ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000139471

Ethics application status

Approved

Date submitted

2/02/2016

Date registered

5/02/2016

Date last updated

5/05/2022

Date data sharing statement initially provided

5/05/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Chilled Plus Program: Helping Adolescents with Anxiety and Depression.

Scientific title

The Feasibility and Outcome of Internet Delivery of Transdiagnostic Cognitive-Behaviour Therapy for Adolescent Anxiety and Depression

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1176-3545

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Chilled Plus program is a cognitive behavioural treatment that incorporates the latest research in working with negative emotions. The program consists of 8 online modules accompanied by weekly phone calls with a trained therapist. The treatment targets anxiety and depression symptoms. Modules are released on a weekly basis (adolescents complete one module per week before their phone session). All together there is around 4 hours of work to do each week including the module, completing homework tasks and engaging in the phone calls.

Module one provides psycho-education on the cycle of anxiety and depression, avoidance and managing emotions. It includes videos of people that have stories about their worries and moods (actors), and covers handling suicidal feelings.

Module two explores identifying avoidance patterns, developing goals and exploring values, identifying motivation levels and developing a list of enjoyable activities to begin regularly participating in.

Module three looks at the cost and benefits of avoidance, teaches the steps to goal-directed action to overcome avoidance and introduces the concept of stepladders.

Module four includes a review of the first stepladder created and making a plan for the next steps over the coming weeks. It includes common problems to stepladders and possible solutions. It also teaches new skills to work with negative emotions, and explores developing creative ways to boost motivation.

Module five highlights common thinking mistakes (e.g. catastrophising, filtering, overgeneralising, etc.) made by people with anxious or depressed feelings, teaches the basic steps of realistic thinking and continues with planning the next steps of the adolescents stepladder.

Module six covers different types of coping strategies and problem solving, as well as assertiveness training and how to handle teasing and bullying.

Module seven looks at how to overcome loneliness, how to build relationships, how to deal with family problems and further review of the next steps on the adolescents stepladders.

Module eight addresses what to do if things go wrong and symptoms reappear and looking to the future (e.g. further goal setting). It concludes with videos of the same people from module one talking about their lives since they used the skills in the program.

Each module requires participants to complete worksheets, monitor their thoughts, feelings and actions and complete personal projects (e.g. stepladder practice, mindfulness practice, etc..).

The phone calls with the adolescents occur once a week over the 8 week program and last for 25 minutes. The weekly phone calls with parents last 10 minutes, with the exception of Weeks 1, 5 and 8 consisting of 30 minute phone calls. These phone calls occur after the adolescents phone call. The aim of the calls with the adolescent is for the therapist to support the adolescent, help them problem solve any difficulties they might be experiencing in the program and to provide them with someone to talk to if things are difficult. The 10 minute phone calls with parents aims to provide a check in on how the child is going and how they are progressing with the program and to answer any questions the parents have around how best to support their child. The parents may also present questions from the content provided in the parent companion.

Treatment adherence for adolescents is monitored via data collected from the treatment website on login times, worksheet completion and pages viewed. Treatment adherence for clinicians is monitored via weekly supervision and the recording of all sessions for independent review to ensure treatment fidelity.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

A wait list control group is being utilised in the current study. Following the completion of an 8 week waiting period the participant receives the intervention.

Control group

Active

Outcomes

Primary outcome [1]

Number of diagnoses as measured by the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman & Albano, 1996) according to DSM-5 criteria.

Timepoint [1]

Diagnostic interviews will be conducted prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment.

Primary outcome [2]

Severity of diagnoses as measured by the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman & Albano, 1996) according to DSM-5 criteria.

Timepoint [2]

Diagnostic interviews will be conducted prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment.

Secondary outcome [1]

To measure change in symptomatology via the Short Mood and Feelings Questionnaire (SMFQ; Sharp, Goodyer & Croudace, 2006).

Timepoint [1]