Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000378426
Ethics application status
Approved
Date submitted
16/03/2016
Date registered
23/03/2016
Date last updated
19/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Group metacognitive therapy for repetitive negative thinking: Evaluation in a transdiagnostic adolescent sample
Scientific title
Group metacognitive therapy for repetitive negative thinking: Evaluation in adolescents with anxiety or depression.
Secondary ID [1] 288774 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 298036 0
Anxiety 298037 0
Condition category
Condition code
Mental Health 298193 298193 0 0
Anxiety
Mental Health 298194 298194 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The group metacognitive treatment protocol (Anderson & Campbell, 2011) involves weekly two-hour group sessions, held over six weeks. Two follow-up sessions will also be held at 1 month and 3 months after the final treatment session. Minor amendments may be made to the protocol to ensure it is appropriate for an adolescent population, though the session structure will remain intact and involves the following components: Session 1 involves psychoeducation about maintain factors including repetitive negative thinking, metacognitive beliefs and counterproductive coping strategies. Session 2 involves targeting beliefs about the uncontrollability of worry and introduces attentional training and worry postponement. Session 3 involves challenging negative metacognitions about the danger of repetitive negative thinking and consists of evidence testing and behavioural experiments as homework. Session 4 focuses on challenging positive metacognitive beliefs, again through the process of evidence testing and behavioural experiments. Session 5 consists of increased emphasis on worry postponement and the use of active coping. Session 6 involves a review and the development of individual management plans. The follow-up sessions will involve a review of progress and management plans. Treatment fidelity will be ensured through adherence to the treatment manual in weekly supervision sessions. Sessions will also be recorded and rated for adherence by an independent rater. Groups will be facilitated by clinical psychology trainees under the supervision of experienced clinical psychologists, including the treatment manual author who has run the group numerous times with adult participants.
Intervention code [1] 294214 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297695 0
Level of unhelpful metacognitive beliefs, assessed by the Metacognitions Questionnaire for Children (MCQ-C).
Timepoint [1] 297695 0
3 baseline assessments in the two weeks prior to the intervention, pre-treatment, at the third treatment session, post treatment, at one and three month follow up.
Primary outcome [2] 297696 0
Level of worry, as assessed by the Penn State Worry Questionnaire for Children (PSWQ-C).
Timepoint [2] 297696 0
3 baseline assessments in the two weeks prior to the intervention, pre-treatment, at the third treatment session, post treatment, at one and three month follow up.
Primary outcome [3] 297697 0
Level of rumination, as measured by the Ruminative Responses Scale (RRS) - brooding subscale.
Timepoint [3] 297697 0
3 baseline assessments in the two weeks prior to the intervention, pre-treatment, at the third treatment session, post treatment, at one and three month follow up.
Secondary outcome [1] 321897 0
Level of repetitive negative thinking, as measured by the Repetitive Thinking Questionnaire (RTQ-10).
Timepoint [1] 321897 0
3 baseline assessments in the two weeks prior to the intervention, pre-treatment, at the third treatment session, post treatment, at one and three month follow up.
Secondary outcome [2] 321900 0
Mini International Neuropsychiatric Interview for Children and Adolescents 7 (MINI-KID 7; Sheehan, Shytle, Milo, Janvas, & Lecrubier, 2009) will be administered to establish participant diagnoses.
Timepoint [2] 321900 0
Baseline, post treatment, 1 and 3 month follow up.
Secondary outcome [3] 321904 0
Treatment acceptability - Satisfaction and acceptability of treatment will be assessed via a brief treatment acceptability questionnaire (developed for the purposes of this study) that will require participants to specify their level of agreement with various statements (e.g., ‘This form of treatment was helpful in addressing my difficulties’, ‘I would recommend this treatment to a friend’) on a 5-point Likert-scale (i.e., ranging from 1 ‘Strongly Disagree’ to 5 ‘Strongly Agree’).
Timepoint [3] 321904 0
Post treatment only

Eligibility
Key inclusion criteria
(a) aged 14 to 17 years, (b) a diagnosed anxiety or depressive disorder, (c) clinical levels of RNT (i.e., scores fall above the mean cut-off from normative data) as indicated by scores on the PSWQ-C or Brooding subscale of the RRS
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) concurrent psychological treatment for their presenting problem, b) moderate-high suicide or self-harm risk, (c) substance addiction, (d) psychotic symptoms (e) medication use that is not closely monitored by a health professional or recent changes in psychiatric medication dose (i.e., within the previous 1 month).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A-B case series procedure (Barlow & Hersen, 1984) which will involve (a) a 2-week baseline period in which stability of participant symptoms are assessed 3 times prior to treatment, (b) a brief 6-session group MCT intervention, (c) A post-treatment assessment, and (d) 1-month and 3-month follow-up assessment sessions.
Phase
Type of endpoint/s
Statistical methods / analysis
Treatment acceptability will be evaluated by recording of attendance and drop-out rates, in addition to client feedback on a brief treatment acceptability questionnaire completed at the conclusion of treatment. Scores on the acceptability measure will be summed to calculate a total score. Higher scores are indicative of a greater degree of client acceptability of the treatment program.
Treatment outcome will be determined by calculating the proportion of participants who have achieved reliable and clinically significant change, based on the criteria suggested by Jacobson and Traux (1991). Pre-treatment, post-treatment and follow-up (1 month, 3 month) scores on each outcome measure will be compared (e.g., pre-treatment to post-treatment) for each participant.
No formal sample size calculation performed. The treatment group will comprise 6-8 participants, as this size is recommended to allow for therapists to attend appropriately to clients’ idiosyncratic beliefs within transdiagnostic group treatment (McEvoy et al., 2015).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2016
Actual
Date of last participant enrolment
Anticipated
25/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293137 0
Self funded/Unfunded
Name [1] 293137 0
NA
Country [1] 293137 0
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 291933 0
None
Name [1] 291933 0
NA
Address [1] 291933 0
NA
Country [1] 291933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294634 0
Human Reseach Ethics Committee - Curtin University
Ethics committee address [1] 294634 0
Ethics committee country [1] 294634 0
Australia
Date submitted for ethics approval [1] 294634 0
16/12/2015
Approval date [1] 294634 0
09/03/2016
Ethics approval number [1] 294634 0
HR37/2016

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

Contacts
Principal investigator
Name 64438 0
Dr Rebecca Anderson
Address 64438 0
GPO BOx U1987, Perth WA 6845
Country 64438 0
Australia
Phone 64438 0
+61 8 9266 3012
Fax 64438 0
Email 64438 0
[email protected]
Contact person for public queries
Name 64439 0
Rebecca Anderson
Address 64439 0
GPO BOx U1987, Perth WA 6845
Country 64439 0
Australia
Phone 64439 0
+61 8 9266 3012
Fax 64439 0
Email 64439 0
[email protected]
Contact person for scientific queries
Name 64440 0
Rebecca Anderson
Address 64440 0
GPO BOx U1987, Perth WA 6845
Country 64440 0
Australia
Phone 64440 0
+61 8 9266 3012
Fax 64440 0
Email 64440 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.