondary ID [1] 292502 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 304136 0
Social anxiety 304137 0
Condition category
Condition code
Mental Health 303471 303471 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name (Arm 1): Six individual sessions of cognitive behavioural therapy for social anxiety + four individual sessions of cognitive behavioural therapy for insomnia over ten weeks.
Brief name (Arm 2): Four individual sessions of cognitive behavioural therapy for insomnia + six individual sessions of cognitive behavioural therapy for social anxiety over ten weeks.
There was no washout period between the two treatments.

Cognitive behavioural therapy (CBT) is an evidence-based psychotherapy method for social anxiety and sleep problems respectively. The emphasis is on problems "here and now" rather than problems in the past. CBT includes a combination of cognitive techniques and behavioural techniques. The cognitive techniques strive to, in short, an increased awerness of negative thoughts and beliefs related to a specific disorder and to consciously strive to question or alter them. The aim is to learn to interpret situations in a more realistic manner. Behavioural techniques means trying new behaviors and approaches, as mental disorders often are maintained by dysfunctional behaviours such as avoiding any situation that might provoke anxiety. The treatment manuals used in this study have been scientifically tested.

CBT for insomnia included the following techniques: psychoeducation about sleep, stimulus control, sleep hygiene, sleep restriction, and constructive worry.
CBT for social anxiety includes the following techniques: psychoeducation about social anxiety, cognitive restructuring, exposure, and behavioural experiments.

Two master students in clinical psychology will conduct the therapies. The students have previous experience in clinical manual-based therapies. The sessions will be about one hour long each and be delivered face to face at Örebro University (Sweden). The therapists will receive supervision from two clinical psychologists (one expert on insomnia and one expert on social anxiety) with licenses to practice. The treatments will be manual-based and as such not personalised. Treatment fidelity will be assessed through the use of therapist check lists, to be completed by the therapists after every session.
Intervention code [1] 298686 0
Behaviour
Intervention code [2] 298687 0
Treatment: Other
Comparator / control treatment
In single case experimental designs, each participant acts as their own control. The baseline values from a pre-intervention period is compared to daily measures over the treatment period. The participants data from two weeks of baseline will be compared to data from seven weeks of treatment. In th current study, participants will be randomized to one of two sequences of CBT. Either first CBT for anxiety followed by CBT for insomnia, or first CBT for insomnia followed by CBT for social anxiety.
Control group
Active

Outcomes
Primary outcome [1] 302840 0
Primary outcome 1: changes in unwanted awake time in bed as measured by sleep onset latency (SOL) and wake after sleep onset (WASO). This is a composite primary outcome.
Timepoint [1] 302840 0
Time point: Every day for 7 days before treatment, every day during ten weeks of treatment, and during 7 days at follow-up four months later.
Primary outcome [2] 302841 0
Primary outcome 2: changes in social anxiety and worry as measured by a daily anxiety and worry log. This is a composite primary outcome.
Timepoint [2] 302841 0
Time point: Every day for 7 days before treatment, every day during ten weeks of treatment, and during 7 days at follow-up four months later.
Primary outcome [3] 302949 0
Primary outcome 3: Total sleep time (TST) as measured by daily sleep diaries.
Timepoint [3] 302949 0
Time point: Every day for 7 days before treatment, every day during ten weeks of treatment, and during 7 days at follow-up four months later.
Secondary outcome [1] 337210 0
Secondary outcome 1: insomnia severity as measured by the Insomnia Severity Index (ISI).
Timepoint [1] 337210 0
Time point: Three times during the 7 days of baseline measures, every week during the ten-week long treatment and once during the follow-up four months later.
Secondary outcome [2] 337211 0
Secondary outcome 2: changes in depressive symptomatology as measured by the Montgomery Asberg Depression Rating Scale (MADRS).
Timepoint [2] 337211 0
Time point: Three times during the 7 days of baseline measures, every week during the ten-week long treatment and once during the follow-up four months later.
Secondary outcome [3] 337212 0
Secondary outcome 3: changes in worry about sleep as measured by the Anxiety and Preoccupation about Sleep Questionnaire (APSQ).
Timepoint [3] 337212 0
Time point: Three times during the 7 days of baseline measures, every week during the ten-week long treatment and once during the follow-up four months later.
Secondary outcome [4] 337213 0
Secondary outcome 4: changes in social anxiety as measured by the Liebowitz Social Anxiety Scale-self report (LSAS-SR).
Timepoint [4] 337213 0
Time point: Three times during the 7 days of baseline measures, every week during the ten-week long treatment and once during the follow-up four months later.
Secondary outcome [5] 337214 0
Secondary outcome 5: changes in general worry as measured by Penn State Worry Questionnaire (PSWQ).
Timepoint [5] 337214 0
Time point: Three times during the 7 days of baseline measures, every week during the ten-week long treatment and once during the follow-up four months later.
Secondary outcome [6] 337216 0
Secondary outcome 6: experiences from the therapies as measured by qualitative interviews (up to 45 minutes long).
Timepoint [6] 337216 0
Time point: Once, one week after treatment has been completed.
Secondary outcome [7] 337534 0
Secondary outcome 7: Sleep efficiency (SE) as measured by daily sleep diaries.
Timepoint [7] 337534 0
Time point: Every day for 7 days before treatment, every day during ten weeks of treatment, and during 7 days at follow-up four months later.

Eligibility
Key inclusion criteria
The inclusion criteria were 1) insomnia diagnosis (as diagnosed through the structured clinical interview DSISD), 2) social anxiety diagnosis (Mini International Neuropsychiatric Interview (MINI) 3) not currently receiving other psychological treatments, 4) on a stable dose of medication over the last three months (if receiving pharmacological treatment).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were 1) Severe depression or suicidality as indicated by 30 or more on the MADRS, 4 or more on item 9 on the MADRS or discovered through clinical interview with the Mini International Neuropsychiatric Interview (MINI), 2) Not fulfilling diagnostic criteria for insomnia (DSISD), 3) Not fulfilling diagnostic criteria for social anxiety (MINI). 4) Currently receiving other psychological treatments, 5) changes in medication over the last three months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
When designing the study, care was taken to closely follow general quality criteria of single case experimental designs (SCED), meaning for example (but not limited to) sufficiently defined outcome criteria, long enough baseline period, randomisation of treatment start times, a minimum of five observations in each study phase for main outcome variables (baseline, treatment, and follow-up), and intersubject replication (multiple participants). Due to assumed irreversible effects of the therapy, intrasubject replication (varying baseline with treatment phases several times) was not conducted.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In SCED, conclusions are strengthened by the replication of findings over several participants. Guidelines sometimes mention at least three or five participants. Ten participants would allow for some potential attrition, thus this number was chosen.
The most established way of reporting results from single case studies is through graphs (so-called visual inspection). The basic idea is that if any significant change has occurred, it will be visible. The result of daily sleep measurements will therefore primarily be reported visually, and in accordance with established recommendations for how single case graphs should be presented to present results in a clear and correct manner. However, one should decide on what kind of visual differences that are meaningful for the current research question. Therefore, in the case of daily measurements of sleep, it is relevant to mark the number of nights where involuntarily time awake before falling asleep or in the middle of the night exceeds 30 minutes (frequently used research and diagnostic criteria at insomnia). If the occurrence of these nights decreases after treatment, then a clinically meaningful change has occurred. As statistical calculations are becoming increasingly common in SCED and required by newer guidelines, we plan to follow the methodological development and complement graphs report with appropriate statistical calculations. We refrain from deciding on a specific statistical method at this point, as we are currently investigating which would be the most appropriate method, but it is likely that the choice falls on a version of "time-series analysis" or "percentage of non-overlapping data" which can handle the specific mathematical circumstances that apply to SCED data, such as autocorrelation and variability within one phase. Results from questionnaires will be presented in tables. In cases where clinically significant differences have occurred, this will be highlighted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/08/2016
Date of last participant enrolment
Anticipated
Actual
20/10/2016
Date of last data collection
Anticipated
Actual
22/07/2017
Sample size
Target
10
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 9080 0
Sweden
State/province [1] 9080 0

Funding & Sponsors
Funding source category [1] 297073 0
University
Name [1] 297073 0
Örebro University
Country [1] 297073 0
Sweden
Funding source category [2] 297074 0
University
Name [2] 297074 0
Karlstad University
Country [2] 297074 0
Sweden
Primary sponsor type
Individual
Name
Maria Tillfors
Address
Karlstad University
SE-65188 Karlstad
Sweden

maria.tillfors@kau.se
Country
Sweden
Secondary sponsor category [1] 296077 0
Individual
Name [1] 296077 0
Annika Norell-Clarke
Address [1] 296077 0
Karlstad University
SE-65188 Karlstad
Sweden

annika.clarke@kau.se
Country [1] 296077 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298252 0
Regional Ethical Review Board in Uppsala (Sweden)
Ethics committee address [1] 298252 0
Regional Ethical Review Board in Uppsala (Sweden)
Box 1964
751 49 Uppsala
Sweden
Ethics committee country [1] 298252 0
Sweden
Date submitted for ethics approval [1] 298252 0
Approval date [1] 298252 0
17/08/2016
Ethics approval number [1] 298252 0
Dnr: 2016/302

Summary
Brief summary
The goal is to investigate the effects from cognitive behavioural therapy for insomnia and social anxiety respectively on participants with comorbid insomnia and social anxiety. Comorbidity between anxiety and insomnia is common, and research suggests a bidirectional relationship. However, few studies have examined the relationship between social anxiety disorder and insomnia, as well as how treatments for this comorbidity should be conducted. Participants will be randomised to receive one of two sequences: either CBT for anxiety + CBT for insomnia or CBT for insomnia + CBT for anxiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76478 0
Prof Maria Tillfors
Address 76478 0
Karlstad University
SE-65188 Karlstad Sweden
Country 76478 0
Sweden
Phone 76478 0
+4654700 21 89
Fax 76478 0
Email 76478 0
maria.tillfors@kau.se
Contact person for public queries
Name 76479 0
Maria Tillfors
Address 76479 0
Karlstad University
SE-65188 Karlstad Sweden
Country 76479 0
Sweden
Phone 76479 0
+4654700 21 89
Fax 76479 0
Email 76479 0
maria.tillfors@kau.se
Contact person for scientific queries
Name 76480 0
Annika Norell-Clarke
Address 76480 0
Karlstad University
SE-65188 Karlstad Sweden
Country 76480 0
Sweden
Phone 76480 0
+46547002569
Fax 76480 0
Email 76480 0
annika.clarke@kau.se

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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