7019AHS Clinical Research

Introduction

I am the lead researcher of a research team, working for. We are conducting a Randomized Control Trial that is aimed to study and compare the efficacies of two forms of treatment for depression, viz. Cognitive Behavior Therapy and administration of Anti-Depressants. The trial will consist of 200 participants, and will continue for 3 months, to analyse which treatment shows as being more effective. We would like you hereby invited to participate in this study. Please note that you may contact me or anyone from the research team if you have any questions regarding the research, and you can go through the details provided in this information sheet to decide if you would like to participate in this. You do not have to make your decision today whether you would like to participate, and your correspondence is always welcome, if you have any doubts regarding the trial. There might be certain technical aspects you might have difficulty understanding, in which care I you are more than welcome to revert to me, and I shall try my best to explain it to you.

Purpose of the research

Depression is a common mental health condition that affects more than 300 million people from all age groups around the world. It is one of the leading causes of disability globally and a major contributor to the overall burden of the disease (who.int, 2018). Different treatments exists for depression such as psychological and pharmacological interventions (Li, 2018). The aim of our study is to compare one psychological intervention (Cognitive Behavior Therapy) with a pharmacological intervention (Anti-depressants) to find out which strategy is more effective. Results from this trial can be used to inform clinical decisions in the treatment of Depression.

Type of Research Intervention

This research will involve a randomized control trial where the participants will be divided into two groups. One group will be receiving Cognitive Behaviour Therapy and the other group will be administered Anti Depressants (Selective Serotonin Reuptake Inhibitors). The trial will last for 3 months, in which the participants will be administered either antidepressants (regularly) or will undergo Cognitive Behaviour Therapy (in sessions). At the end of the trial the participants will be re assessed for depressive symptoms to understand if the effect of the treatments.

Participant Selection

We are inviting all adults diagnosed with depression, and tested positive on PHQ 9 (which is a depression test questionnaire that is filled by the participants). The contacts were collected from the General Physician referrals from the clinic.

Voluntary Participation

Kindly note that your participation in this trial is completely voluntary, and the decision to participate in this or not is entirely yours. Also, the services available for you in this clinic will remain unaffected by your decision whether you would like to participate or not. If you do not wish to participate, you would receive the routine treatment offered in this clinic, and we shall inform you more about the treatment in due course. You are also free to change your decision to participate during the period of the trial, and withdraw from it at any point of time. Also note that you do not have to take part in the trial, if you do not wish to. If you have any questions, doubts, concerns or feedback or complaints about the trial, you can get in touch with me or any member of the research team.

Information on Trial Drug

The trial drug being tested in this research is a Selective Serotonin Reuptake Inhibitor (SRI) called Fluoxetine or Prozac, which is a commonly prescribed medicine for depression. The medicine have been tested before with other antidepressants, however their efficacy have not been tested against psychological therapy like Cognitive Behavior Therapy. This will be a phase 3 trial.

Prozac is manufactured by Eli Lilly and Company, and can cause few side effects such as nausea, stomach upset, headache, constipation, anxiety, drowsiness, insomnia, nervousness, dizziness, heart palpitation, loss of appetite, symptoms of cold, impotency, loss of sexual drive, and difficulty in having orgasms.

Half of the participants will be administered this medicine, while the other half will be given placebo tablets.

Procedures and Protocol

A. Unfamiliar Procedures:

1. Randomization and Blinding

Since we do not know whether cognitive behavior therapy works better than Prozac, we need to compare the two. In order to achieve this, we will divide the participants in 2 groups. The participants will be selected randomly in the two groups. Participants in group one will be given Cognitive Behaviour therapy through counseling sessions that will focus to improve the thought processes of the participants, and placebo medication, while the group two will be administered Prozac. The trial will be single blinded, that is the participants will be unaware of whether they are in group one or group two, however the research team will be aware of it. At the end of the trial, all the participants will be debriefed.

2. Involving Drug and Placebo

The drug selected for the trial is Prozac, and a placebo that looks like Prozac tablets (but contains sugar pills).

3. Rescue medication

If Prozac does not show the desirable effect, Sertaline or Zoloft will be used as a rescue medication.

4. Treatment policy

You will receive treatment for depression according to the national guidelines, which means you will undergo counseling and psychotherapy sessions with a psychologist and will be given medications.

B. Description of the Process

In the first visit, you will be asked to fill up a PHQ-9 form, which is a questionnaire. This will help to understand the extent of the depressive symptoms experienced by you. After which you will be assigned to one of the two groups. Based on the group, you will either undergoes Cognitive Behaviour Therapy with a psychologist, who will help you to identify the behavioural factors which causes depression, and help you to improve those thought processes, and thus reduce depressive symptoms. Additionally placebo medications will be provided. Alternatively you might also be given only Prozac (everyday). The trial will last for 3 months, at the end of which everyone will be asked to fill up the PHQ 9 questionnaire again, to identify whether there have been any improvement in the condition among all participants.

Duration

The study will be conducted for 3 months.

Side Effects

As previously informed, that some unwanted side effects might occur due to Prozac, however the group receiving cognitive behavior therapy would be at no risk of adverse side effects. Will closely monitor the onset of any side effects, and would also use additional medications to reduce their risks. At all points we will keep you updated on the treatment, and your participation will continue based upon your decision.

Risks

The trial does not entail any risks for you. If Prozac or Cognitive Behavior Therapy does not work, and your depressive symptoms persist after a week of treatment, you will automatically be moved out of the trial and given alternative treatment, to ensure fastest effect.

Benefits

The benefit for participating in this trial is that your treatment will be covered for free, and if you fall sick within the trial, its treatment will also be covered by us. Also through your participation we might be able to discover whether Prozac is more effective than CBT, a finding that can help the wider society.

Reimbursements

We will provide you money for travelling and parking and also reimbursement for lost work time. You will not be given any additional money or gifts for participation.

Confidentiality

Identity of the participants will be kept confidential from the general public at all points of time. Data from the research will also be confidential, and accessible only be the research team. We will use numbers instead of names to identify the participants, thereby ensuring confidentiality of records. Access to this data will be available only to the research team and the sponsors.

Sharing the results

The information gathered from the study will be regularly shared with you during the meetings before it is shared with the public. Confidential and personal information will not be shared. Crucial data will firse be dessiminated to all participants in meetings, after which it will be shared with public.

Right to refuse or withdraw

Participation in the trial is completely voluntary, and will not affect your treatment in any manner. Even if you do not wish to participate, you will still get all the benefits from the clinic that you would otherwise have. At any point of time, you can choose to stop participating and that will not affect your rights as a patient in this clinic. Your treatment wil remain unaffected.

Alternatives to participating

If you do not wish to participate in the trial, you will be provided the standard treatment that is practiced in this clinic.

Who to contact

If you have any questions, you can ask any of the researchers or me now or at any point of the study in the period of 3 months. You may contact any of the following personnel:

Certificate of Consent

I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction.  I consent voluntarily to participate as a participant in this research.

Print Name of Participant__________________                                                      

Signature of Participant ___________________

Date ___________________________

Day/month/year                     

Statement by the researcher/person taking consent

I  have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

1. Participants will be divided into two groups and provided treatment for depression: one group will receive cognitive behavior therapy and the other group will revieve pharmacotherapy (Prozac).
2. Selection in the two groups will be randomised
3. Placebo medication will be used, and the participants will not be aware if they are receiving Prozac or placebo.

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

A copy of this ICF has been provided to the participant.

Print Name of Researcher/person taking the consent________________________                                               

Signature of Researcher /person taking the consent__________________________

Date ___________________________                                

Day/month/year

Centre Number:         

Study Number:

Patient Identification Number for this trial:

Consent Form

Title of Project:

Name of Researche

Please initial all boxes

I confirm that I have read and understand the information sheet dated_____ for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.

I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected.

I understand that relevant sections of my medical notes and data collected during the study,may be looked at by individuals from [COMPANY NAME], from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research.  I give permission for theseindividuals to have access to my records.

I agree to my GP being informed of my participation in the study.  

I agree to take part in the above study.                                

Name of Participant                            Date                                        Signature

Name of Person                                  Date                                        Signature

taking consent.          

References

Li, J. (2018). Effect of Psychological Care Combined with Prozac on Patients with Post-Stroke Depression. Journal of Nursing, 5(4), 1-3.

who.int (2018), Depression, retrieved on 13 June, 2018, from: https://www.who.int/news-room/fact-sheets/detail/depression