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Trial registered on ANZCTR


Registration number
ACTRN12615000816550
Ethics application status
Approved
Date submitted
13/07/2015
Date registered
7/08/2015
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an acceptance-focussed guided self-help programme reduce depressive symptoms in patients with vision impairment?
Scientific title
Does an acceptance-focussed guided self-help programme reduce depressive symptoms in patients with vision impairment? A pilot randomised controlled trial
Secondary ID [1] 287073 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision Impairment
 295573 0
Depression 295647 0
Condition category
Condition code
Eye 295845 295845 0 0
Diseases / disorders of the eye
Mental Health 295846 295846 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will integrate "third wave" cognitive-and-behavioural components of the Acceptance and Committment Therapy (ACT) Triflex into a guided self-help programme (i.e., the three functional units of ACT – be present, do what matters, and open up) with the aim to increase psychological flexibility. Our six modules are: (1) Understanding emotional well-being in vision impairment, (2) Being present, (3) Doing what matters, (4) Opening up, (5) Effective communication, and (6) Wellness planning.

The programme will be delivered in three individual face-to-face and three individual telephone consultations, of up to 50 minutes in duration per session, by a clinical psychologist. Sessions are administered once a week for 6 weeks. Two face-to-face visits will be followed by a telephone consultation, which is then followed by one face-to-face session and the remaining two telephone consultations. The weekly manual content is to be followed sequentially when the participant chooses, which is followed by guidance from the clinical psychologist in their sesisons.

Each intervention session will be recorded and the clinical psychologist will write a reflection on what was or was not effective following each session, with a view to developing a list of key intervention activities. We will record the number and duration of the face-to-face and telephone visits performed by the clinical psychologist. We will also record the time it took participants to follow the intervention (i.e., how long it took to complete each weekly session). After each session, the clinical psychologist will ask participants to describe how, and the extent to which they have used any strategies or intervention materials (i.e., the self-help manual provided in large print or for use with adaptive technology, includes readings, worksheets, and a description of skills to be practiced). In the evaluation interview, we will ask participants to describe the manner in which they followed the self-help course and the manner and extent to which they practiced their skills (in writing, cognitively, discussion etc.). Together, this information will be used to develop a measure of fidelity that will explore adherence to the programme and translation of therapy into daily life.
Intervention code [1] 292307 0
Treatment: Other
Intervention code [2] 292419 0
Behaviour
Comparator / control treatment
Usual care at vision rehabilitaiton plus a referral to GP. Usual care at Vision Australia is access to vision rehabilitaiton services plus a referral to see a GP if a client presents with depressive symptoms. We will also include a new sample of 60 paricipants with vision impairment who do not have symptoms of depression or score less than 5 on the PHQ-9 (i.e., those who have "normal" "nil" or "healthy" level of depressive symptoms) as a comparison sample.
Control group
Active

Outcomes
Primary outcome [1] 295531 0
depressive symptoms measured by the Patient Health Questionnaire 9-Items
Timepoint [1] 295531 0
3 and 6 months post baseline
Secondary outcome [1] 315786 0
Vision-related quality of life by The Impact of Vision Impairment (IVI) Questionnaire
Timepoint [1] 315786 0
3 and 6 months post baseline
Secondary outcome [2] 315974 0
Anxiety symptoms by the Hospital Anxiety and Depression Scale anxiety subscale (HADS-A)
Timepoint [2] 315974 0
3 and 6 months post baseline
Secondary outcome [3] 315975 0
Illness Cognitions will be examined via the Illness Cognition Questionnaire
Timepoint [3] 315975 0
3 and 6 months post baseline
Secondary outcome [4] 315977 0
Coping strategies via the Coping Strategy Indicator
Timepoint [4] 315977 0
3 and 6 months post baseline
Secondary outcome [5] 315978 0
Psychological inflexibility via the Acceptance and Action Questionnaire
Timepoint [5] 315978 0
3 and 6 months post baseline
Secondary outcome [6] 315979 0
Experiential avoidance via the Brief Experiential Avoidance Questionnaire
Timepoint [6] 315979 0
3 and 6 months post baseline
Secondary outcome [7] 315980 0
Participant evaluation of programme: In a separate telephone interview conducted within one month of the completed intervention and by a research assistant not masked to group allocation, participant views will be gathered on the programme content, convenience, delivery, participant-therapist relationship, and impact. Participants will be asked to rate the frequency, duration, format, delivery, content, materials, and perceived benefits. Response format vary from dichotomous “yes” and “no” to Likert 5-point scales as well as open ended questions. An example question is “The amount of information provided to me was…” “too much” to “too little.” Participants will be asked what their ideal distribution of self-help versus one-on-one sessions (includes telephone and face-to-face sessions) would be for the therapy dissemination ranging from 0 to 100%, and the qualitative benefits perceived from both. Participants will also be asked if any significant others (spouse, friends etc.) assisted them with the intervention or its implementation and how helpful this was.
Timepoint [7] 315980 0
Post intervention within 1 month of completion
Secondary outcome [8] 319496 0
Outcome: coping styles, assessed by the Brief-COPE
Timepoint [8] 319496 0
3 and 6 months post baseline
Secondary outcome [9] 319497 0
Outcome: well-being in ageing, assessed by the Philadelphia Geriatric Centre Morale Scale.
Timepoint [9] 319497 0
3 and 6 months post baseline
Secondary outcome [10] 319498 0
Outcome: participant GP service needs, assessed using the General Practitioner Users Percieved-Need Inventory.
Timepoint [10] 319498 0
3 and 6 months post bseline

Eligibility
Key inclusion criteria
(a) aged 18 years or older; (b) best corrected visual acuity less than 6/12 in the better eye; (c) a score of greater than or equal to five on the PHQ – Nine Items (PHQ-9); (d) ability to converse in English; (e) adequate hearing using a hearing aid if necessary; (f) not receiving any form of treatment for a mental health condition; (g) living independent in the community; (h) ability to read print materials in large print or with assistive technology; and (i) no cognitive impairment determined by the Cognitive Impairment Test – 6 Items (CIT6)

For the additional sample of 60 participants the same inclusion criteria will be used excluding "(c) a score of greater than or equal to five on the PHQ – Nine Items (PHQ-9)," which will be (c) a score of less than five ont he PHQ-9.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) a self-reported current diagnosis of a mental health condition other than depression or anxiety (e.g., personality, eating, substance misuse disorder); (b) suicidal intent requiring emergency care; (c) recently (within 3 months) commenced psychotropic medication; and (d) currently receiving any other form of psychological therapy.

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)
Following the baseline assessment, participants will be allocated to one of the three pilot arms. Those with a score of 5 or greater on the PHQ-9 will be randomised using a computer generated random number sequence, generated and concealed (sealed opaque envelopes) by a research member not involved in conducting the assessments or delivering the intervention. The follow-up interviews (post-intervention at 3-and 6-months) will be conducted by a research assistant masked to participant assignment. Any breaches of masking will be recorded and reasons obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a computer generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
End of funding at short notice
Date of first participant enrolment
Anticipated
9/01/2015
Actual
12/04/2016
Date of last participant enrolment
Anticipated
21/12/2017
Actual
21/12/2017
Date of last data collection
Anticipated
Actual
21/12/2017
Sample size
Target
120
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291633 0
Other
Name [1] 291633 0
Centre for Eye Research Australia
Country [1] 291633 0
Australia
Primary sponsor type
Other
Name
Centre for Eye Research Australia
Address
32 Gisborne St, East melbourne VIC 2002
Country
Australia
Secondary sponsor category [1] 290304 0
None
Name [1] 290304 0
NIL
Address [1] 290304 0
NIL
Country [1] 290304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293163 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 293163 0
32 Gisborne St, East Melbourne, VIC 3002
Ethics committee country [1] 293163 0
Australia
Date submitted for ethics approval [1] 293163 0
20/07/2015
Approval date [1] 293163 0
19/11/2015
Ethics approval number [1] 293163 0
15/1237H

Summary
Brief summary
Our extant research has indicated that intrapersonal factors (e.g., coping and thinking) are related to poor mental health in people with low vision. In this study, we will build on past trials in this area and examine the effectiveness of an adapted guided self-help programme on depressive symptoms. Our programme will include “third-wave” cognitive-and-behavioural treatment (CBT) components as a modern approach to treat the factors we found in our previous research. We will examine whether participants with low vision and depressive symptoms who receive the acceptance-focussed CBT programme show reduced depressive symptomatology (primary outcome), changes in coping, thinking, and quality-of-life (secondary outcomes) after the intervention compared to a treatment as usual group that includes a referral to the patients GP.
This project has two phases. Phase 1 involves conducting a pilot randomised-controlled trial (RCT) to determine the impact of the programme of interest. Phase 2 involves a participant evaluation of programme content, format, and delivery to guide further refinement.
The intervention will be conducted by Dr BA Sturrock who has substantial experience in both clinical and research intervention. She has trained practitioners in CBT intervention previously in a research setting and practices acceptance and commitment therapy (ACT) regularly in a private practice setting.
The guided self-help programme that we have adapted is made up of six modules designed to be used each week, in addition to three face-to-face visits and three telephone contacts of up to 50 minutes in duration. The six modules are: (1) Understanding emotional well-being in vision impairment, (2) Being present, (3) Doing what matters, (4) Opening up, (5) Effective communication, and (6) Wellness planning.
Following intervention, participant views will be gathered on the programme content, convenience, delivery, participant-therapist relationship, and impact.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58730 0
Dr Bonnie Sturrock
Address 58730 0
Centre for Eye Research Australia, 32 Gisborne St, East melbourne, VIC 3002
Country 58730 0
Australia
Phone 58730 0
+61 3 9929 8046
Fax 58730 0
Email 58730 0
[email protected]
Contact person for public queries
Name 58731 0
Bonnie Sturrock
Address 58731 0
Centre for Eye Research Australia, 32 Gisborne St, East melbourne, VIC 3002
Country 58731 0
Australia
Phone 58731 0
+61 3 9929 8046
Fax 58731 0
Email 58731 0
[email protected]
Contact person for scientific queries
Name 58732 0
Bonnie Sturrock
Address 58732 0
Centre for Eye Research Australia, 32 Gisborne St, East melbourne, VIC 3002
Country 58732 0
Australia
Phone 58732 0
+61 3 9929 8046
Fax 58732 0
Email 58732 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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