ACT for Infertility

Overseen By Julia Woodward, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Suicidality, Psychosis, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

9 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for infertility?

Research shows that Acceptance and Commitment Therapy (ACT) can improve mental health and quality of life in infertile couples, which are important factors when dealing with infertility. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

The provided research articles do not contain specific safety data for Acceptance and Commitment Therapy (ACT) for infertility or other conditions. ^{6 7 8 9 10}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for infertility?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on improving mental health and quality of life by helping individuals accept their thoughts and feelings rather than trying to change them, which can be particularly beneficial for infertile couples dealing with emotional distress. ^{1 2 4 11 12}

What is the purpose of this trial?

In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT.

Research Team

Rhonda M Merwin, Ph.D.

Principal Investigator

Duke University

Eligibility Criteria

This trial is for up to 10 individuals experiencing infertility and related psychological distress, such as depression or anxiety. Participants will engage in a therapy program called Acceptance and Commitment Therapy (ACT) for 12 sessions to see if it helps improve their emotional well-being.

Inclusion Criteria

Patients must not be already participating in individual therapy

Patients must have a diagnosis of infertility

Exclusion Criteria

Patients with current substance use

Patients endorsing current suicidality and/or self-harming behavior

Patients with current psychosis symptoms

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of Acceptance and Commitment Therapy (ACT) targeting infertility-related distress

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in mood, stress, and ACT processes after treatment

4 weeks

Treatment Details

Interventions

• Acceptance and Commitment Therapy

Trial Overview The study tests the effectiveness of Acceptance and Commitment Therapy (ACT), which includes 12 therapy sessions aimed at reducing psychological distress in people dealing with infertility. The goal is to assess whether ACT can enhance mood, reduce stress, and increase psychological flexibility.

Participant Groups

Group I: Acceptance and Commitment Therapy Experimental Treatment 1 Intervention

For those that enroll in the study, the therapist will see patients for 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. The therapist will offer both in-person and virtual sessions.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Counseling based on Acceptance and Commitment Therapy (ACT) significantly improved mental health and quality of life in infertile couples, as shown in a randomized controlled trial with 54 participants who received 8 weekly sessions.

One month after the intervention, couples in the ACT counseling group reported a notable decrease in mental health issues and an increase in quality of life compared to the control group, indicating that ACT can be a beneficial support for those facing infertility challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of counseling based on acceptance and commitment therapy on mental health and quality of life among infertile couples: A randomized controlled trial. Hosseinpanahi, M., Mirghafourvand, M., Farshbaf-Khalili, A., et al.[2020]

Psychosocial interventions, especially cognitive-behavioral therapy (CBT), significantly improve clinical pregnancy rates for couples undergoing assisted reproductive technology (ART), with a risk ratio of 2.01, indicating they are twice as likely to achieve pregnancy compared to those not receiving such interventions.

These interventions also effectively reduce psychological distress, with a moderate effect size (Hedges g=0.59), particularly benefiting women more than men in terms of reducing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a systematic review and meta-analysis. Frederiksen, Y., Farver-Vestergaard, I., Skovgård, NG., et al.[2022]

Psychological interventions for infertile patients did not significantly improve mental health outcomes, such as depression and anxiety, based on a meta-analysis of 21 controlled studies.

However, these interventions were associated with a 42% increased likelihood of pregnancy, particularly benefiting couples not undergoing assisted reproductive treatments (ART).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of psychological interventions for infertile patients: a meta-analysis examining mental health and pregnancy rate. Hämmerli, K., Znoj, H., Barth, J.[2022]

A study of 589 infertile women undergoing assisted reproductive technologies (ART) revealed that 58.9% experienced non-psychotic mental disorders, primarily anxiety, and 18.34% had significant sexual dysfunctions, particularly low libido.

There was a strong link between sexual dysfunctions and mental health issues, with 100% of women with sexual disorders also having borderline mental disorders, highlighting the need for integrated therapeutic approaches to improve both sexual health and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychopathological characterisitic of infertile women with sexual dysfunctions in assister reproductive technologies programs]. Stenyaeva, NN., Chritinin, DF., Chausov, AA., et al.[2019]

A 10-week group behavioral treatment program for 52 infertile women led to significant psychological improvements, including reduced anxiety and depression, as measured by validated psychological instruments.

The results showed statistically significant decreases in various negative psychological symptoms, indicating that behavioral treatment can be an effective intervention for improving mental health in women undergoing infertility treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological improvement in infertile women after behavioral treatment: a replication. Domar, AD., Zuttermeister, PC., Seibel, M., et al.[2017]

Individuals undergoing infertility treatments generally cope well, but those experiencing miscarriages or prolonged time to pregnancy may face a decreased quality of life.

Women report higher levels of anxiety and depression during treatment compared to men, highlighting the need for psychological support to address emotional strains and potential marital issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological aspects of infertility]. Järvholm, S.[2023]

A pilot survey of infertility specialists revealed that most programs lack formal policies for denying treatment based on psychological grounds, although informal criteria do exist.

Four major 'red flags' for treatment rejection were identified: substance abuse, physical abuse, severe marital strife, and coercion, with stricter criteria applied depending on the type of infertility intervention requested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening in or out of the new reproductive options: who decides and why. Leiblum, SR., Williams, E.[2004]

Infertility is a significant emotional crisis for couples, leading to feelings of loss in various aspects of life, and while Assisted Reproductive Technologies (ART) offer hope, they also impose substantial emotional and financial burdens.

Couples often overlook or are unaware of the potential medical risks and psychological consequences associated with ART, highlighting the need for healthcare professionals to provide comprehensive information to help couples make informed decisions about their fertility treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychosocial aspects of the direct path from infertility to the "instant family": are all risks known]. Baor, L., Blickstein, I.[2006]

The primary risk associated with assisted reproductive technologies (ART) is multiple pregnancies, which can lead to complications, highlighting the need for strategies to reduce this risk, although single-embryo transfer isn't suitable for all cases.

While children conceived through ART may have slightly poorer perinatal outcomes compared to those conceived naturally, the overall risk remains low, as the majority of ART pregnancies and births are normal, suggesting that any excess risk is relatively small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the risks of the assisted reproductive technologies (ART) and how can they be minimized? Rebar, RW.[2020]

Infertility and its treatments can lead to significant mental health issues, with women experiencing increased depressive symptoms and men showing more negative emotional responses.

The study highlights the need for integrating mental health professionals into fertility clinics in Denmark to address the psychosocial impacts of infertility and ensure comprehensive care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The psychosocial consequences of infertility and fertility treatment]. Schmidt, L., Sejbæk, CS.[2012]

In a study of 35 couples dealing with infertility, women showed that higher neuroticism was linked to increased stress related to infertility, while depression affected their social and relational stress aspects.

Despite the emotional challenges, both men and women in the study generally exhibited low levels of anxiety, depression, and stress, suggesting that psychological intervention may not always be necessary for couples coping with infertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personality and emotional adjustment in infertility. Lopes, VM., Leal, IM.[2012]

Supportive therapy for infertility patients focuses on improving mental well-being by addressing feelings of guilt, enhancing self-esteem, and providing empathetic interventions that promote optimism and problem-solving.

As the demand for infertility treatment increases, the need for skilled mental health clinicians who understand both the psychological aspects of infertility and the related medical technologies is also rising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infertility: psychotherapeutic issues. Rosenthal, MB.[2019]

References

1. India pubmed.ncbi.nlm.nih.gov

The effect of counseling based on acceptance and commitment therapy on mental health and quality of life among infertile couples: A randomized controlled trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a systematic review and meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The efficacy of psychological interventions for infertile patients: a meta-analysis examining mental health and pregnancy rate. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Psychopathological characterisitic of infertile women with sexual dysfunctions in assister reproductive technologies programs]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Psychological improvement in infertile women after behavioral treatment: a replication. [2017]

6. Sweden pubmed.ncbi.nlm.nih.gov

[Psychological aspects of infertility]. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Screening in or out of the new reproductive options: who decides and why. [2004]

8. Israel pubmed.ncbi.nlm.nih.gov

[Psychosocial aspects of the direct path from infertility to the "instant family": are all risks known]. [2006]

9. Japan pubmed.ncbi.nlm.nih.gov

What are the risks of the assisted reproductive technologies (ART) and how can they be minimized? [2020]

10. Denmark pubmed.ncbi.nlm.nih.gov

[The psychosocial consequences of infertility and fertility treatment]. [2012]

11. United States pubmed.ncbi.nlm.nih.gov

Personality and emotional adjustment in infertility. [2012]

12. United States pubmed.ncbi.nlm.nih.gov

Infertility: psychotherapeutic issues. [2019]