The preparation phase of therapy involves three stages: establishing a therapeutic alliance; creating a safe psychological and physical space; and participant preparation. While the content and process of each of these stages is woven in each interaction with the participant, the foundation is laid during the two ninety- minute introductory sessions with the therapists.

3.1 Stage One: Establishing a Therapeutic Alliance, Gathering Information, Participant Orientation

3.1.1 Establishing a Therapeutic Alliance
The first stage of the preparation phase provides adequate time in non-drug therapy sessions to establish a safe and positive therapeutic alliance, which is an absolute prerequisite for treatment (Johnson, 1996). The participant must feel assured that his/her well-being will be attended to with utmost care in order to gain the most benefit from the MDMA session. The therapists introduce themselves and explain how they became interested in this work and describe as their experience in treating PTSD. This reinforces the therapists' experience and commitment to support the participant throughout the process. Greer and Tolbert (1998) note that self-disclosure on the part of the therapist creates a context for collaboration, intimacy, and trust. It also can give the participant a sense of shared identification with the therapists, which can increase personal comfort as the participant enters a state of heightened vulnerability.

Participant: "With all the PTSD that's got to be out there ... I was so afraid to admit how I feel. I felt like I was the only one."

Therapist: "You are not in that position any more."

Participant: "No one really listened to how I was feeling. They just wanted to give me another prescription."

Therapist: "Anything else that comes up for you, thoughts ... feelings?"

Participant: "I've been feeling nervous, anxious, not sleeping well. I know a part of it is being free of the antidepressant. I am agitated, short-tempered." (Sniffing)

Therapist: "Let's practice the abdominal breathing. This is one method to help you be with your feelings and let them inform you of what is going on inside of you."

Participant: (Inhalation/ Exhalation)

Therapist: "In some ways the process begins before we actually begin. It's begins ahead of time, as you set the intention to do it. And as you get closer, these feelings are natural. It is not easy. In some ways your psyche is already making use of what you decided to do."

Participant: "It helps to understand. I am willing to try anything. Hell, I was in therapy every week for a whole year and never really addressed my symptoms."

3.1.2 Gathering Information
The therapists ask open-ended questions, provide some feedback to the participant about the results of his/her psychological testing and medical evaluation, and encourage the participant to share what he/she believes is personally significant information.

Therapist: "We don't have all the results from your tests, but we spoke with the doctor and all the results so far tell us that you meet the criteria for this treatment. Let's start with any thoughts or questions that may have come up for you."

Participant: "The session with Dr. Wagner was good. I can see where it is starting to open up a can of worms. The process is already starting with me. Part of me is very excited,and part is very skeptical, like `uh oh, is this really what I need to be focusing on.' There was a question on the PTSD scale where Dr. Wagner asked if I had dreams. I said `no,'then it dawned on me. I don't have dreams about my father actually doing whatever he did, but I have dreams about my mother. She never really worried about what he was doing or how he was abusing us or how he was abusing her. She would worry whether the fallout from Chernobyl got into my Mars candy bar and I got nuclear poisoning. She worries about things that are completely out of control. And she goes on and on in our conversations and we are "close." But I realize that I do dream about her. Just the other night I had a dream about how we were talking on the phone. And in this particular dream the light was white and she went into her normal, `I'm worried about this, I'm worried about where you are living, without actually helping, cuz she wants to help, but my father won't let her help even though she makes all the money. And, um, the phone just came unplugged from the wall and I thought it was really interesting that ... and then my first instinct was to plug it back in and call her back. And so I started thinking about that because it was right after the testing."

Therapist: "MMMmmm"

Participant: "And I said (to Dr. Wagner), `No, I don't have dreams about this and then how I continuously have dreams about her. He's not in the dreams, but she's in the dreams. And how she's not this kind, compassionate mother like she used to be. How she's changed. It's really interesting. I've tried to resolve my anger towards her. And I think it is harder now that I have a child. To think, `I don't care who you are or how much I love you or how dependent I am on you, I'm going to take my child away from you. You know I wouldn't even let my child in the room with people who even think like that, except that I do let him go with my father knowing ... so it's kind of a ... so it's interesting that the process is already starting to work even though I haven't had any therapy." (Laughs)

Therapist: "Well that is typical."

Therapist: "Yes, the screening does tend to stir things up for a lot of people. And also as you were saying, the intention to do this work also sets your psyche in motion about it, from the time that you decide that you are going to do it. I think it is an important question that you bring up ... `Is this the time that I can be focusing on this or do I need to focus on day to day life?' What's your feeling about that now?

Participant: "Well, I vacillate, but I figure that this is an opportunity for my day-to-day life to get better ... or not. At least it's an opportunity that doesn't come across your path every day. I am a school counselor by profession; I'm in no state to actually be a school counselor. So I consciously or subconsciously cannot go and pursue jobs because I know there are things I need to work on my self. So I think this is the time to do it ... even if it is hard."

The therapists guide these interviews to gather information about the participant's present symptoms, event(s) that caused the PTSD, previous treatment and outcome, other psychiatric history, and medical, social and family history.

Therapist: "We'd like to talk in more detail about the sessions and we'd also like to hear more detail about your history and the trauma in particular. We can do that in any order you want. Do you feel like talking more about your self and your trauma now or would you like to hear about the sessions?." The therapists also discuss with the participant his/her previous experiences with MDMA, psychedelic drug use, or other non-ordinary states of consciousness. During this interaction the therapists must collect enough information for a sound understanding of the participant. This interaction is also an opportunity for the therapists to address any concerns the participant may have about his/her treatment.

3.1.3 Participant Orientation
In this stage, the therapists orient the participant to the therapeutic process. The therapists talk about the scope of the MDMA session. They discuss the participant's expectations, motivations, purpose, and intentions for the therapy sessions. The therapists may liken the effect of the MDMA to an opportunity to step inside a safe container in which it will be easier to remain present with his/her intrapsychic material. The participant should be encouraged to cultivate an attitude of trust in the wisdom and timing of the inner healing process that is catalyzed by this approach.

The therapists work to clarify the participant's expectations and intentions and encourage an attitude of openness toward the MDMA-facilitated experience in whatever way it unfolds. The therapists explain that often the deepest, most effective healing experiences take a course that is quite different from the one predicted by the participant's rational mind. Participants are encouraged to welcome difficult emotions rather than to suppress them, in order to better resolve deep-seated patterns of fear and powerlessness. The therapists also remind the participant to be open to experiencing, understanding, and achieving relief from his/her PTSD symptoms and the underlying trauma as part of the therapeutic goal. The therapists emphasize their commitment to help the participant cope with and recover from all the emotional material that may arise during the session. They agree to provide support, safety, and guidance for the participant in working with whatever emotions and memories arise.

Therapist: "We want to emphasize our commitment to you and to be available for you. It is a privilege to support you as you do this work."

Therapist: "If you decide you need to be on an antidepressant you can do that. You are always free to change your mind. What's most important is your well being."

Participant: "I think after experiencing 4 of 5 life stressors, like losing my job, typically I would say I need to go on an antidepressant. But because of the study, I am excited because I am also faced with working through this without being on anything. I think that I am cognitively aware enough to know that if I really feel like I'm slipping I would be able to let you know or ask for it." It is absolutely essential that the therapists use clinical judgment and personal awareness to ascertain when to facilitate the participant's process vs when to silently witness the participant's experience, as explained in more detail in Stage Three. The participant is encouraged to request support from the therapists during times of intense emotion or painful memories. Such support can take the form of being touched or held, receiving reassurance, or simply talking about what they are experiencing.

Therapist: "We want to reaffirm our commitment to be present for you. We will make this a safe place for you to have whatever experience comes up. If difficult things come up try to stay with them and fully experience them and use your breath to move into them. And ask us for anything you need. We'll weave alternating periods of going inside, using eye shades, listening to music if you want to and then talking to us when you feel like it.

Therapist: "Sometimes if we've been talking for a while we may suggest you bring your attention inside or you may just get the sense that you need to do this." Ideally during the second introductory session the participant is introduced to the attendant who will accompany him or her during their overnight stay at the clinic. While this may not always be possible, such a meeting helps the participants feel more comfortable and familiar with the attendant. If necessary, the participant could meet the attendant on the day of the MDMA session. The attendant is a registered nurse (RN), always be of the same sex as the participant. The RNs are trained by the therapist in how to appropriately fill this role. These nurses are selected for their ability to act as reliable and compassionate attendants, and to recognize when to call the therapists in the event that the participant is experiencing physical or emotional distress the night after an experimental session. These individuals must be able to be present with other people's emotions without becoming emotionally reactive themselves.

Attendants see to the participant's need for food or liquids, and offer companionship by sitting or taking a walk with them, according to the participant's desires. They are instructed to listen compassionately if the participant wants to talk, but not to interpret the participant's experiences or otherwise act as therapists. The emphasis is on listening and being quietly present rather than talking. Accordingly, the attendant avoids initiating long conversations with the participant or being intrusive in any way on the participant's experience, other than to inquire about their comfort or their physical or emotional needs.

3.2 Creating a Safe Psychological and Physical Space

Establishing a safe setting for the participant requires that the therapists take an active role in creating an environment that is conducive to the full range of the MDMA therapeutic experience. A safe physical and psychological space allows and encourages the participant to attend to his/her internal stimuli. The setting as a whole is designed to minimize the impact of external stimuli and to support the participant's attention to his/her intrapsychic process. The therapists create a favorable setting in two basic ways: by establishing a contract with the participant, as outlined below, and by attending to several physical details of the setting. For instance, the participant should be able to recline comfortably in a setting devoid of any unfavorable distractions (free of all objects that could have powerful negative or disturbing connotations). While the research setting should be as supportive as possible, the participant should be aware of all safety measures in place to respond to the unlikely possibility of a medical complication. The participant is provided with eye shades and a pre-selected program of music. Music for the drug session is selected on the basis of its ability to elicit emotional responses or to facilitate a sense of passage or transformation. Music is chosen to support emotional experience while minimizing suggestion, with music containing lyrics generally avoided (Grof, 2000). The participant has the option to request periods of silence and the therapist has the option to forgo sections of the musical program. Participants may also elect to forgo eyeshades.

To create the safest possible psychological space, the therapist and participant discuss the parameters of each session and make several specific agreements, including:

1. The participant, accompanied by a trained attendant, agrees to remain overnight in the clinic or office. The participant is permitted to have his/her significant other spend the night unless contraindicated by the clinicians.
2. The participant agrees to have a prearranged ride home the following morning.
3. At least one of the therapists is present at all times during the entire MDMA session.
4. The participant and therapist discuss the possibility of physical contact with the participant in the form of focused bodywork and nurturing touch is discussed. The therapists assure the participant that at no time will they engage in any form of sexual contact. The participant is invited to ask for nurturing touch, (holding of a hand or being held). The participant is also instructed to use the word "stop" as a specific command if the therapists are doing anything the participant wants them to discontinue. The therapists agree to always respond to this command except when such action is necessary for the participant's safety.
5. The participant agrees to refrain from self-harm, harm to others, and harm to property. If, in the judgment of the therapists, the participant is engaged in any dangerous behavior, the participant complies with the therapists request to stop according to the terms of this agreement. The participant understands that failure to respond to the request may require an appropriate level of intervention.

To enhance further the safety of the psychological space, the participant and therapists address any fears the participant may have, no matter how trivial or catastrophic. The therapists collaborate with the participant to develop strategies that will increase the participant's feeling of safety.

Therapist: "What is on your mind since our last session? Any questions or thoughts?"

Participant: "I've been through a gamut of emotions, nervous, anxious and not sleeping well. I just don't feel rested, dragging myself out of bed. I'm real tired."

Therapist: "Do you have an idea about what the anxiety is about?"

Participant: "I think it is about the upcoming study. I really can't think of anything else. It's the unexpected. I am not good at surprises. I want to know what's coming from one day to the next."

Therapist: (Long silence.)

Participant: (Crying) "It scares me."

Therapist: "Can you say more about what scares you?"

Participant: "I am afraid I'll be a different person. What if I get rid of all of this and Tom won't love me anymore? What if I'm not the person he fell in love with? He reassured me that this was silly. But I have been like this for so long. Who am I? What if I am not really a person? What if? What if? I can come up with a thousand rationales for why I am like this."

Therapist: "That is a real issue; however, in reality you'll be more deeply yourself. You'll be reconnected with yourself in a deeper way."

Therapist: "One thing you said earlier was that you wanted to run off and hide. Maybe you lost part of yourself, a part of you disappeared."

Participant: "I think there was a lot of me that disappeared."

Therapist: "So this might be an answer without having to run away. You may find that you become more deeply yourself. You are willing to do this and face it."

The participant is aware that he/she will be in a heightened state of vulnerability and will likely experience a range of emotions, thoughts, and physical sensations. The therapists discuss the process of helping the participant gain relief from difficult, intense emotions or distressing thoughts and remind the participant that he/she is in a safe environment and under the care of experienced clinicians. The participants are taught diaphragmatic breathing techniques to aid in the relaxation and self-soothing process. They are encouraged to use their awareness of the breath as a technique for staying present with experiences, especially difficult experiences from which they might otherwise attempt to distance themselves.

Another important aspect of developing a psychologically and physically safe space involves a joint exploration of the members of the social support system surrounding the participant. Before any MDMA- assisted treatment session, the therapists and participant may consider ways in which the members of his/her social support network can help the participant during the time between therapy sessions. The therapists should explain the potential value of sharing knowledge about the treatment sessions with selected members of the participant's social support system. The participant may choose to invite a significant other (friend, family member or partner) to spend time with them at the close of at least one MDMA session. This can be a valuable experience that enhances the supportive relationship. It should be cleared in advance with the therapists based on the same clinical judgment they would use in considering the therapeutic value of an overnight stay by a significant other.

Maintaining a safe physical space includes providing access to treatment for possible reactions to the medicine during or immediately after each treatment session. Most reactions can be dealt with through supportive care, but some, such as hypertensive reaction, may need additional intervention. MDMA- assisted psychotherapy should be done in a setting where Advanced Cardiac Life Support (ACLS) is rapidly available in the unlikely event of an acute cardiovascular complication. The clinic or office should have means of readily assessing blood pressure and heart rate or pulse during the MDMA session. When providing beverages, the therapists should ensure that participants do not consume over 3 L over the course of the MDMA session, and they may wish to provide electrolyte-containing beverages (such as Gatorade) instead of water as a means of reducing risk of hyponatremia. Therapists should make contingency plans for responding to other unlikely events. In this early pilot study, the therapists are prepared to treat a number of unlikely adverse events, and they will have an emergency medicine physician and nurse present for five hours after drug administration.

3.3 Therapist Preparation

In addition to standard training in the psychotherapeutic treatment of PTSD, therapists substantially benefit from personal experience with non-ordinary states of consciousness. Ideally this includes personal experience with MDMA in a therapeutic setting. If this is not possible, a series of Holotropic BreathworkTM sessions (a non-drug method that activates a similar therapeutic process) would also be beneficial (Grof, 2000).

This personal experience is important because it:

• Increases the therapist's level of comfort with intense emotional experience and its expression.
• Provides first-hand validation of and trust in the intelligence of the therapeutic process as it arises from an individual's psyche.
• Familiarizes the therapist with the terrain and flavor of non-ordinary states of consciousness. This can be invaluable to the therapist's effort to understand and empathize with the participant's experience, especially features that might be most helpful or unsettling.
• Provides the therapist with an intrapersonal working knowledge of the integration process related to this therapeutic approach.
• Enhances the credibility of the therapist ­ the participant's sense of security and treatment alliance deepens with understanding that the therapist has had a similar kind of experience.

During MDMA sessions, the therapists enlist the medicine's qualities to enhance the therapeutic experience. The therapists respect the medicine's "apparent facility in inducing heightened states of empathic rapport" (Grob et al, 1996, p. 103) and operate within the previously discussed ethical guidelines and established parameters of treatment. The therapists remain mindful of their own mental set vis a vis this therapy, especially their own beliefs related to the use of MDMA as an adjunct to therapy.