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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Acceptance and Commitment Therapy (ACT) can improve emotional well-being for individuals dealing with infertility. ACT encourages patients to accept their thoughts and feelings while committing to actions that align with their values. The trial aims to determine if ACT can reduce stress and enhance mood and relationship satisfaction for those affected by infertility. Individuals diagnosed with infertility who are not currently in therapy may be suitable candidates for this study. Participants will attend 12 therapy sessions, available in-person or virtually. As an unphased trial, this study offers a unique opportunity to explore a potentially beneficial therapy for emotional well-being during infertility.

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 prior data suggests that Acceptance and Commitment Therapy is safe for infertility patients?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe and well-received by individuals dealing with stress related to infertility. A small initial study found that a self-guided ACT program helped manage stress linked to infertility. Another study in North America successfully used ACT to support a couple facing infertility challenges.

These studies reported no serious side effects, suggesting that ACT can improve mental health and quality of life for those experiencing infertility. This is encouraging for anyone considering joining the ACT for Infertility trial, as the therapy has been successfully used in similar situations before. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for infertility because it offers a fresh approach compared to standard treatments like medication or invasive procedures. Unlike typical infertility treatments that focus on medical or physical interventions, ACT emphasizes psychological well-being and emotional resilience, helping individuals manage the stress and emotional challenges associated with infertility. This therapy is flexible, offering both in-person and virtual sessions, making it accessible and convenient for participants. By focusing on acceptance and mindfulness, ACT aims to improve mental health, which can indirectly support fertility outcomes.

What evidence suggests that Acceptance and Commitment Therapy might be an effective treatment for infertility-related distress?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial will receive, can help alleviate stress related to infertility. Some studies have found that ACT helps women cope better with stress and find more meaning in life when dealing with infertility. One study found that a self-guided ACT program effectively reduced stress linked to infertility. Another study showed that ACT helped a man significantly reduce his infertility-related stress. Overall, ACT appears promising for improving mental well-being in people facing infertility challenges. ^{1 6 7 8 9}

Who Is on the Research Team?

Rhonda M Merwin, Ph.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996141/

Acceptance and commitment therapy adapted for women with ... This acceptance and commitment therapy-based self-guided program proved to be an acceptable treatment for infertility-related distress.

2. link.springer.com link.springer.com/article/10.1007/s12144-023-05294-6

Mapping acceptance and commitment therapy outcomes in ... A systematic review of the literature was conducted to identify studies assessing Infertility and ACT. Empirical and quantitative studies were considered.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722910001628

Using Acceptance and Commitment Therapy to Treat ... The male participant reported significant decreases in sexual infertility stress. The study suggests that acceptance-based therapy shows promise in treating ...

4. brieflands.com brieflands.com/journals/mcj/articles/147911

Effectiveness of Acceptance and Commitment Therapy ... The results of this study revealed that ACT has been able to increase distress tolerance, flourishing, and purpose in life for infertile women ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05585242

Acceptance and Commitment Therapy (ACT) Adapted for ... This RCT will test the effect of a 7-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38576027/

a pilot study of the Infertility ACTion program This acceptance and commitment therapy-based self-guided program proved to be an acceptable treatment for infertility-related distress.

7. reproductive-health-journal.biomedcentral.com reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-024-01766-5

Acceptance and commitment therapy adapted for women with ... In North America, there has been one case study reporting success in using ACT in helping a distressed couple experiencing infertility [17].

8. researchgate.net researchgate.net/publication/376042814_Mapping_acceptance_and_commitment_therapy_outcomes_in_the_context_of_infertility_a_systematic_review

Mapping acceptance and commitment therapy outcomes in ... Since infertility is a relevant stressor, ACT was also expected to have a protective effect on the mental health of individuals with this ...

9. brieflands.com brieflands.com/journals/mcj/articles/147911.pdf

Effectiveness of Acceptance and Commitment Therapy ( ... Conclusions: Acceptance and commitment therapy appears to be helpful in improving psychological problems associated with infertility in ...