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Managing Rumination and Worry: A randomised controlled trial of an internet delivered intervention targeting repetitive negative thinking.

A randomised controlled trial to compare the efficacy of a clinician-guided internet delivered intervention for repetitive negative thinking versus internet-delivered intervention without clinician guidance versus waitlist control.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000959976
Enrollment
137
Registered
2020-09-25
Start date
2020-08-25
Completion date
2021-03-31
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised controlled trial seeks to investigate the adherence rates and efficacy of an internet-delivered program for repetitive negative thinking immediately following treatment and at 3-months follow-up, and compare outcomes for clinician-guided versus self-guided online program.

Interventions

The internet-delivered Rumination and Worry program comprises 3 comic-style lessons completed over 6 weeks. It comprises psychoeducation about rumination and worry as well as techniques such as structured problem solving, attention shifting, activity planning and shifting into a more specific thinking style. One lesson will be released every 7 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons), with each participant taking betw

The internet-delivered Rumination and Worry program comprises 3 comic-style lessons completed over 6 weeks. It comprises psychoeducation about rumination and worry as well as techniques such as structured problem solving, attention shifting, activity planning and shifting into a more specific thinking style. One lesson will be released every 7 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons), with each participant taking between one and two weeks to complete each lesson (6 weeks in total). Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries of each lesson, homework exercises (e.g., self-monitoring, planning and engaging in distracting activities, practicing structured problem solving), and extra resources for each lesson. Participants are advised to spend at least 3-4 hours per week working through the lesson material, revisiting the content, and practicing the skills. Clinician guidance in the form of advice about the skills covered in the program will be provided to participants randomly allocated to the clinician-guided group. This will be in the form of email or phone contact from a clinician (provisional psychologist or registered clinical psychologist) after the completion of each lesson. It is expected that the duration of each clinical guidance session will be between 10 - 20 minutes per participant. Participants in the self-help group will complete the intervention in a self-help format and will not receive any additional clinical support or guidance. Participants in the self-help group and waitlist-control group can contact research staff for technical assistance at any point via phone or email. Participants in the two intervention groups will complete a measure of psychological distress before each lesson. Participants in the control group will complete this same measure at three time points across the trial as part of a larger questionnaire battery. Across all groups, if their scores increase by one or more standard deviation, the clinician is automatically alerted and initiates contact with the participant by phone or email. This mode of contact is dependent on what is clinically indicated in terms of the participant's distress score and or what the participant may have communicated (in the form of phone or email contact) to the clinician. The mode of contact (email or phone or both) therefore is dependent on the clinician's clinical judgement of the situation in hand. Strategies used to improve adherence to intervention protocols include standardised automated email and SMS reminders sent to participants whenever a new lesson or questionnaire is available, if they have not completed a lesson or questionnaire 4 and 8 days after it was released, and reminders to complete homework tasks 3 days after lesson completion. Strategies used to assess adherence to the intervention include monitoring the downloading of homework and collection of data on how long participants spent reading lessons and practicing skills.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Score above 27 on Repetitive Negative Thinking Questionnaire. * Australian resident status * At least 18 years of age * Access to a computer, printer, and the internet * If taking medication, must have been taking the same dose for at least 2 months and not intend to change that dose during the course of the program. * Prepared to provide name, phone number, and address, and to provide the name and phone number of a local general practitioner. * Willing to provide informed consent.

Exclusion criteria

- Currently experiencing severe depression symptoms (score of 23 or above on the PHQ-9). - Regularly using illicit drugs or regularly consuming more than three standard drinks per day - Current regular use of benzodiazepines - Current use of atypical anti-psychotics - Currently experiencing a psychotic mental illness or bipolar disorder - Completed an online program for depression and/or anxiety in the past year - Currently suicidal and/or severe symptoms of suicidal ideation (defined as responding 3 to the PHQ-9 question 9 item that assesses the frequency of suicidal ideation over the past fortnight). -Those scoring 1 or 2 on the Patient Health Questionnaire-9 Item (PHQ-9) item 9 will require risk assessment with the responsible clinician before being admitted into the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026