Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000440325
Ethics application status
Approved
Date submitted
3/03/2017
Date registered
27/03/2017
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
MindCast: A randomised controlled trial of a podcast intervention for relationship separation
Scientific title
Testing the effectiveness of a web-based, audio podcast to improve adjustment for Australian adults who have recently separated from an intimate partner relationship
Secondary ID [1] 291294 0
None
Universal Trial Number (UTN)
Trial acronym
MindCast
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302222 0
Suicidal ideation 302223 0
Condition category
Condition code
Mental Health 301820 301820 0 0
Suicide
Mental Health 301821 301821 0 0
Depression
Mental Health 301917 301917 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2-arm randomised waitlist-controlled trial with a primary endpoint at 3 weeks and a 3-month follow-up, testing the effectiveness of a web-based, audio podcast (using computer, smartphone or tablet) program to improve adjustment following an intimate partner relationship separation.

The purpose of this intervention is to target individuals who have separated from a romantic relationship in the past six months, and use Brief Interpersonal Psychotherapy (IPT-B) strategies to promote active coping and positive adjustment and decrease suicidal ideation and symptoms of depression.

The podcast episodes are developed, written and narrated by a Clinical Psychologist. The podcast content is based on Brief Interpersonal Psychotherapy (IPT-B; Swartz et al., 2014), which is an eight session intervention adapted from the original evidence-based psychotherapy, Interpersonal Psychotherapy (IPT). The rationale for IPT-B is to provide an opportunity for individuals to be able to access the benefits of traditional IPT and who may not necessarily have the time or resources to be able to commit to a full 16 session intervention. Following clinical guidelines suggested by Stuart and Robertson (2012), relationship separation can be covered under the ‘role transition’ interpersonal problem area. It was determined that by focusing on one specific interpersonal problem area, the content of the podcast can be personalised to reflect on common aspects of a separation while allowing participants to experience the tactics and techniques specific to IPT delivery.

Content specific to the intervention includes: episode one – introduction to IPT, episode two – role transitions, episode three – interpersonal inventory, episode four – life events timeline, episode five – cons and pros of moving on, episode six – self-concept. Each podcast episode will run for a maximum of 15 minutes. Only the Clinical Psychologist will be heard on each episode.

Once the initial survey is completed, and following randomisation, participants will be invited to access each podcast episode via a link sent through to their email accounts. The link will redirect participants to an audio file embedded in a website (hosted by the Australian National University) where they can immediately listen to the podcast episode. Podcast episodes will be made available every three days in a sequential order. Participants will be emailed a new link every three days.

The remotely delivered trial will be advertised nationwide using social media and by approaching relevant mental health organisations. Three-week and three-month assessments will collect self-report measures of suicidal ideation and depression, as well as secondary outcomes (interpersonal needs, benefit-finding, adjustment, self-hate, and help-seeking ) and potential mediators (demographics) via online surveys. Fidelity and adherence will be assessed and reported as part of a process evaluation.

The podcasts are informed by interpersonal psychotherapy and social theories informing suicidal ideation and behaviours.
Intervention code [1] 297378 0
Prevention
Intervention code [2] 297548 0
Treatment: Other
Comparator / control treatment
The control group will be placed on the waitlist until the intervention period, and the first follow-up (3 months), is complete. Then participants in the control condition will be provided with full access to the program. The delivery of the program to the control condition will be identical to the initial intervention program. The intervention will be open for interested participants for 4-weeks after the completion of the original trial (after the final 3 month follow-up survey). After this period the intervention will no longer be available to the community to allow for analysis of data.

Control group
Active

Outcomes
Primary outcome [1] 301347 0
Suicidal ideation measure by the Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [1] 301347 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Primary outcome [2] 301516 0
Depression as measured by the Patient Health Questionnaire (PHQ-9)
Timepoint [2] 301516 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Primary outcome [3] 301517 0
Suicidal behaviours and attempts as measured by the Psychiatric Symptom Frequency Scale (PSF)
Timepoint [3] 301517 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Secondary outcome [1] 332374 0
Measuring a sense of Thwarted Belongingness and Perceived Burdensomeness using the
Interpersonal Needs Questionnaire (INQ)
Timepoint [1] 332374 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Secondary outcome [2] 332902 0
Measuring benefits using the General Benefit Finding Scale (GBFS)
Timepoint [2] 332902 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Secondary outcome [3] 332903 0
Measuring adjustment after the separation using the Psychological Adjustment to Separation Test (PAST)
Timepoint [3] 332903 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Secondary outcome [4] 332904 0
Measuring a sense of self-hate using the Self-Hate Scale (SHS)
Timepoint [4] 332904 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Secondary outcome [5] 332905 0
Measuring help-seeking using the Attitude Toward Seeking Professional Psychological Help-Short Form (ATPPSH)
Timepoint [5] 332905 0
Baseline, immediately after the intervention (3 weeks) and at 12-week follow-up.
Secondary outcome [6] 332906 0
Exploring where and how the podcasts were used using a Place of Use Questionnaire specifically designed for this study
Timepoint [6] 332906 0
Immediately after the intervention (3 weeks)
Secondary outcome [7] 332907 0
Measuring information processing using a Cognitive Load Questionnaire specifically designed for this study
Timepoint [7] 332907 0
Immediately after the intervention (3 weeks)
Secondary outcome [8] 332908 0
Measuring how stimuli was processed using the Elaboration Likelihood Model Questionnaire
Timepoint [8] 332908 0
Immediately after the intervention (3 weeks)
Secondary outcome [9] 332909 0
Exploring participants perception of the intervention with 9 specifically developed questions
Timepoint [9] 332909 0
Immediately after the intervention (3 weeks)
Secondary outcome [10] 332910 0
Open ended questions to capture any extra information:
- What did you find most valuable/helpful from the podcast program?
- What did you find least valuable/helpful from the podcast program?
-If you have any other comments on the podcast program, please enter them here:
Timepoint [10] 332910 0
Immediately after the intervention (3 weeks)

Eligibility
Key inclusion criteria
Participants are eligible for the study if they:
1. Are between 18 and 65 years of age
2. Have separated from a romantic relationship in the last six months
3. Are an Australian resident
4. Are able to competently understand the English language (both spoken and written)
5. Have or are willing to create an email account, and have access to the internet
6. Have access to, and basic ability to use a computer
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they:
1. Do not provide informed consent or refuse to be randomised
2. Are in a new relationship
3. Self-report a current suicide plan
4. Self-report a suicide attempt in the last month
5. Self-report a diagnosis of a substance-related disorder, post-traumatic stress disorder, schizophrenia, bipolar or a personality disorder.

For the purposes of this study, an intimate partner relationship is defined as: an interpersonal relationship between heterosexual or same-sex partners, which involved emotional and physical intimacy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Simple randomisation using a randomisation table created by computer software (Qualtrics)
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
For a moderate post intervention difference between the two groups (with power of .9 and alpha of .05) we would need 60 participants per group (120 in total).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2017
Actual
19/06/2017
Date of last participant enrolment
Anticipated
1/11/2017
Actual
17/07/2017
Date of last data collection
Anticipated
31/01/2018
Actual
22/12/2017
Sample size
Target
120
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295652 0
Other Collaborative groups
Name [1] 295652 0
Centre for Research Excellence in Suicide Prevention (CRESP)
Country [1] 295652 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Research Excellence in Suicide Prevention (CRESP)
Address
NHMRC Centre of Research Excellence in Suicide Prevention
Black Dog Institute
Hospital Road
RANDWICK, NSW, 2031
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 294496 0
University
Name [1] 294496 0
Australian National University
Address [1] 294496 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 2601
AUSTRALIA
Country [1] 294496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296970 0
ANU Human Research Ethics Committee
Ethics committee address [1] 296970 0
The Australian National University
Acton ACT 2601
Australia
Ethics committee country [1] 296970 0
Australia
Date submitted for ethics approval [1] 296970 0
15/02/2017
Approval date [1] 296970 0
03/04/2017
Ethics approval number [1] 296970 0
2017/089

Summary
Brief summary
A 2-arm randomised waitlist-controlled trial with a primary endpoint at 3 weeks and a 3-month follow-up, testing the effectiveness of a web-based, audio podcast (using computer, smartphone or tablet) program to improve adjustment following an intimate partner relationship separation. The purpose of this intervention is to target individuals who have separated from a romantic relationship in the past six months, and use Brief Interpersonal Psychotherapy (IPT-B) strategies to promote active coping and positive adjustment and decrease suicidal ideation and symptoms of depression.

The intervention is a web-based, six-session, online podcast program that can be accessed from any location with internet access. The intervention is free, confidential and easily accessible by people across Australia.

Assessments will be conducted at baseline, immediately after intervention (3 weeks) and at 12-week follow-up. Outcome measures will include demographics, mental health status, presence/severity of suicidal ideation, social support, positive adjustment, help seeking and the utility of the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72578 0
Ms Dominique Kazan
Address 72578 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 2601
AUSTRALIA
Country 72578 0
Australia
Phone 72578 0
+61 2 6125 2741
Fax 72578 0
Email 72578 0
[email protected]
Contact person for public queries
Name 72579 0
Ms Dominique Kazan
Address 72579 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 2601
AUSTRALIA
Country 72579 0
Australia
Phone 72579 0
+61 2 6125 2741
Fax 72579 0
Email 72579 0
[email protected]
Contact person for scientific queries
Name 72580 0
Ms Dominique Kazan
Address 72580 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 2601
AUSTRALIA
Country 72580 0
Australia
Phone 72580 0
+61 2 6125 2741
Fax 72580 0
Email 72580 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.