Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000730505
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
15/07/2015
Date last updated
15/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behaviour Therapy for Comorbid Anxiety and Sleep Disorders: A Randomized Controlled Trial
Scientific title
The Feasibility and Preliminary Effectiveness of Cognitive Behaviour Therapy in Treating Comorbid Youth Anxiety and Sleep-Related Problems: A Randomized Controlled Trial
Secondary ID [1] 286994 0
Nil
Universal Trial Number (UTN)
U1111-1171-6639
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 295458 0
Sleep-Related Problems 295459 0
Condition category
Condition code
Mental Health 295711 295711 0 0
Anxiety
Mental Health 295713 295713 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
[1. Cognitive Behaviour Therapy for Adolescents with Anxiety and Sleep-Related Problems
(CBT-A-A-SRP)]

Participants will be randomly allocated to one of two groups - the CBT treatment group or waitlist control group. Participants who were randomly allocated to participate in the Cognitive Behaviour Therapy for Anxiety and SRPs group will be asked to attend 10 weekly 90-minute treatment sessions. These treatment sessions involve learning more about their sleep patterns, sleep hygiene, stimulus control therapy and identifying unhelpful habits that may be contributing towards their sleep difficulties. Treatment sessions will also involve psychoeducation around anxiety as well as teaching contingency management, cognitive restructuring, relaxation training and stress management. Participants will be provided with an informational booklet during the program that contains relevant activities and worksheets that will be worked through in each of the treatment sessions. Participating in this form of therapy requires time and commitment. In order to make sustainable changes to their sleep habits and reduce their levels of anxiety, strategies that participants will learn in therapy need to be practiced in between sessions. Participants will therefore additionally be provided with a homework booklet that outlines relevant activities and strategies that must be completed in between treatment sessions. The time commitment required to complete homework tasks should not exceed 1 hour per week. Participants will be supported by provisionally registered Psychologists receiving advanced clinical training as part of their postgraduate studies. Sessions will be videotaped and blind observers utilised throughout the treatment phase to check for compliance with the treatment manual and ensure therapy tasks are equivalent across groups. Registered clinical psychologists will provide weekly supervision to therapists conducting the treatment. The 10 treatment sessions will be provided in small groups at the Griffith University Psychology Clinic. This will give participants an opportunity to meet each other and other people who are experiencing similar problems and support each other in making changes to their anxiety and sleep habits. Participants allocated to the waitlist control will receive the same CBT intervention however this will not be offered to participants until the post-treatment phase.

[2. Cognitive Behaviour Therapy for Parents of Adolescents with Anxiety and Sleep-Related Problems
(CBT-P-A-SRP)]

Parents of participants who were randomly allocated to participate in the Cognitive Behaviour Therapy for Anxiety and SRPs group will be asked to attend 4 90-minute treatment sessions. These treatment sessions involve psychoeducation regarding anxiety and sleep-related problems, contingency management strategies, cognitive restructuring strategies as well as effective techniques on how to support their child in maintaining the skills learnt within the treatment sessions. These sessions will be run concurrently with the CBT-A-A-SRP group and will be held in Weeks 1, 4, 8 & 10. The four treatment sessions will be also be provided in small groups at the Griffith University Psychology Clinic and will also be run by provisionally registered Psychologists receiving advanced clinical training as part of their postgraduate studies. Sessions will be videotaped and blind observers utilised throughout the treatment phase to check for compliance with the treatment manual and ensure therapy tasks are equivalent across groups. Registered clinical psychologists will provide weekly supervision to therapists conducting the treatment. These sessions will capitalise on research findings highlighting the clinical benefits of parental involvement as well as providing parents an opportunity to meet each other and other parents whose children might be experiencing similar problems and support each other in learning strategies that may facilitate positive changes in their child’s anxiety and sleep habits.
Intervention code [1] 292200 0
Behaviour
Intervention code [2] 292263 0
Treatment: Other
Comparator / control treatment
Participants in the control condition will not be offered the intervention until the post-treatment phase (after 10 weeks) at which time they will cease to be part of the study.
Control group
Active

Outcomes
Primary outcome [1] 295414 0
Anxiety (Anxiety Disorders Interview Schedule)
Timepoint [1] 295414 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Primary outcome [2] 295417 0
Insomnia (Insomnia Severity Index)
Timepoint [2] 295417 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [1] 315546 0
Anxiety (The Spence Child and Anxiety Scale)
Timepoint [1] 315546 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [2] 315547 0
Sleep Patterns (The Children’s Report of Sleep Patterns)
Timepoint [2] 315547 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [3] 315548 0
Worry (Penn State Worry Questionnaire)
Timepoint [3] 315548 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [4] 315549 0
Sleep Quality (Consensus Sleep Diary)
Timepoint [4] 315549 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [5] 315550 0
General Functioning (The Children’s Global Assessment Scale)
Timepoint [5] 315550 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [6] 315551 0
Emotional and Behavioural Problems (Youth Self-Report)
Timepoint [6] 315551 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [7] 315552 0
Quality of Life (Paediatric Quality of Life InventoryTM)
Timepoint [7] 315552 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [8] 315553 0
Interference in Functioning (The Child Anxiety Life Interference Scale)
Timepoint [8] 315553 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [9] 315554 0
Sleeping Chronotype (Composite Scale of Morningness)
Timepoint [9] 315554 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [10] 315555 0
Homework Compliance (Homework Compliance Measure developed by Park et al. 2014. Homework compliance will be assessed weekly and will based on parent and adolescent's report of the extent to which the assignment was completed).

Timepoint [10] 315555 0
Week 1 - 10 (Intervention)
Secondary outcome [11] 315556 0
Beliefs about Worry (The Meta-Cognitions Questionnaire)
Timepoint [11] 315556 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [12] 315557 0
Uncertainty (Intolerance of Uncertainty Scale)
Timepoint [12] 315557 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [13] 315558 0
Suppression of Intrusive Thoughts (White Bear Suppression Inventory)
Timepoint [13] 315558 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [14] 315559 0
Perfectionism (Child and Adolescent Perfectionism Scale)
Timepoint [14] 315559 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [15] 315560 0
Social Problem Solving (Social Problem Solving Inventory Revised)
Timepoint [15] 315560 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up
Secondary outcome [16] 315561 0
Obsessive Beliefs (Obsessive Beliefs Questionnaire)
Timepoint [16] 315561 0
Baseline (Pre), Week 10 (Post), 6-month Follow Up, 12-month Follow Up

Eligibility
Key inclusion criteria
Anxiety Disorder
Sleep-Related Problems
Parent/Guardian willing to participate in the Parent Sessions
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents with a pervasive developmental disorder, significant behavioural disorder, previous treatment with selective serotonin reuptake inhibitor, suicidal ideation, substance abuse or current self-harm will be excluded. Adolescents currently receiving psychological treatment elsewhere will also not be permitted in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to participate in the trial through media releases, advertisements in school newsletters, and through referral from general practitioners, school guidance officers and other mental health professionals.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to the treatment condition or waitlist condition via a computer generated randomization procedure using SPSS. Allocation will involve contacting a member of the research team at Griffith University.

Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be entered, screened and analysed using IMB SPSS Statistics (21.0). For this study, multilevel modelling will be used to determine treatment effectiveness for the continuous variables. Chi square analyses will be conducted to examine categorical variables. Outcome data will be reported in terms of statistical significance of differences between the CBT and WLC groups, differences in symptom severity and changes over time, clinical significance of changes and effect sizes. A large effect size (w = .7) is expected based on previous trials investigating CBT treatment for adolescent SRPs (Cain, Gradisar & Moseley, 2011; Moseley & Gradisar, 2009) and given the study is looking at differences in diagnostic status between a treatment and wait list control (rather than across a number of treatment groups). It was determined that a minimum sample size of 66 was needed to achieve a power of .8 with an alpha of .05 (Devilly, 2007). The sample size of 76 is therefore sufficient and will allow for dropout over the course of the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2015
Actual
Date of last participant enrolment
Anticipated
16/07/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9883 0
4122 - Upper Mount Gravatt

Funding & Sponsors
Funding source category [1] 291549 0
University
Name [1] 291549 0
Griffith University
Country [1] 291549 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Mt Gravatt Campus, Griffith University
176 Messines Ridge Road, Mt Gravatt, Queensland, 4122
Country
Australia
Secondary sponsor category [1] 290226 0
None
Name [1] 290226 0
Address [1] 290226 0
Country [1] 290226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293091 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293091 0
Ethics committee country [1] 293091 0
Australia
Date submitted for ethics approval [1] 293091 0
04/06/2015
Approval date [1] 293091 0
26/06/2015
Ethics approval number [1] 293091 0
PSY/B1/15/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58430 0
Dr Caroline Donovan
Address 58430 0
Griffith University Mount Gravatt Campus
M24 Psychology Building
176 Messines Ridge Road Mount Gravatt QLD 4122
Australia
Country 58430 0
Australia
Phone 58430 0
+61 (0)7 3735 3401
Fax 58430 0
+61 (0)7 3735 3388
Email 58430 0
[email protected]
Contact person for public queries
Name 58431 0
Hayley Bell
Address 58431 0
Griffith University Mount Gravatt Campus
M24 Psychology Building 2.04
176 Messines Ridge Road Mount Gravatt QLD 4122
Australia
Country 58431 0
Australia
Phone 58431 0
+61423396668
Fax 58431 0
Email 58431 0
[email protected]
Contact person for scientific queries
Name 58432 0
Caroline Donovan
Address 58432 0
Griffith University Mount Gravatt Campus
M24 Psychology Building
176 Messines Ridge Road Mount Gravatt QLD 4122
Australia
Country 58432 0
Australia
Phone 58432 0
+61 (0)7 3735 3401
Fax 58432 0
+61 (0)7 3735 3388
Email 58432 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.