1 Kronprinzenstr. 14, 65185 Wiesbaden and 2 Institute for Medical Psychology, Friedrich-Schiller-University, Stoystr. 3, 07740 Jena, Germany
3 To whom correspondence should be addressed. Email: theresedeliz{at}aol.com
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Abstract |
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Key words: infertility/IVF/meta-analysis/psychotherapy
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Introduction |
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Without prior knowledge of the Boivin (2003) study, the authors of this paper independently sought to supply evidence of the efficacy of psychological interventions for infertility patients in an earlier, larger scale unpublished thesis. This paper introduces an extract from this work. In comparison to the Boivin (2003)
systematic review, the aim of this study was to provide a meta-analytic review of the available statistical evidence for the efficacy of psychotherapy on infertile patients. Commencing with an expansive search for studies, the following questions were investigated: do group and individual/couple psychotherapies for infertile patients (i) reduce anxiety and depression and/or (ii) possibly promote pregnancy in infertile women?
Special attention will be given to group and individual/couple psychotherapy administered within the realm of the medical treatment regimen. Past research on differences between group and individual/couple therapies has shown both types to be of similar effectiveness when compared to each other (McRoberts et al., 1998), and that psychotherapy is significantly more effective than no treatment or minimal treatments for a variety of disorders (Smith et al., 1980
; Fuhriman and Burlingame, 1994a
,b
; Lambert and Bergin, 1994
; Lipsey and Wilson, 1993
).
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Materials and methods |
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Statistical analysis
The meta-analyses were carried out according to Lipsey and Wilson (2001) by generating (independent) sets of effect sizes (ES), testing for homogeneity of distribution and investigating sources of variance using a Fixed Effects Model (Hedges, 1994
; Hedges and Vevea, 1996
; Overton, 1998
). ES denote the strength and magnitude of psychotherapy or other interventions on patients and correspond to the widely used convention for the magnitude of effect sizes, i.e. small: ES
0.20; medium: ES=0.50; large: ES
0.80 (Cohen, 1977
, 1988
). Accordingly, SE and weighted inverse variance weights (WE) were computed to control for potential influences caused by uneven sample sizes.
In order to maximize the potential computing advantage from the study pool, two different statistical formulas were computed. First, for the reduction of anxiety and depression, the pre-post contrast effect size statistic is used to compare the central tendency on a variable measured at one point in time (t1) with the central tendency of the same variable measured at a later point in time (t2). This standardized mean gain statistic standardizes differences between samples and aims to examine change (Becker, 1988).
Secondly, the possible effect of psychotherapy on conception may be described as a one-variable relationship and measured as the proportion effect size statistic. This central tendency statistic denotes the amount of a sample that reportedly became pregnant following psychotherapy treatment. Its values range from 0.0 to 1.00 and it provides an estimate for the mean proportion across studies. In order to avoid compression of the SE when a proportion nears 0 or 1, the logit method was chosen for value flexibility (Lipsey and Wilson, 2001). However, for ease of interpretation, logit values are transformed back to proportion ES in a final step. The rate of reported pregnancies was further differentiated between treatment and control groups.
The Q-test screens the computed ES for homogeneity. This test is based on the Q-statistic, distributed as a 2 with k1 degrees of freedom (k=number of ES) (Hedges and Olkin, 1985
). We assume that an effect size observed in a study estimates a so-called population effect while containing sampling error. Therefore, a homogeneous distribution implies that the dispersion of ES around their mean is no greater than expected from sampling error alone (H0). However, significant results denote that the variability of ES around their mean is larger than would be expected from sampling error alone. The ES are heterogeneous and the variability may be spawned by other (unknown) sources of variance (H1). Excess variability can be explained by showing that it is associated with moderator variables that systematically differentiate studies with larger and smaller ES. If differences in ES are associated with moderator variables, what remains will only be subject level sampling error.
In the initial step, the overriding hypothesis of homogeneity will test the entire distribution of ES separately for the reduction of anxiety, reduction of depression, and for the promotion of pregnancy. This will be called the psychotherapy total homogeneity test. Subsequently, this Fixed Effects Model and the corresponding analysis of variance (ANOVA)-Analog (ANOVA-Analog, Lipsey and Wilson, 2001) will attempt to evaluate possible systematic variation using the above-mentioned moderator variables. The moderator variables were selected according to computed qualitative and quantitative mean values extracted from the studies. The chosen ANOVA categorical moderator variables are as follows: psychotherapy type (group/individual/couple), number of psychotherapy sessions (<9 sessions, >10 sessions), follow-up time (<6 months, >6 months), as well as the additional moderator variable psychotherapy-supported IVF versus psychotherapy alone without specific medical treatment for the promotion of pregnancy. Ultimately, a post hoc descriptive comparison is made between the computed ES for the reduction of negative emotional symptoms and for the rate of conception in relation to the moderator variables investigated.
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Results |
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Reduction of anxiety and depression
Seven individual and couple psychotherapies and four group psychotherapies fulfilled selection criteria and could be evaluated. The intervention customarily took place in a clinical setting. Emery et al. (2001), Strauss et al. (2001)
and Wischmann (1998)
aimed to reduce negative affect through individual and couple counselling. Bents (1991)
and Tuschen-Caffier et al. (1999)
attempted to truncate negative symptoms through cognitive behavioural concepts for individuals and couples. Takefman et al. (1990)
administered other individual/couple interventions by presenting their participants with preparatory information on infertility and IVF procedures, and Connolly et al. (1993)
combined both counselling and information concepts. Domar et al. (1999)
and Galletly et al. (1996a)
offered their participants cognitive behavioural comprehensive group programmes. Finally, McNaughton-Cassill et al. (2000)
and Stewart et al. (1992)
based their intervention on anti-stress support groups.
Participants
Treatment group couples and women consisted of individuals specifically seeking medical support and psychotherapy. The average age across studies for women and couples was 33 years. Strauss (1991) maintains that psychological factors are most likely to be found in idiopathic infertility, or in an unknown genesis, as found in the studies by Tuschen-Caffier et al. (1999)
and Wischmann (1998)
. Other studies described their sample as having multiple infertility origins (Bents, 1991
; Domar et al., 1999
; Strauss et al., 2001
). Patients were classified as suffering from either primary infertility and/or secondary infertility in the following studies: primary infertility (Takefman et al., 1990
; Bents, 1991
; Galletly et al., 1996a
; Wischmann et al., 1998
; Tuschen-Caffier et al., 1999
; Emery et al., 2001
; Strauss et al., 2001
), and both primary and secondary infertility (Stewart et al., 1992
; Connolly et al., 1993
; Domar et al., 1999
; McNaughton-Cassill et al., 2000
).
Bents (1991), Takefman et al. (1990)
and Domar et al. (1999)
reported that their therapy participants were married. The average duration of a relationship was 8 years (Bents, 1991
; Emery et al., 2001
). With regard to level of education, Domar et al. (1999)
report that their 132 women participants have a mean of 17.1 (SD=2.0) years of education completed, indicating a higher level of career qualification.
Psychological measures
The studies shared similar self-report measurement instruments in the evaluation of emotional symptoms. The most commonly used instrument was the State-Trait Anxiety Inventory (STAI) (Spielberger et al., 1970; Spielberger, 1988), which assesses situation-induced (state) and personality latent (trait) anxiety. STAI was administered to patients in the studies of Takefman et al. (1990), Connolly et al. (1993)
and Emery et al. (2001)
. Aside from STAI, Connolly (1993) also provided the Profile of Moods Scale (McNair, 1971
) to assess fluctuating affective states of depression. Beck's Depression Inventory (Beck and Steer, 1987
), as well as the Symptom Checklist (Revised) (SCL-90-R) (Derogatis, 1977
), designed to assess psychological distress, were both administered by Domar et al. (1999)
. Wischmann (1998)
and Strauss et al. (2001)
utilized the SCL-90 for the parallel collection of anxiety and depression data. Stewart et al. (1992)
chose the Brief Symptom Inventory (Derogatis and Spencer, 1982
) for affect assessment. Bents (1991)
employed the Emotional Inventory-State (Ullrich and Ullrich DeMuynch, 1977), in order to attain information on specific emotional stress reactions, including anxiety and depression. Galletly et al. (1996a)
, utilized the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983
), and McNaughton-Cassill (2000)
distributed self-report questionnaires generally to infertile patients within the Wilford Hall Medical Center, Texas to rate anxiety and depression. Ultimately, Tuschen-Caffier et al. (1999)
incorporated a specialized Kognitionen bei Infertilität: Entwicklung und Validierung eines Fragebogens (KINT) questionnaire (Pook et al., 1999
), which was developed in order to assess infertility-specific cognitions significantly correlated to depression.
Study design
Three comparison groups were defined as Wait-List controls (Bents, 1991; Wischmann, 1998
; Strauss et al., 2001
). Wischmann (1998)
and Strauss et al. (2001)
formed comparison groups by combining wait-list subjects, non-compliers to psychotherapy, as well as patients pursuing routine medical care into comparison pools. Other researchers re-grouped treatment subjects who failed to return final data into post hoc control groups (Galletly et al., 1996a
). Finally, studies relied on control participants in routine medical care (Stewart et al., 1992
; Tuschen-Caffier et al., 1999
; McNaughton-Cassill et al., 2000
; Emery et al., 2001
). Five comparison group studies relied on randomization of subjects (Wallace, 1984
; Takefman et al., 1990
; Connolly et al., 1993
; Emery et al., 2001
; Strauss et al., 2001
). Four studies refrained from randomization and integrated routine care control subjects (Stewart et al., 1992
; Tuschen-Caffier et al., 1999
; McNaughton et al., 2000
), or including therapy drop-out participants (Galletly et al., 1996a
).
Quantitative findings
Using the standardized mean gain, separate computations were made for treatment groups, control groups, group/individual/couple psychotherapy for anxiety (Table II) and depression (Table III).
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Investigating studies measuring depression revealed only one of the three moderator variables to be significant. The mean follow-up interval (Q-value 6.94) suggests that a significant contribution to explained effect size variation may be given (2=3.841, df 1, P<0.05). The weighted mean effect size for follow-up after the 6 months marker following therapy termination (ES=0.42) was greater than the value computed for the follow-up measured within the 6 months following therapy termination (ES=0.11). The moderator variables psychotherapy type (Q-value 0.66) and number of psychotherapy sessions (Q-value 0.01) were non-significant, and thus could not explain unknown variance. ES for comparison groups were routinely computed but could not be directly compared to the treatment values due to missing reciprocal study control groups and due to partial lack of randomization within the individual study concepts.
Pregnancy rate
The set of research studies investigating diverse psychotherapies for pregnancy promotion took place in a clinical/university clinic setting and consisted of nine individual/couple and seven group psychotherapies (Table I). Six interventions were geared towards counselling for infertile women and couples using either cognitive behavioural, focal, resource or psychoanalytic methods (Sarrel and DeCherney, 1985
; Bents, 1991
; Brandt and Zech, 1991
; Emery et al., 2001
; Hölzle et al., 2001
; Strauss et al., 2001
). Quinn and Pawson (1994)
attempted to support successful conception with hypnotherapy; Takefman et al. (1990)
chose preparatory information as their intervention of choice and Tuschen-Caffier et al. (1999)
offered supportive sexual therapy. Christie and Morgan (2000)
conducted psychoanalytic group therapy. Clark et al. carried out two studies using cognitive behavioural group psychotherapy on the same sample. For this reason, the results were aggregated and counted as one complete study intervention (Clark et al., 1995
, 1998
). Galletly et al. (1996b)
and Domar et al. (1990
, 1992
, 1999
, 2000
) also administered comprehensive group psychotherapy programmes to infertile persons.
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Quantitative results
The hypothesis of homogeneity for the entire distribution of ES yielded heterogeneous ES for the set of pregnancy rate studies (Q-value: 494.58, 2=24.996, df 15, P<0.05). The results of moderator variables utilized in the ANOVA-Analog were recorded as the Q-between value. This is given as the critical value of
2 at P<0.05 and understood as the number of categories minus 1 [
2 of 3.841, df 1]. Psychotherapy type (Q-value: 3.98) was significant as compared to the number of psychotherapy sessions (Q-value: 23.61) and to follow-up time (Q-value: 34.07). All significant values suggest that the moderator variables distinguish the differences in groups correctly by demonstrating a between-groups effect, thereby contributing to clarification of unknown variance. Finally, the moderator variable psychotherapy-supported IVF versus psychotherapy alone did not contribute significantly to explained effect size variation (Q-value: 0.09).
The overall given pregnancy rate for psychotherapy treatment across all studies amounted to 284 from 628 participants (45%). In comparison, results showed that only 18 patients from 129 in the control groups were reported to be pregnant or to have conceived by study termination (14%). Table V gives the proportion effect sizes for each moderator variable (PES) and the percentage of reported conception for each group. Individual/couple and group psychotherapies as well as psychotherapy with or without accompanied IVF treatment both yielded similar pregnancy rates. More than 10 sessions of psychotherapy and a follow-up time >6 months after therapy termination led to a larger conception count.
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Discussion |
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The moderator variable utilized in the ANOVA-Analog revealed, with regard to anxiety, a small between-groups effect for individual/couple therapy (ES=0.17) and group therapy (ES=0.36), suggesting that both psychotherapy types yield positive effects for patients. This is in line with McRoberts et al. (1998) who state that group and individual/couple therapies have been similarly effective when compared with each other. For depression, the weighted mean effect size for the moderator variable follow-up after the 6 months marker following therapy termination (ES=0.42), as compared to follow-up measured within the 6 months following therapy termination (ES=0.11), supports the theory that depressive symptoms increase with length of infertility duration (Domar et al., 1992
; Strauss et al., 2000
), and that women and couples may be more receptive to support provided earlier in therapies than at a later point in time. ES for comparison groups were routinely computed but could not be compared to the treatment values due to missing reciprocal study control groups and due to partial lack of randomization within individual study concepts.
The (proportion) ES computed for psychotherapy influence on possible conception reflected the fact that the study reported pregnancy rate count. Individual/couple and group psychotherapies yielded similar pregnancy rates, which would provide possible further support for the efficacy of both types of psychotherapy (McRoberts et al., 1998). With 9 months gestation in mind, it would appear reasonable to suppose that >10 sessions of psychotherapy and a follow-up time >6 months upon therapy termination would ultimately lead to an improved reported pregnancy outcome (PES: 0.65 and 0.60 respectively). Interestingly, the pregnancy rates for both psychotherapy-supported IVF and for psychotherapy alone appear to be identical (PES: 0.45). Other possible evidence for psychotherapy efficacy for infertile persons was given in the resulting overall given pregnancy rate for psychotherapy treatment across studies as compared to the control group rate (14%).
Nevertheless, it is difficult to attribute psychotherapy intervention success to possible pregnancy promotion when biasing factors such as medical treatment are involved. For this reason, a definite connection between psychotherapy efficacy and successful conception cannot be made at this point.
There were, however, many other limitations to generalizing these study results. For example, as mentioned earlier, many of the studies included did not supply a comparison group design. Simple pre/post measurements with standardized questionnaires before and after treatment cannot rule out the plethora of interacting effects on change reported. This dilemma also holds true for the studies including comparison groups but failing to randomize their participants. Clark et al. (1995, 1998
) introduced drop-outs from the initial recruitment as comparison groups in both studies. Not only were these subjects previously informed of the treatment but they may have had personal bias against psychotherapy altogether. Randomizing entails the selection of a number of cases from the entire population of persons in such as way as to ensure that any one subject has the same chance of being chosen as any other. This establishes that the sample will be a valid representation of the entire population. Only randomized controlled studies may truly defy systematic differences and, with some confidence, attribute change to the treatment itself.
Additionally, results from psychological variables may vary from study to study due to differences in study designs and differences in patient characteristics of the treatment and control group, type and length of infertility, varying follow-up times, as well as the patient information collection interval (before, during, following IVF treatment). One reviewer commented that the moderator variables investigated (follow-up time, etc.) are actually correlated, making it difficult to attribute any effects of psychotherapy to the treatment itself. In fact, Lipsey and Wilson (2001) indicate that relative comparisons of ES across studies are inherently correlational, making this a fundamental weakness of meta-analysis. Since important study features are often confounding, this may obscure the interpretive meaning of observed differences. Future analyses could attempt to model out substantive influences by including multivariate methods.
The bulk of the studies described their subjects as women and couples participating in medical infertility diagnostic procedures and treatment. This may imply that IVF patients overly represent study participants. Also little is known about women and couples experiencing infertility who undergo other forms of infertility treatment or those who refrain from any form of medical treatment. Greil (1997) contends that this may account for 50% of all infertile women and couples. Furthermore, it proved difficult to differentiate between the psychological consequences of the infertility diagnosis and those resulting from the medical treatment regimen, since the bulk of studies recruited their participants from clinical populations. Prospective studies should be geared towards the comparison of clinical and non-clinical populations with regard to psychological impact of infertility, adjustment, as well as to pregnancy rates.
Another potential bias involves the independence of ES. Lipsey and Wilson (2001) suggest that ES may be presumed to be statistically independent if, for a given distribution, no more than one effect size comes from any given subject sample. However, one must keep in mind that subject samples within studies may be independent, but not necessarily between study samples. This means that we cannot know for sure whether subjects may have simultaneously or successively taken part in any of the other research studies presented, and thus, we cannot definitely state whether the corresponding ES computed from these studies are really independent from each other.
Other methodological drawbacks within the studies include the use of self-report questionnaires that may lead patients to adhere to facets of social desirability in answering questions. Henning and Strauss (2000) comment that this form of response tendency is actually expected from infertile couples entering medical infertility treatment. These patients feel under pressure to appear normal in order to focus attention on the medical (and not psychological) aspects of their infertility, thus qualifying for a medical treatment programme.
Finally, Lipsey and Wilson (2001) emphasize the fact that even a small number of studies may be meta-analysed, but at the cost of potential upward sampling bias.
Extensive research still needs to be conducted before the precise relationship between psychotherapy for infertility and outcome is understood. Results indicate that both group psychotherapy and also individual/couple psychotherapy supply evidence of positive effects in the alleviation of anxiety and depression in infertile patients. This is in line with the systematic review carried out by Boivin (2003). However, in comparison to the Boivin (2003)
study, our meta-analysis has also indicated possible evidence for the enhancement of conception success through psychotherapy. This is an interesting discrepancy considering the fact that both studies incorporated a similar study pool. It may be possible to infer that the main outcome differences are due to the utilization of various evaluation instruments and also to a separate study focus. Whereas this meta-analysis utilized the PES statistic based on treatment groups, Boivin compared treatment versus control groups in measuring pregnancy. Hence, since the study pool in our analysis included a greater number of treatment-only studies, a stronger indication for pregnancy outcome through psychotherapy was suggested.
Unfortunately, although there may be some form of influence of psychotherapy on pregnancy, strong interacting bias in our analysis prevents us from making a definite connection between psychotherapy efficacy and possible conception success. Meta-analysis is effective in comparing results across studies in a methodological fashion, yet cannot go beyond the limitations of the data upon which it is based. As Lipsey and Wilson (2001) put it, most meta-analyses include blemished studies. For this reason, it is imperative that future research studies adhere to strict methodological principles. Ideally, future research on psychotherapy efficacy for infertility could incorporate both systematic and meta-analytic features in a larger scale evaluation involving only randomized studies. In this sense, both the systematic review and the meta-analytic approaches must not be viewed as rival evaluation approaches, but rather seen as interlocking contributors to research on psychotherapy. Both evaluation approach outcomes could be subsequently critically cross-evaluated in order to sift out possible further hidden bias. In turn, results from such controlled evaluation studies may help further to evaluate the efficacy of psychotherapy for infertility patients.
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Acknowledgements |
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Submitted on April 5, 2004; resubmitted on December 7, 2004; accepted on December 14, 2004.
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