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The talk first study (Korero i te tuatahi when translated in to Maori): A comparison of the efficacy of Behavioural Activation (BA) compared to Sertraline (a medication) in the treatment of low mood.

A Randomised Controlled Trial comparing changes in the Patient Health Questionnaire Depression Scale (PHQ-8) scores after treatment with Behavioural Activation (BA) or Sertraline in patients with a low mood'.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000138886
Enrollment
102
Registered
2021-02-11
Start date
2021-03-01
Completion date
2021-05-28
Last updated
2021-02-16

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

Conditions

None listed

Brief summary

The study will be conducted using a 2-arm parallel group randomised controlled trial. Randomisation will be at the level of the individual patient. Depressed/low mood participants will be offered one of two interventions. One group will get the work/love/play assessment followed by behavioural activation to reverse the avoidance and escape behaviours, and the control group get sertraline antidepressant medication 50 mg tablet for the first week followed by 2 tablets daily for the subsequent 11 weeks. This study is aimed to see if offering a Behavioural Activation (e.g. exercise, catching up with friends, doing pleasurable activities) intervention is a effective or more effective than prescribing antidepressants to patients with low mood in primary care settings.

Interventions

The intervention is based on the work of Kirk Strosahl, who developed the therapy known as Focused Acceptance and Commitment Therapy (FACT) which is modified Acceptance and Commitment therapy for primary care. Each eligible intervention patient will get a work/love/play assessment (available from www.brucearroll.com free of charge) which checks on a 1 to 10 scale for how daily life (work, study etc.) is going, love as in friends, love as in intimates, love as in family and play (recreation hobbi

The intervention is based on the work of Kirk Strosahl, who developed the therapy known as Focused Acceptance and Commitment Therapy (FACT) which is modified Acceptance and Commitment therapy for primary care. Each eligible intervention patient will get a work/love/play assessment (available from www.brucearroll.com free of charge) which checks on a 1 to 10 scale for how daily life (work, study etc.) is going, love as in friends, love as in intimates, love as in family and play (recreation hobbies etc.). This will be done by the research assistant or one of the investigators on a one on one basis. There will also be open-ended questions on exercise, smoking, sleep, recreational drugs, alcohol, gambling issues in self or family, violence, citizenship/community involvement and if there is a spiritual/religious component to their lives and if they have any unresolved trauma. The purpose of this assessment is to determine the avoidance e.g. not seeing their friends or escape behaviours (e.g. excessive alcohol) and to reverse some or all of those behaviours. Motivational interviewing techniques will be used to reverse these behaviours and patients will be asked what they would be willing to change (based on their work love play responses) and then how likely on a scale of 1 to 10 they will do this in the next 1 -2 weeks. A score of 7 or more is required; otherwise the interviewer will renegotiate the activity until they get a score of 7 or more. The avoidance and escape behaviours will be used as a target for behavioural change using a task sheet for homework. This is a blank piece of paper on which the researcher writes "Task list" and asks the patient what they are willing to change (focusing on the behaviours and escapes that need reversing. Up to four behaviours will be recorded on the list and the score out of 10 for how likely they are to be done. The intervention will be done on the day of enrolment and face to face where possible. Where this is not possible, it will be done either by phone or by a later face to face appointment. The duration of the intervention will be about 10 minutes, with an additional 10 minutes to complete the study documentation forms and questionnaires. The interviews will be done in a GP clinic in a separate room. At two weeks and six weeks, a repeat of the intervention will be given to those who score ten or more on the PHQ 8 at those visits or in any patient who would like a further intervention. Fidelity to the intervention protocol will be done on 10% of participants via a consented recording.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Able to read and write English Understand the patient information sheet PHQ 8 greater than or equal to 10

Exclusion criteria

Received antidepressant medication in the past 8 weeks Suffer from severe psychiatric disorders or substance abuse any medication contraindicated with sertraline or allergies to sertraline Pregnant or postnatal women PHQ 8 greater than or equal to 21 (max score 24) GAD 7 greater than or equal to 18 (max score 21) bleeding disorders, severe liver disease or arrhythmias currently taking antispsychotic medication currently seeing a psychologist or waitlisted to see one or doing online psychotherapy patients GP not keen on them being in the study current suicidal plans

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026