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Trial registered on ANZCTR


Registration number
ACTRN12620000028909
Ethics application status
Approved
Date submitted
8/12/2019
Date registered
17/01/2020
Date last updated
9/01/2023
Date data sharing statement initially provided
17/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive behavioural therapy and hypnosis in the treatment of major depressive disorder: A randomised control trial
Scientific title
Cognitive behavioural therapy and hypnosis in the treatment of major depressive disorder: A randomised control trial
Secondary ID [1] 299836 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 315216 0
Condition category
Condition code
Mental Health 313533 313533 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Overview

There will be 5 intakes (consisting of one CBT group and one CBTH group per intake) over a period of two years. Each intake will involve a pre-assessment period, then random allocation to treatment, followed by 10 consecutive weeks of group based treatment sessions delivered from 7pm-9pm. Each CBT and CBTH will receive the same core CBT treatment, delivered to each group on different nights during the same 10 week period. All groups will be followed up at post treatment, at 6 months and at 12 months.

Pre-assessments will be done via Zoom and online self report measures, and all face to face treatment will take place at the Robin Winkler Clinic, School of Psychological Science, at the University of WA. With pandemic protocols in place, all particpants will be encouraged to only attend sessions if healthy, and to observe social distancing when they do so. In the event of non-attendance due to illness or other reasons, shorter make-up sessions will be offered to participants in person or via zoom. Participants will be encouraged to complete weekly self report measures online. All online measures are completed anonymously using participant research numbers.

A specific CBT treatment manual will be developed for this study by the principal study investigator, who will also produce the hypnosis scripts. Home based practice will be set for all sessions and these relate to the themes covered in each session, along with listening to the recordings. Participants will be encouraged to use home based practice.

Each group based therapy session will last approx. 100 minutes (plus a midway break). Participants will receive a 'therapy file' which will contain weekly handouts covering the main themes for each treatment session, group exercise worksheets and self-report sheets (e.g. activity based self-monitoring forms, thought record forms), all of which have been specifically designed for this study.

The face to face treatment will be delivered to all groups by the principal investigator, who is an experienced clinical psychologist, with assistance from a co-facilitator (who will vary from group to group).

Fidelity assessments will be conducted on a randomly selected number of pre-assessment interviews and on a randomly selected number of CBTH and CBT treatment sessions.
Post treatment and follow up assessments will involve a combination of online self report measures and a short interview by a blinded research assistant using the MADRS (either via zoom or telephone).

The core treatment themes of each for the CBTH group are (same as the CBT group):

Session 1:
Welcome
COVID 19 management
Group rules and expectations
Psycho-education on Major Depression
Group Exercise: Why change? Roadblocks to change?
Home practice task assigned

Session 2:
Review home practice Session 1
Sleep and sleep hygiene
Goal setting: Specific, Measurable, Achievable, Realistic, Time (SMART) system, graded
tasks, implementation intentions
Group exercise: goal setting for sleep
Home practice task assigned

Session 3:
Review home practice Session 2
Automaticity, routine and daily activity
Increasing self awareness
Activity Scheduling Part I: Increasing fun and pleasure
Group exercise: Goal setting for fun and pleasure
Home practice task assigned

Session 4:
Review home practice Session 3
Activity Scheduling Part II: Meaningful activity (Life Areas, Values)
Trigger Response Avoidance Patterns (TRAPs)
Group exercise: Values and TRAPs
Home practice task assigned

Session 5:
Review home practice Session 4
Avoidance, TRAPs and Functional Analysis
Trigger Response Alternative Coping (TRACs)
Group exercise: TRACs
Home practice task assigned

Session 6:
Review home practice Session 5
Midway goal review
Rumination
Rumination management: TRAC or re-focus
Group exercise: Changing rumination
Home practice task assigned

Session 7:
Review home practice Session 6
Cognitive model (ABC)
Ambiguity
Self-talk: Automatic thoughts, assumptions, beliefs
Attribution style
Group exercise: Attribution style
Home practice task assigned

Session 8:
Review home practice Session 7
Cognitive distortions
Using evidence
Behavioural experiments and surveys
Group exercise: Realistic thinking
Home practice task assigned

Session 9:
Review home practice Session 8
Problem-solving (interpersonally)
Imagery rehearsal (interpersonally)
Role playing (interpersonally)
Group exercise: Problem solving
Home practice task assigned

Session 10:
Review home practice Session 9
Review key components
Goals review
Group exercise: Insurance Policy
Group closure and farewell

The only difference between the two treatment groups is the last 15-20 mins of each session. Following the core treatment (see above), the CBTH group will be given a different hypnosis based recording to listen to at the end of each session (drawing on the themes of that particular session), and at home in between sessions. These hypnosis recordings will be around 15-20 mins duration.


Intervention code [1] 316089 0
Treatment: Other
Comparator / control treatment
Treatment 2: cognitive behvaioural therapy group

The CBT group will receive exactly the same core therapy components as the CBTH group described above except that, instead of hypnosis script recordings, the CBT group will be played a recording of a Progressive Muscle Relaxation (PMR) procedure at the end of each ssession. They will be encouraged to listen to the PMR recording at home, as often as possible, in between sessions.


The core treatment themes of each for the CBT group are (same as the CBTH group):

Session 1:
Welcome
COVID 19 management
Group rules and expectations
Psycho-education on Major Depression
Group Exercise: Why change? Roadblocks to change?
Home practice task assigned

Session 2:
Review home practice Session 1
Sleep and sleep hygiene
Goal setting: Specific, Measurable, Achievable, Realistic, Time (SMART) system, graded
tasks, implementation intentions
Group exercise: goal setting for sleep
Home practice task assigned

Session 3:
Review home practice Session 2
Automaticity, routine and daily activity
Increasing self awareness
Activity Scheduling Part I: Increasing fun and pleasure
Group exercise: Goal setting for fun and pleasure
Home practice task assigned

Session 4:
Review home practice Session 3
Activity Scheduling Part II: Meaningful activity (Life Areas, Values)
Trigger Response Avoidance Patterns (TRAPs)
Group exercise: Values and TRAPs
Home practice task assigned

Session 5:
Review home practice Session 4
Avoidance, TRAPs and Functional Analysis
Trigger Response Alternative Coping (TRACs)
Group exercise: TRACs
Home practice task assigned

Session 6:
Review home practice Session 5
Midway goal review
Rumination
Rumination management: TRAC or re-focus
Group exercise: Changing rumination
Home practice task assigned

Session 7:
Review home practice Session 6
Cognitive model (ABC)
Ambiguity
Self-talk: Automatic thoughts, assumptions, beliefs
Attribution style
Group exercise: Attribution style
Home practice task assigned

Session 8:
Review home practice Session 7
Cognitive distortions
Using evidence
Behavioural experiments and surveys
Group exercise: Realistic thinking
Home practice task assigned

Session 9:
Review home practice Session 8
Problem-solving (interpersonally)
Imagery rehearsal (interpersonally)
Role playing (interpersonally)
Group exercise: Problem solving
Home practice task assigned

Session 10:
Review home practice Session 9
Review key components
Goals review
Group exercise: Insurance Policy
Group closure and farewell
Control group
Active

Outcomes
Primary outcome [1] 321984 0
Patient Health Questionnaire-9
Timepoint [1] 321984 0
There will be 5 intakes of two groups (CBT and CBTH) over a two year period. The 4 time points will vary depending on the intake period. For example, Intake 1 commenced in July 2020, so the 4 time points are: baseline (July 2020), post-treatment (September 2020), 6 month follow-up (March 2021) [primary time-point] and 12 month follow-up (September 2021).
Primary outcome [2] 321985 0
Montgomery Asberg Depression Rating Scale – Clinician
Timepoint [2] 321985 0
There will be 5 intakes of two groups (CBT and CBTH) over a two year period. The 4 time points will vary depending on the intake period. For example, Intake 1 commenced in July 2020, so the 4 time points are: baseline (July 2020), post-treatment (September 2020), 6 month follow-up (March 2021) [primary time-point] and 12 month follow-up (September 2021).
Primary outcome [3] 321986 0
Overall Anxiety Severity and Intensity Scale (OASIS)
Timepoint [3] 321986 0
There will be 5, or more, intakes of two groups (CBT and CBTH) over a two year period. The 4 time points will vary depending on the intake period. For example, Intake 1 commenced in July 2020, so the 4 time points are: baseline (July 2020), post-treatment (Sept 2020), 6 month follow-up (March 2021) [primary time-point] and 12 month follow-up (September 2021).
Secondary outcome [1] 376922 0
Cognitive Behaviour Therapy Survey Questionnaire
Factor analysis shows that there are two primary factors being measured by this survey- behavioural activation and cognitive restructuring. I am interested in assessing both of these factors.
Timepoint [1] 376922 0
At 12 time points: -Baseline (July 2020) -Sessions 1-9 (July-Sept 2020) -Post-treatment (Sept 2020) -6 month follow-up (Mar 2021) [primary time point] -12 month follow-up (Sept 2021).
Secondary outcome [2] 377150 0
Ruminative Response Scale- Short Form
Timepoint [2] 377150 0
At 12 time points: -Baseline (July 2020) -Sessions 1-9 (July-Sept 2020) -Post-treatment (Sept 2020) -6 month follow-up (Mar 2021) [primary time point] -12 month follow-up (Sept 2021).
Secondary outcome [3] 377151 0
PROMIS Sleep Disturbance - Short Form B
Timepoint [3] 377151 0
At 12 time points: -Baseline (July 2020) -Sessions 1-9 (July-Sept 2020) -Post-treatment (Sept 2020) -6 month follow-up (Mar 2021) [primary time point] -12 month follow-up (Sept 2021).
Secondary outcome [4] 377152 0
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Timepoint [4] 377152 0
At 4 time points: -Baseline (July 2020) -Post-treatment (Sept 2020) -6 month follow-up (Mar 2021) [primary time point] -12 month follow-up (Sept 2021).
Secondary outcome [5] 377153 0
The Credibility/Expectancy Questionnaire
Timepoint [5] 377153 0
At baseline, then weekly, across the 10 sessions: -Session 1 July (2020) - Session 10 Sept (2020)
Secondary outcome [6] 377154 0
Home Practice Scale - a measure designed for this research.
The outcome being assessed is compliance.
Timepoint [6] 377154 0
Weekly, across the 10 sessions: -Session 1 July (2020) - Session 10 Sept (2020)
Secondary outcome [7] 377955 0
Clinically Useful Depression Outcome Scale (CUDOS)
Timepoint [7] 377955 0
Used weekly across 10 sessions: -Session 1 July (2020) - Session 10 Sept (2020)
Secondary outcome [8] 377956 0
Clinically Useful Anxiety Outcome Scale (CUXOS)
Timepoint [8] 377956 0
Weekly, across the 10 sessions: -Session 1 July (2020) - Session 10 Sept (2020)

Eligibility
Key inclusion criteria
1. Aged between 18-65 years;
2. Competency in English (both reading comprehension and written);
3. MDD diagnosed on a clinical interview using the MINI (and screened online using the PHQ-9);
4. No active suicidal ideation;
5. Does not have a disqualifying co-morbid diagnosis based on the MINI (i.e. Bi-polar Disorder, Psychosis, Personality Disorder, OCD, Alcohol/drug use Disoder (severe) or a primary Eating Disorder);
6. Is not currently receiving psychotherapy (or has in the past 12 months);
7. Can attend 10 weekly sessions during the time frame specified;
8. Is agreeable to being contacted by research assistants for telephonic and electronic based follow up assessments at 6 and 12 months post treatment;
9. Is agreeable to being randomly assigned to one of two treatment groups.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Although participants may meet the inclusion criteria, they will be excluded from enrolment in the study if:
1. They do not sign consent forms;
2. They are former clients of the principal researcher/therapist.

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)
Randomisation allocation will not be performed by the PhD investigator who is conducting the clinical trial but by a co-supervisor whose only task (during recruitment, assessment and treatment phases) is to conduct the randomisation. Hence, the co-supervisor is blinded to all information regarding each participant other than their gender and if their mood block rating (high or low). Participant research numbers accompanied by gender and mood block ratings will be sent for randomisation. This information will be entered into a computer program and randomisation codes for the treatment arm each participant is randomly allocated into will be generated electronically.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participant randomisation will follow CONSORT guidelines (Boutron et al. 2008) and will make use of stratification with blocking. Randomisation will be stratified by level of depression and by gender so that each treatment group (block) is approximately equivalent in terms of depression severity and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Online self report measures (weekly, post treatment and follow up) are completed using only participant research numbers to provide anonymity to respondents.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The aim was to enrol up to n=120 participants. Based on other MDD treatment studies, an attrition rate of 15-25% is anticipated. Alladin and Alibhai (2007) is the only published study which tested the CBT vs CBTH paradigm for MDD. A G-Power analysis was performed on their data (using a two tailed test, with a = .05 and power = .80, on the post/12mth follow up treatment effect sizes of d = .48/.22 for Mood, d = .58/.71 for Anxiety and d=.68/.53 for Hopelessness). This analysis revealed that a total sample size of 27, 18 and 12 participants would have been required at post across the three measures, and 155, 11 and 23 participants respectively at 12mth follow up. Stated differently, a general effect size of d=.29 would have been required to achieve a statistically significant result on the completed sample of 84

However, given the impact of COVID19 on recruitment, we have been only able to enrol and randomly allocate 66 participants.

Statistical analyses of the primary and secondary dependent variables will be based on an intention-to-treat principle. Comparisons of CBT with CBTH at the same time intervals (weekly, then at post treatment, 6 month and 12 month follow up) will be calculated using a linear mixed-effects modelling, with restricted likelihood estimation, adjusted for baseline values of the variable under investigation.

Treatment effect sizes (Cohen’s d/dig) for the primary and secondary dependent variables will also be calculated and this will enable comparisons between the CBT and CBTH treatments.

Correlational analyses will be used to assess mediating and moderating variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2020
Actual
20/07/2020
Date of last participant enrolment
Anticipated
5/02/2021
Actual
4/10/2021
Date of last data collection
Anticipated
31/12/2022
Actual
19/12/2022
Sample size
Target
120
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304295 0
University
Name [1] 304295 0
The University of WA
Country [1] 304295 0
Australia
Primary sponsor type
Individual
Name
Nicolino Ramondo
Address
Robin Winkler Clinic
School of Psychological Science
Myer Street
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 304540 0
Individual
Name [1] 304540 0
Dr Susan Byrne
Address [1] 304540 0
Robin Winkler Clinic
School of Psychological Science
Myer Street
Crawley WA 6009
Country [1] 304540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304751 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 304751 0
Ethics committee country [1] 304751 0
Australia
Date submitted for ethics approval [1] 304751 0
02/09/2019
Approval date [1] 304751 0
05/11/2019
Ethics approval number [1] 304751 0
RA/4/20/5703

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

Contacts
Principal investigator
Name 98082 0
Mr Nicolino Ramondo
Address 98082 0
Douro House
14 Douro Place
West Perth WA 6005
Country 98082 0
Australia
Phone 98082 0
+61 8 408473362
Fax 98082 0
+61 8 93229066
Email 98082 0
[email protected]
Contact person for public queries
Name 98083 0
Nicolino Ramondo
Address 98083 0
Douro House
14 Douro Place
West Perth WA 6005
Country 98083 0
Australia
Phone 98083 0
+61 8 408473362
Fax 98083 0
+61 8 93229066
Email 98083 0
[email protected]
Contact person for scientific queries
Name 98084 0
Nicolino Ramondo
Address 98084 0
Douro House
14 Douro Place
West Perth WA 6005
Country 98084 0
Australia
Phone 98084 0
+61 8 408473362
Fax 98084 0
+61 8 93229066
Email 98084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5722Study protocol  [email protected]
5991Informed consent form  [email protected]
5992Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTreating depression with hypnotherapy: A systematic review of randomized controlled trials.2022https://dx.doi.org/10.23736/S2724-6612.22.02303-X
N.B. These documents automatically identified may not have been verified by the study sponsor.