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For Better or Worse: An Individual Patient Data Meta-Analysis of Deterioration Among Participants Receiving Internet-Based Cognitive Behavior Therapy
Stockholm University, Faculty of Social Sciences, Department of Psychology, Clinical psychology.
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2016 (English)In: Journal of Consulting and Clinical Psychology, ISSN 0022-006X, E-ISSN 1939-2117Article in journal (Refereed) In press
Abstract [en]

Objective: Psychological treatments can relieve mental distress and improve well-being, and the dissemination of evidence-based methods can help patients gain access to the right type of aid. Meanwhile, Internet-based cognitive–behavioral therapy (ICBT) has shown promising results for many psychiatric disorders. However, research on the potential for negative effects of psychological treatments has been lacking. Method: An individual patient data meta-analysis of 29 clinical trials of ICBT (N = 2,866) was performed using the Reliable Change Index for each primary outcome measures to distinguish deterioration rates among patients in treatment and control conditions. Statistical analyses of predictors were conducted using generalized linear mixed models. Missing data was handled by multiple imputation. Results: Deterioration rates were 122 (5.8%) in treatment and 130 (17.4%) in control conditions. Relative to receiving treatment, patients in a control condition had higher odds of deteriorating, odds ratios (ORs) = 3.10, 95% confidence interval (CI) [2.21, 4.34]. Clinical severity at pretreatment was related to lower odds, OR = 0.62, 95% CI [0.50, 0.77], and OR = 0.51, 95% CI [0.51, 0.80], for treatment and control conditions. In terms of sociodemographic variables, being in a relationship, OR = 0.58, 95% CI [0.35, 0.95], having at least a university degree, OR = 0.54, 95% CI [0.33, 0.88], and being older, OR = 0.78, 95% CI, [0.62, 0.98], were also associated with lower odds of deterioration, but only for patients assigned to a treatment condition. Conclusion: Deterioration among patients receiving ICBT or being in a control condition can occur and should be monitored by researchers to reverse and prevent a negative treatment trend.

Place, publisher, year, edition, pages
2016.
Keyword [en]
Internet-based cognitive behavior therapy, individual patient data meta-analysis, negative effects, deterioration, predictors
National Category
Psychology
Research subject
Psychology
Identifiers
URN: urn:nbn:se:su:diva-135341DOI: 10.1037/ccp0000158OAI: oai:DiVA.org:su-135341DiVA: diva2:1044637
Available from: 2016-11-04 Created: 2016-11-04 Last updated: 2016-12-19
In thesis
1. Negative effects of Internet-based cognitive behavior therapy: Monitoring and reporting deterioration and adverse and unwanted events
Open this publication in new window or tab >>Negative effects of Internet-based cognitive behavior therapy: Monitoring and reporting deterioration and adverse and unwanted events
2016 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Internet-based cognitive behavior therapy (ICBT) has the potential of providing many patients with an effective form of psychological treatment. However, despite helping to improve mental health and well-being, far from everyone seem to benefit. In some cases, negative effects may also emerge. The overall aim of the present thesis was to establish the occurrence and characteristics of such incidents in ICBT using a combination of quantitative and qualitative methods. Study I determined deterioration, non-response, and adverse and unwanted events in a sample of 133 patients undergoing ICBT for social anxiety disorder. The results indicated that up to 6.8% fared worse during the treatment period, depending on the self-report measure and time point, as determined using the Reliable Change Index (RCI), while the non-response rate was between 29.3 to 86.5% at post treatment assessment, and 12.9% experienced other negative effects. Study II investigated the responses to open-ended questions on adverse and unwanted events among 556 patients in four separate clinical trials of ICBT; social anxiety disorder, panic disorder, major depressive disorder, and procrastination. In total, 9.3% reported negative effects, with a qualitative content analysis revealing two categories and four subcategories; patient-related, i.e., gaining insight and experiencing new symptoms, and treatment-related, i.e., difficulties applying the treatment interventions and problems related to the treatment format. Study III explored the number of patients achieving reliable deterioration, as determined using the RCI on the individual raw scores of 2866 patients from 29 clinical trials of ICBT. The results showed that the deterioration rate was higher among patients in a control condition, 17.4%, in comparison to treatment, 5.8%. Predictors were related to decreased odds of deterioration for patients receiving treatment; clinical severity at pre treatment assessment, being in a relationship, having a university degree, and being older. As for the control condition, only clinical severity at pre treatment assessment was associated with decreased odds of deterioration. Study IV examined a newly developed self-report measure for monitoring and reporting adverse and unwanted events, the Negative Effects Questionnaire. The results suggested a six-factor solution with 32 items; symptoms, quality, dependency, stigma, hopelessness, and failure. One-third of the patients reported experiencing unpleasant memories, stress, and anxiety, with novel symptoms and a lack of quality in the treatment and therapeutic relationship having the greatest negative impact. The general finding of the present thesis is that negative effects do occur in ICBT and that they are characterized by deterioration, non-response, and adverse and unwanted events, similar to psychological treatments delivered face-to-face. Researchers and clinicians in ICBT are recommended to monitor and report negative effects to prevent a negative treatment trend and further the understanding of what might contribute to their incidents. Future research should investigate the relationship between negative effects and treatment outcome, especially at follow-up, to examine if they are transient or enduring. Also, interviews could be conducted with those achieving reliable deterioration to explore if and how it is experienced by the patients and to see if it is attributed to the treatment interventions or other circumstances.

Abstract [sv]

Internetbaserad kognitiv beteendeterapi (IKBT) har goda förutsättningar att kunna bli en form av psykologisk behandling som på ett effektivt sätt hjälper patienter med att hantera sin psykiska ohälsa och förbättra sitt välmående. Trots detta är det dock långtifrån alla som tycks bli bättre. För en del kan det till och med resultera i negativa effekter. Det övergripande syftet med denna avhandling har således varit att undersöka förekomsten av sådana fall och hur dessa uttrycks, såväl med kvantitativa som kvalitativa metoder. Studie I fastställde andelen försämrade, oförändrade samt andra ogynnsamma eller oönskade händelser bland 133 personer som behandlades med IKBT för social ångest. Resultatet visade att uppemot 6,8 % försämrades under sin behandlingsperiod beroende på vilket självskattningsformulär respektive tidpunkt som studerades, beräknat enligt metoden Reliable Change Index (RCI). Likaså var 29,3 % till 86,5 % oförändrade vid eftermätningen samt att 12,9 % rapporterade andra former av negativa effekter. Studie II undersökte svaren på öppna frågor som gällde ogynnsamma eller oönskade händelser bland 556 patienter i fyra olika kliniska studier med IKBT; social ångest, paniksyndrom, egentlig depressionsepisod och prokrastinering. Totalt sett rapporterade 9,3 % att de hade erfarit negativa effekter, vilka analyserades med hjälp av kvalitativ innehållsanalys. Två övergripande kategorier och fyra subkategorier framkom; patientrelaterade, som ökad insikt respektive nya symptom, samt behandlingsrelaterade, som svårigheter att implementera behandlingsinterventionerna respektive problem med behandlingsformatet. Studie III utrönte andelen patienter som försämrades i enlighet med RCI, baserat på insamlad rådata från 2866 personer i 29 olika kliniska studier med IKBT. Resultatet visade att försämring var mer förekommande hos de som var i en kontrollgrupp, 17,4 %, jämfört med de som fick behandling, 5,8 %. Bland de som genomgick behandling existerade det även ett par prediktorer som innebar lägre odds för försämring; större svårigheter vid förmätningen, att befinna sig i en relation, att ha en universitetsutbildning respektive att vara äldre. För de som var i en kontrollgrupp var enbart större svårigheter vid förmätningen relaterat till lägre odds för försämring. Studie IV testade ett nykonstruerat självskattningsformulär; Negative Effects Questionnaire. Resultatet visade på en faktorlösning med sex faktorer och 32 påståenden; symptom, kvalitet, beroende, stigma, hopplöshet respektive misslyckande. En tredjedel av personerna svarade att de hade upplevt obehagliga minnen, stress och ångest, samtidigt som nya symptom och bristande kvalitet i både behandlingen respektive den terapeutiska relationen hade haft störst negativ inverkan på dem. Den generella slutsatsen av denna avhandling är således att negativa effekter förekommer i IKBT och att de kännetecknas av försämring, ett oförändrat tillstånd samt andra ogynnsamma eller oönskade händelser, något som liknar tidigare forskning av psykologisk behandling som bedrivs ansikte-mot-ansikte. Forskare och behandlare i IKBT rekommenderas att övervaka och rapportera negativa effekter i syfte att förhindra en negativ utveckling i behandlingen samt för att öka kunskapen om vad som kan bidra till deras förekomst. Framtida forskning bör undersöka relationen mellan negativa effekter och behandlingsutfall utifrån längre tidsperspektiv för att se om dess påverkan är övergående eller ihållande. Vidare kan till exempel intervjuer utföras med de patienter som har försämrats för att ta reda på om och hur det uppfattas samt huruvida det har förorsakats av behandlingen eller andra omständigheter.

Place, publisher, year, edition, pages
Stockholm: Department of Psychology, Stockholm University, 2016. 89 p.
Keyword
Negative effects, Internet-based cognitive behavior therapy, deterioration, non-response, adverse and unwanted events, qualitative content analysis, individual patient data meta-analysis, exploratory factor analysis, Negative Effects Questionnaire, Negativa effekter, Internetbaserad kognitiv beteendeterapi, försämring, oförändrat tillstånd, ogynnsamma eller oönskade händelser, kvalitativ innehållsanalys, individuell patient meta-analys, explorativ faktoranalys, Negative Effects Questionnaire
National Category
Social Sciences Psychology Applied Psychology
Research subject
Psychology
Identifiers
urn:nbn:se:su:diva-135382 (URN)978-91-7649-597-1 (ISBN)978-91-7649-598-8 (ISBN)
Public defence
2017-02-03, David Magnussonsalen (U31), Frescati Hagväg 8, Stockholm, 10:00 (English)
Opponent
Supervisors
Funder
Forte, Swedish Research Council for Health, Working Life and Welfare, 2013-1107
Note

At the time of the doctoral defense, the following paper was unpublished and had a status as follows: Paper 4: In press.

Available from: 2017-01-11 Created: 2016-11-08 Last updated: 2016-12-19Bibliographically approved

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