Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001018404
Ethics application status
Approved
Date submitted
25/07/2016
Date registered
2/08/2016
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting Depression in the Lesbian, Gay, and Bisexual Population
Scientific title
Effect of Compassion Focused Therapy on Depression in the Lesbian, Gay, and Bisexual Youth (aged 18-25) Population
Secondary ID [1] 289746 0
Nil known
Universal Trial Number (UTN)
U1111-1185-6275
Trial acronym
CFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 299593 0
Condition category
Condition code
Mental Health 299562 299562 0 0
Depression
Mental Health 299609 299609 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CFT (Compassion Focussed Therapy) for Depression study; Participants in the CFT intervention will receive and complete a CFT workbook for targeting depression and have 8 x individual 1-hour Skype sessions, once/ week for 8 weeks with a Provisional Psychologist. The CFT intervention will focus on completion of weekly modules within the provided workbook, providing psychoeducation about the onset of depression and emotion regulation, mindful self-compassion exercises, and adapting thinking and behaviours to become more compassion-oriented. A focus of sessions with therapists will be the practicing of skills in session, problem-solving difficulties in engaging in skills, and providing support and encouragement for participants to complete workbook content. Provisional Psychologists are all enrolled in post-graduate Clinical Psychology degrees. The intervention will occur in the participant’s home and the La Trobe University Psychology Clinic using Skype software. Intervention adherence will be assessed by a Research Assistant; the therapist will tick a checklist each session of required topics and exercises completed (e.g., review of homework between sessions, completion of a mindfulness activity), which the Research Assistant will check weekly. Treatment fidelity will be improved by regular supervision from a Clinical Psychologist informed of any reductions in adherence.
Intervention code [1] 295384 0
Treatment: Other
Comparator / control treatment
Guided self-help bibliotherapy. The control condition will receive and read selected sections of a self-help for depression book (Feeling Good, Authored by David Burns), while having 1 x 1 hour Skype session with a Provisional Psychologist four weeks into the eight week guided bibliotherapy to assess compliance and troubleshoot any difficulties in completing the tasks.
Control group
Active

Outcomes
Primary outcome [1] 299038 0
% with Beck depression score equal to or under 13; Beck Depression Inventory-II
Timepoint [1] 299038 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Primary outcome [2] 299045 0
Proportion of participants with a significant difference in mean scores on Beck Depression Inventory-II between time-points and between control and experimental conditions.
Timepoint [2] 299045 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Secondary outcome [1] 325945 0
% with Beck anxiety score equal to or less than 7; Beck Anxiety Inventory
Timepoint [1] 325945 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Secondary outcome [2] 325946 0
Proportion of participants with a significant difference in mean scores on Suicidal Behaviours (assessed using the Suicidal Behaviours Questionnaire) between time-points and between control and experimental conditions.
Timepoint [2] 325946 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Secondary outcome [3] 325947 0
Proportion of participants with a significant difference in mean scores on internalised homophobia (assessed using the Lesbian, Gay, Bisexual Identity Scale) between time-points and between control and experimental conditions.
Timepoint [3] 325947 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Secondary outcome [4] 325948 0
Proportion of participants with a significant difference in mean scores on self-compassion (assessed using the Self-Compassion Scale-Short form) between time-points and between control and experimental conditions.
Timepoint [4] 325948 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Secondary outcome [5] 325949 0
Proportion of participants with a significant difference in mean scores on shame-proneness (assessed using the Guilt and Shame Proneness Scale) between time-points and between control and experimental conditions.
Timepoint [5] 325949 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion
Secondary outcome [6] 325971 0
Proportion of participants with a significant difference in mean scores on anxiety (assessed using the Beck Anxiety inventory) between time-points and between control and experimental conditions.
Timepoint [6] 325971 0
Baseline, 1-week post-intervention completion, and 3-months post-intervention completion

Eligibility
Key inclusion criteria
1) Proficient in English language; 2) A score of 13 or higher on the Beck Depression Inventory-II, indicating mild or greater depressive symptomatology; 3) Identifying as gay, lesbian, bisexual, or non-heterosexual
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current engagement in individual psychotherapy; 2) Current plan or intent to engage in suicidal and/or para-suicidal behaviours

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS analysis software. Data analysis will include ANOVA and follow-up t-tests. To conduct the mixed between (groups) - within (time; pre-post-follow-up) ANOVA's at power = .8, alpha .05, and a small effect, we would need a total sample of at least 42 individuals. Thus, our sample of 50 individuals will be sufficient to analyse the effectiveness of the treatment, accounting for attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2016
Actual
9/08/2016
Date of last participant enrolment
Anticipated
6/10/2016
Actual
5/05/2017
Date of last data collection
Anticipated
30/09/2017
Actual
13/12/2017
Sample size
Target
50
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 13667 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 294129 0
University
Name [1] 294129 0
La Trobe University
Country [1] 294129 0
Australia
Primary sponsor type
Individual
Name
Dr. Chris Pepping
Address
Room 462, George Singer Building
Department of Psychology and Counselling
La Trobe University
Bundoora
Victoria
3083
Country
Australia
Secondary sponsor category [1] 292960 0
Individual
Name [1] 292960 0
Dr. Anthony Lyons
Address [1] 292960 0
Australian Research Centre in Sex, Health, and Society
School of Psychology and Public Health
La Trobe University
Franklin Street Campus
Melbourne
Victoria
3000
Country [1] 292960 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295534 0
La Trobe University Human Research Ethics
Ethics committee address [1] 295534 0
University Human Research Ethics Committee
Research Office
La Trobe University
Bundoora
Victoria 3083
Australia
Ethics committee country [1] 295534 0
Australia
Date submitted for ethics approval [1] 295534 0
15/02/2016
Approval date [1] 295534 0
28/04/2016
Ethics approval number [1] 295534 0
HEC16-010

Summary
Brief summary
The Compassion Focused Therapy (CFT) study aims to develop and evaluate a first-ever mindfulness-based compassion intervention to treat depression in lesbian, gay, and bisexual (LGB) Australians, a high-risk, underserved population. Participants will be 50 LGB adults aged 18-25 with mild-to-moderate depression, who will be randomly assigned to either the eight week compassion-focussed intervention which will be delivered via Skype, or to an active control condition whereby participants will work through a self-help book for depression which has been evaluated in prior research as effective, over an eight week period. Therapists will be Provisionally Registered Psychologists, with training and supervision from Clinical Psychologist, Dr. Chris Pepping. Participants will complete pre-intervention, post-intervention, and 3-month follow-up assessments to evaluate intervention effectiveness. Study outcomes include depression and anxiety symptoms, suicidal behaviours, internalised homophobia, self-compassion, and shame-proneness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67654 0
Dr Chris Pepping
Address 67654 0
Room 462 George Singer Building
School of Psychology and Public Health
La Trobe University
Bundoora
Victoria
3083
Country 67654 0
Australia
Phone 67654 0
+61394791490
Fax 67654 0
Email 67654 0
c.pepping@latrobe.edu.au
Contact person for public queries
Name 67655 0
Dr Chris Pepping
Address 67655 0
Room 462 George Singer Building
School of Psychology and Public Health
La Trobe University
Bundoora
Victoria
3083
Country 67655 0
Australia
Phone 67655 0
+61394791490
Fax 67655 0
Email 67655 0
c.pepping@latrobe.edu.au
Contact person for scientific queries
Name 67656 0
Dr Chris Pepping
Address 67656 0
Room 462 George Singer Building
School of Psychology and Public Health
La Trobe University
Bundoora
Victoria
3083
Country 67656 0
Australia
Phone 67656 0
+61394791490
Fax 67656 0
Email 67656 0
c.pepping@latrobe.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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