An interventional study of Positive Psychology Intervention and Cognitive Behavior Therapy in Postpartum Depression and Postpartum Disorder, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.
Participants will be randomly assigned to the CBT group or the PPI group. Both groups will be treated identically except for the type of intervention. Group assignment will be blind to both patients and investigators.
Both interventions have 10 weekly sessions. Sessions will be in groups and online.
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. CBT approach; (2) Stress and Anxiety. Relaxation; (3 and 4) Increase pleasurable activities. Balance in life. To manage time; (5) Management of negative thoughts. Health concerns; (5 and 6) Increase positive thoughts; (7) social skills; (8) Communication skills and parner support; (9) Plan for the future. New routines and strategies; (10) Relapse prevention. CBT has been shown to be effective in reducing depressive symptoms and modifying attentional biases (Pearson et al., 2013).
On the other hand, a new protocol of positive interventions adapted for women after maternity (PPI) will be designed and applied. This multicomponent protocol includes interventions that have already been empirically validated in treating depression. PPI includes 2 modules: hedonic well-being and eudaimonic well-being. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. PPI approach; (2) Mindfulness and positive emotions; (3) Gratitude and savoring; (4) Emotion regulation (5) Positive relationships and social support; (6) Compassion; (7) Personal strengths; (8) Goals and values; (9) Resilience; (10) Relapse prevention.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 98 is close to the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ten weekly sessions. Session duration: 90 minutes.
Behavioral: Positive Psychology Intervention
Ten weekly sessions. Session duration: 90 minutes.
Behavioral: Cognitive Behavior Therapy
PPI includes 2 modules: hedonic well-being and eudaimonic well-being.
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
Postpartum depression change
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.
Time frame: Immediately before and after the intervention
Positive and Negative Affect change
Positive and Negative Affect Scale (PANAS). Positive emotions scores range from 10 to 50, where higher scores mean a better outcome. Negative emotions scores range from 10 to 50, where higher scores mean a worse outcome.
Time frame: Immediately before and after the intervention
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Satisfaction With Life Scale
Time frame: Immediately before and after the intervention
Beliefs about pregnancy change
The Pregnancy Related Beliefs Questionnaire (PRBQ-8). Scores range from 8 to 56. Higher scores indicate greater levels of dysfunctional attitudes towards motherhood.
Time frame: Immediately before and after the intervention
Psychological well-being change
Psychological well-being scale by Ryff (PWBS). PWBS-29 is composed for 29 items with a minumum score of 29 and a maximum score of 174. Self-acceptance scores range from 4 to 24; Positive Relationships with others scores range from 5 to 30; Autonomy scores range from 6 to 36; Environmental mastery scores range from 5 to 30; Purpose in life scores range from 5 to 30 and Personal Growth scores range from 4 to 24. Higher score in each subscale means a better outcome.
Time frame: Immediately before and after the intervention
Maternal filial bond in the postpartum change
The Postpartum Bonding Questionnaire (PBQ). Scores Range from 0 to 120. General factor scores range from 0 to 60 (Cut-off score 11= normal, 12 = high). Rejection of the infant scores range from 0 to 35. (cut-off 16 = normal, 17 = high). Infant-focused anxiety scores range from 0 to 10 (cut- off 9 = normal, 10 = high). Incipient abuse scores range from 0 to 10 ( cut-off 2 = normal, 3 = high). A high score in each factor indicates pathology.
Time frame: Immediately before and after the intervention
Maternal self-efficacy change
Maternal Self-efficacy Questionnaire (MSQ). Scores range from 10 to 40, where equal or greater scores than 31 means a high perception of maternal self-efficacy.
Time frame: Immediately before and after the intervention
Plan to share: Yes — Information on the evaluation and intervention protocol can be requested from the researchers. Likewise, the individual participant data can be provided on demand to guarantee the transparency of the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Since the end of the study (June 2024) and for 10 years
Access criteria: The individual participant data can be provided on demand to guarantee the transparency of the study.
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2025, 28 months after the start.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 28 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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