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Does an acceptance-focussed guided self-help programme reduce depressive symptoms in patients with vision impairment?

Does an acceptance-focussed guided self-help programme reduce depressive symptoms in patients with vision impairment? A pilot randomised controlled trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000816550
Enrollment
80
Registered
2015-08-07
Start date
2016-04-12
Completion date
2017-12-21
Last updated
2020-01-13

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

Conditions

None listed

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.

Interventions

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 pr

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.

Sponsors

Centre for Eye Research Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026